Winston-Salem, NC – Clinical ink, a global life science technology company, announced the launch of EDCXtra, an innovative Electronic Data Capture (EDC) system. EDCXtra is based on the company’s best in class direct data capture (DDC)/eSource platform, which has evolved over 17 years, and resulted in multiple FDA approvals. EDCXtra incorporates all existing DDC functionality into a single web-based application which includes Clinical ink’s industry leading electronic Clinical Outcome Assessments (eCOAs) and eConsent solutions, providing a comprehensive, all-in-one GCP compliant platform.

EDCXtra is designed to operate in hybrid mode, allowing sites the flexibility of entering Case Report Form (CRF) data in real-time along with complex eCOAs in a single interface, or to use paper CRF transcription methods and enter data into the EDC later.

EDCXtra also offers electronic consent (eConsent) and integration via API with other eClinical systems including interactive response technology (IRT) and Laboratory Data. This fully customizable solution adapts to the specific needs of each trial.

“We developed EDCXtra to improve the site experience by providing a single flexible EDC/DDC solution,” said Megan Petrylak, EVP, Clinical Operations at Clinical ink. “The integration of EDCXtra in our end-to-end eClinical suite improves speed and quality of data capture while significantly reducing the administrative burden on sites. Sponsors benefit from the simplicity and cost advantage of a single study build for EDC and complex eCOAs, as well as the customizable integration of 3rd party data systems such as IRT and central laboratory.”

For more information about EDCXtra or to schedule a demo, please visit clinicalink.com or contact info@clinicalink.com.

About Clinical ink

Clinical ink is the the global life science company bringing data, technology, and patient-centric research together. Our deep therapeutic-area expertise, coupled with EDC, Direct Data Capture, eCOA, eConsent, telehealth, and digital biomarkers advancement (including the use of Blood and Continuous Glucose Monitoring for detection of hypoglycemia), support the next generation of clinical trials and ultimately, the clinical management of patients.

The post Clinical ink announces EDCXtra™ : An integrated web-based EDC, DDC and eCOA platform appeared first on Clinical ink.

A Burden on Time and Resources

The process of ethics committee review often involves meticulous scrutiny of trial-related documents, with the aim of safeguarding patient rights, welfare, and well-being. However, the existing practice of demanding all translations of eCOA materials as screenshots has come under scrutiny. This practice places a significant burden on study teams, sponsors, and providers of eCOA systems. Additionally, it can lead to unintended delays in study approvals, hampering the timely initiation of clinical trials and, consequently, access to potential therapies for patients.

An Ethical and Efficient Approach

Advocates of change argue that the focus of ethics committee reviews should center on patient rights, welfare, and safety, rather than demanding exhaustive translations of all eCOA materials. This perspective is in line with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use’s (ICH) Guideline for Good Clinical Practice (GCP), which emphasizes patient consent, recruitment, and safety. The key points in favor of this revised approach include:

Contextual Examination: ICH GCP specifies that ethics committees should review written information intended for informed consent and recruitment purposes. This implies that the review of diaries and questionnaires, which serve a scientific purpose in data collection, should be treated differently from consent-related materials.

Scientific Relevance: A thorough examination of the English versions of eCOA materials allows ethics committees to assess the scientific relevance, history of validation, and sensitivity of content.

Patient Burden: Ethical oversight should focus on evaluating the potential burden on trial participants and assessing any incentives that might influence patient participation. 

Quality of Translation: Instead of requiring exhaustive translations of eCOA content, ethics committees can rely on certificates of translation (CoTs) as evidence of rigorous translation processes.

Efficiency: Approaching eCOA review in this way can streamline the ethics committee approval process, reduce administrative burden, and facilitate timely initiation of clinical trials, thus expediting access to potential treatments for patients.

Clinical ink’s Expertise Aligns with this Approach

1. Streamlined eCOA Review

Clinical ink’s eCOA solutions can significantly streamline the review process by providing comprehensive questionnaires and diaries, allowing ethics committees to focus on the scientific relevance, patient burden, and safety aspects. Clinical ink technology empowers trial sponsors to present these materials in an organized, standardized, and easily accessible manner, reducing administrative complexity and accelerating the review process.

2. Scientific Scrutiny and Patient Welfare

By providing accurate and validated eCOA instruments, Clinical ink helps sponsors uphold the highest quality standards in data collection while ensuring that patients’ needs and well-being are prioritized.

3. Efficient Translation Management

Clinical ink solutions facilitate efficient translation management by enabling accurate and timely translations of eCOA content while maintaining quality and consistency. This feature resonates with the recommendation to provide certificates of translation (CoTs) as evidence of rigorous translation practices.

4. Timely Study Initiation

Clinical ink supports timely study initiation, reducing the time-to-market for potential therapies. This aspect is crucial for both the scientific advancement of treatments and improving patient access to novel interventions.

5. Access to Quality Data

Clinical ink eCOA solutions ensure that high-quality data is collected from patients, addressing the potential compromise on data quality when sponsors resort to paper diaries and questionnaires due to perceived efficiency gains. 

Embracing a New Ethical Standard

The proposed shift in eCOA review practices encourages ethics committees to focus on their core responsibilities while allowing the scientific community to maintain the high standards required for research integrity. By offering comprehensive eCOA solutions, Clinical ink empowers clinical trial stakeholders to navigate the evolving landscape of ethical oversight and operational efficiency while advancing medical research and improving patient care.

Contact us to learn more about how Clinical ink’s eCOA solutions can enhance your trial efficiency.

Bill Barrasso, Chief Compliance Officer at Clinical ink, contributed to a Bloomberg BNA article that highlights the challenges and shift in thinking outlined above.

Read the full article, “Optimizing Electronic Clinical Outcome Assessment Materials Required for IRBIEC,” by submitting our interest form.

The post Rethinking eCOA Review: A Shift Toward Efficiency and Ethical Oversight appeared first on Clinical ink.

It is no surprise that patient recruitment and retention continue to be a leading cause of study delays and trial failures. It’s not because patients don’t want to participate, but because traditional clinical trials make it difficult to.

• 85% of clinical trials fail to recruit enough patients, and 80% are delayed due to recruitment problems¹. 
• The average drop-out rate for clinical trials hovers around 30%².

The COVID pandemic has been a catalyst of change, with the industry adoption of digital solutions that enable remote clinical trials while still preserving data quality and regulatory compliance. Remote patient engagement technology comes in many forms, from simple telehealth calls to wearable sensors that transmit participants’ data on a near-constant basis. 

Clinical trial sites now increasingly embrace remote patient engagement technology:

• 94% of research sites³ offer telemedicine visits
• 93% use electronic patient diaries and 
• 92% use electronic informed consent documents

Sponsors are also increasingly looking to incorporate remote solutions in their studies. Prior to the pandemic in December 2019, an industry survey found that 38 percent of life sciences companies and Contract Research Organizations (CROs) planned to use some aspect of virtualization in their trials. That number jumped to 100 percent a year later⁴. 

When digital technologies are introduced, clinical trial access for patients drastically increases, leading to better enrollment numbers, larger data sets, and greater patient diversity. Patient engagement technology plays a critical role in patient-centric clinical trials to make trials more convenient for patients. 

Roughly 85% of the American population own a smartphone⁵.  Smartphones, computers, and WiFi have transformed how patients approach healthcare and enable study participation, despite income, site proximity, transportation, or work/life circumstances.  Even in cases where participants do not own smart devices, smartphones can be provisioned, which ultimately increases accessibility and community inclusion. 

Technology solutions like online diaries, telemedicine calls, clinical assessments, sensors, and wearables can help participants join trials and compliantly participate without going to the site for every visit. The best eSource tools help patients stay on track by providing notifications with information in the form of simple “to-do” lists with reminders for visits and scheduled events, as well as visit descriptions, fast facts, study goals, and objectives.

Additionally, remote patient monitoring can help maintain regimen adherence with frequent contact via text reminders and phone calls, which are often automated. Digital automation in a clinical trial reduces the logistical burden on site staff while benefiting trial participants. In cases where participants are required to perform a task with their device, the study team can send digital reminders to improve adherence and reduce incomplete or missing data.

Patient engagement technology can also keep participants informed in a language they’re comfortable with. Software that automatically translates at-home care instructions into multiple languages allows the patient to receive accurate health and study information. 

Ultimately, the potential value for all stakeholders is high. Patients will find it easier to participate in studies, and they will likely learn more about their own health. Clinical trial sites will see reduced workloads and faster patient recruitment, in addition to providing patients with a positive experience. Sponsors will be able to take advantage of a much larger patient pool, plus see better patient retention rates – all of which should lead to faster product launches and market advantage over the competition.

Remote Clinical Trial Solutions in Action

How can you know that conducting a remote clinical trial via an electronic Patient Reported Outcome (ePRO) technology improves patient engagement and reduces patient burden? The proof is in customer success stories.  

A global Sponsor conducting a four-study neurology program needed to find a tool that would provide 10 different ePRO assessments that patients could only complete from home.  For this Sponsor, Clinical ink’s purpose-built ePRO technology ensured the trial reduced patient burden when collecting data at home by incorporating customizable alerts.

During eight at-home patient visits per study schedule, the studies achieved a total 12,330 completed ePRO scales. Clinical ink ePRO technology provided reminders for important, home- based tasks throughout the entire course. A Bring Your Own Device (BYOD) approach afforded patients the comfort and convenience of completing diaries and questionnaires with a device that fit into their daily life. Ultimately, the set up ensured the conveniences needed for patients to remain engaged in the trial, sites maintained comprehensive participant oversight, and the sponsor realized high-quality, real-time data to enable  insight-based decisions.

Read more in Clinical ink’s case study on “How a Remote ePRO Solution Helped Reduce Patient Burden.” 

Author

Nina Pruitt
Vice President, Global Strategic Marketing,
Clinical ink

Sources:

1. Decentralized clinical trials: Are we ready to make the leap?

BioPharm Dive, 29 Jan 2019

2. Considerations for Improving Patient Recruitment in Clinical Trials

Clinical Leader

3. Insights from 4 June 2021: Ship-To-Home Clinical Supplies Top List of Innovations Adopted During Pandemic

WCG Clinical

4. No place like home? Stepping up the decentralization of clinical trials

McKinsey, 10 June 2021

5. Mobile Fact Sheet

Pew Research Center, 7 April 2021

The post Remote Solutions for Better Patient Engagement appeared first on Clinical ink.

Central Nervous System (CNS) clinical outcome assessments — particularly Performance Outcome (PerfO) based measures — are among the most complex and nuanced assessments in neuropsychology clinical trials. Simplifying data collection for better data quality and signal detection relies on the innovative use of smarter electronic Clinical Outcome Assessment (eCOA) technology to streamline test administration and scoring, paired with expert clinical scientific guidance to design workflows. Advanced eCOA technology and expert scientific guidance enable dramatic improvements in assessment data collection. The results are more confident decision-making, more conclusive research, and faster delivery of new medicines to the patients who need them.

Positioned at the convergence of data and technology, the development of complex eCOA scales and assessments help advance clinical discovery. Clinical ink has supported more than 500 eCOA scales and assessments in 84 languages, leading the industry’s adoption of this powerful innovation. Partnering with Clinical ink in pursuit of driving endpoint data quality for CNS assessments is Cogstate Ltd (ASX:CGS), a leading neuroscience technology company specializing in the optimization of cognitive assessments to support the development of new therapeutics that provide earlier brain health insights in clinical care.

Clinical ink Principal Scientist Dr. Rinah Yamamoto sat down with Cogstate Neuropsychologist Dr. Robert McCue to discuss trends in clinical trials — and an exciting case — to illustrate where digital systems are being used to support data capture for complex cognitive assessments.

Rinah Yamamoto, Clinical ink Principal Scientist:
We’re here to talk about the use of cognitive assessments, like the Repeatable Battery for the Assessment of Neuropsychological Status, or RBANS, which are used in clinical trials research.

I know that these instruments are used in a variety of ways, from screening for inclusion to use as primary endpoints. As a neuropsychologist and an expert in neurocognition, can you provide some insight into the types of trials that monitor cognition and why it might be important for a clinical trial to be monitoring cognition in the first place?

Robert McCue, Cogstate Neuropsychologist:
Thanks, Rinah. So, there’s a surprisingly wide array of reasons to measure cognition in clinical trials. These include trials where cognition is an efficacy endpoint — either primary, secondary, or exploratory — such as in an Alzheimer’s or Parkinson’s disease trial, or those centered around other dementias, multiple sclerosis, or some rare diseases.

Cognition can also be used as a safety measure in some clinical trials, such as in cancer treatment, where quality of life factors are important for a drug that might extend life. For instance, what if such a drug extends life but causes quality of life to deteriorate? In that case, the drug might not be of as much value.

Cognitive testing is also used for inclusion-exclusion criteria, for example, if a study team wants to make sure someone has Mild Cognitive Impairment (MCI) and not dementia. Instruments can help more accurately narrow the study population down to a specific subset of participants or even segment the study into high-functioning and low-functioning cohorts. Also, if cognition declines, that might be a reason to discontinue a participant from the study if the drug may be causing it — discontinuation safety. There are a huge number of ways in which neurocognitive assessments are utilized in clinical trials.

These are all very important aspects that need to be considered when planning a trial. My guess is that there are probably many complex fit-for-purpose assessments to address each of them. Can you tell us a little bit about what makes cognitive assessment instruments so difficult to administer?

Many conventional assessments can be quite long and nuanced, including structured interviews and cognitive performance scales. Also, cognitive performance-based testing may include components that participants must utilize in the performance of the test. Many such scales are designed to be administered by skilled neuropsychologists, and it can be challenging for clinical trial sites to hire and retain such experienced, qualified raters. Oftentimes raters will come into a research site without an academic background in cognitive assessment or psychometric scales. Therefore, they may lack the hands-on supervised practice needed to refine these interviewing and testing skills. When you compound that with the fact that scales also appear, on the surface, to be simple, what happens is that raters end up really struggling when they first enter the clinical trials field.

There are a lot of other things that make cognitive assessment instruments challenging; it’s a bit like juggling. Until you actually try to juggle, you don’t realize just how difficult it is.

For example, raters must provide instructions to the participant accurately and appropriately. Using the standardized wording is critical and slight changes in the wording of the instructions to participants can have unanticipated effects on outcomes. Additionally, raters must present the test instructions with appropriate verbal pacing in order to avoid confusing participants who may have a diminished ability to rapidly process the instructions.

Raters also must respond appropriately to questions, and the participant may be confused about what you’re explaining to them. Sometimes you have to keep track of participant response time, where they only have so long to respond. And sometimes, you have tests where the rater has conditional responses that they give; they have to say something to the participant if the participant does something that meets a pre-specified condition. Those responses have to be ready to go automatically and quickly.

The rater can’t be reading the test manual during the test administration. Waiting for the rater to figure things out makes the participant’s experience far too frustrating. Additionally, sometimes there are materials that the rater has to put in front of the participant or take away or handle, like a tablet or printed materials. Or the participant has to draw, so you have to give them some paper and a pen.

It’s very much a multitasking type of experience for a rater, and I think that’s why some raters come in. If they’re good at that sort of thing, they actually learn very quickly, whereas some other raters — though they may ultimately be very good raters — really struggle at the beginning.

Sounds like it takes a lot of practice and training — and that those factors, along with monitoring inter-rater and intra-rater reliability — are critical aspects of performing these types of assessments.

Right. Central monitoring can be thought of as continued training, particularly for beginning raters. If they don’t have an academic background in psychometric or neurocognitive scales, that means they probably don’t have the kind of conceptual overview that could help them adapt to new scales more quickly. Also, supervised or monitored practice is part of clinical training in most fields. Without some type of review of the rater’s work, they miss out on a critical learning opportunity, and that can affect data quality.

So central monitoring of rater performance by expert clinicians is critical, but it’s very work-intensive — which means it tends to be costly, and it tends to be difficult for pharmaceutical companies to justify its expense.

But if the signal from the drug is going to be a small signal, then investing in things like eCOA and central monitoring can reduce variability to the point that the signal can be seen.

A good example of such a small-signal area is in Alzheimer’s disease, where you’re looking for a delay in cognitive decline over the course of the disease. This is slow with respect to the time span of a typical clinical trial.

Let’s talk a bit about the complexities involved in migrating traditional paper-and-pencil types of versions of these cognitive batteries to electronic formats. Maybe you could share a little about the practical differences between a computerized cognitive assessment, an electronic version, and a traditional paper-and-pencil cognitive assessment.

Cogstate was initially founded as an electronic cognitive assessment company. Our founders created some of the first computerized cognitive assessments specifically intended for use in international clinical trials. There are multiple advantages to an electronic assessment process: a major one being that variability between raters can be eliminated.

Cogstate computerized tests were developed from the outset to be international in the sense that the stimuli don’t need the kind of translation and localization that traditional neuropsychological tests require (where instructions tend to be very language heavy, and there’s often a lot more of the same in the process and the scoring). But the main advantage is that it really takes rater variability out of the equation, which is a huge help in achieving consistent data while potentially making clinical trials cheaper because you don’t need to train and monitor people as extensively.

So cognitive assessments come in a lot of different flavors — some that can be digitized into computer-administered tests, and then there are other more conventional assessments that are heavily reliant on rater administration with various language and cultural adaptations. When creating an electronic version of what has traditionally been a paper-and-pencil assessment, what are some of the goals?

Increasing reliability, certainly. Accuracy is probably the main thing, but there are a lot of operational considerations where an eSource really saves time and money. It saves the site a lot of work, saves the pharmaceutical company a lot of work, and saves companies like Cogstate a lot of work.

Electronic assessments allow central monitoring of studies, and they go far more smoothly with a direct data capture approach than with a traditional paper-and-pencil system because we can prevent many errors through scoring support and other validation checks. And for those errors that can’t be prevented, we can more rapidly identify when they occur, and there are certain automatic flags that tell us if it needs to be reviewed or not. If it does, we can have it reviewed by our central monitors, no matter where the site is; they can go in and electronically review written responses.

Many of our studies use audio recordings of the testing session so the monitors can listen to how the test was administered, which is often where we get most of our insights into whether the test was given properly or not. Once our reviewers have done their work, if there are findings that affect scores, they can be queried through the eSource technology platform.

Another big advantage of eCOA is that the data is already available as soon as the test is completed, as opposed to a research site having to scan documents and upload audio recordings and carry out manual data entry — an operational nightmare.

Do you have any insights on what clinical trial sponsors should be aware of when selecting to administer paper-and-pencil cognitive assessments in an electronic format? Taking something that would normally be a paper-and-pencil version, keeping the traditional form and layout, but converting it to an electronic format, and then administering it that way? What are the pitfalls? What are the things sponsors should be looking for, specifically?

Sponsors should be aware that eCOA may take longer during the initial startup process to make certain everything is absolutely right and ready to go. But after that, the cost savings and the time savings are where eCOA really starts to shine.

There are so many advantages in monitoring, even if it’s just a CRA checking GCP compliance, which is much easier. eCOA can fire off validations, which prompt the rater to go back in and fill something out that they may have accidentally left blank.

Sites appreciate not having huge stacks of study binders sitting around their offices. I recall a study where a research site in Tokyo became very upset when they received their shipment of study binders and refused the shipment because they simply didn’t have the space for these large study binders in their small Tokyo office. There are a lot of advantages that offset the slightly longer initial startup. Get it right at the start, and then it’ll go well thereafter.

We’ve really become very habituated to a digital world. I’d assume another big advantage of these electronic formats is not only not having to spend time transcribing results from paper into an electronic format but eliminating the potential risk of transcription errors.

Absolutely. That’s another job for the CRAs that is made so much easier and another job for the research sites that’s eliminated. They don’t have to take the time to write it on paper and then risk mistakes entering it into an EDC system. Data is directly entered into the system at once. So, it’s a big time and cost savings there as well.

Can you speak a little about how Clinical ink and Cogstate have worked together to develop electronic solutions for some of these paper-and-pencil cognitive assessments?

Clinical ink and Cogstate worked together on many cognitive assessments, but one recent example is implementing the RBANS, the Repeatable Battery for the Assessment of Neuropsychological Status. The RBANS is not just one test; it is a set of tests and an extensive undertaking to implement them — they all work together and are scored in such a way as to produce composite scores in several cognitive domains.

The kind of scoring that has to be done in the RBANS for this particular study protocol means the index scores and the total overall RBANS score both have to be derived using normative data. That’s something that clinical trial raters don’t typically do, and it can be complex and error-prone for neuropsychologists who do this every day. It’s doubly so for raters with no background in deriving standardized scores.

Because I have some background in software programming, I was impressed by how smoothly the development of the scoring went. From our initial pilot testing onward, the index scores were computed accurately.

Given the importance of the RBANS total score in this protocol, this scoring automation will be hugely helpful to the success of the study.

We’d like to thank Dr. McCue for his time and valuable perspective. Cogstate and Clinical ink have a long-standing collaboration jointly supporting CNS eCOA instruments.

Find out more about how our eCOA technology can help.

Read our eCOA solutions Fact Sheet or contact us to learn more.

The post Use of Advanced eCOA Technology Streamlines Complex Neuropsychological Assessment: RBANS® appeared first on Clinical ink.

• Improved data integrity and efficiency: Sponsors more frequently utilize electronic Clinical Outcome Assessments (eCOA) in their clinical trials – providing significant benefits in timeliness, compliance, and data integrity. 
• Remote data collection for flexibility and enhanced data quality: Collecting data remotely for electronic Patient Reported Outcome (ePRO) measures from patients wherever they are makes it easier to participate in studies. ePRO tools help overcome the inherent difficulties in interpreting patients’ handwriting on paper diaries, leading to improved data quality for Sponsors. 
• Increased patient engagement: The level of convenience and engagement for patients improves when the ePRO application can be used on a patient’s personal mobile device. Compared to a paper-based diary approach, using a Bring-Your-Own-Device (BYOD) approach can improve data quality and increase compliance by as high as 97%

An advanced ePRO offering in the CRO service portfolio can enable significant incremental business opportunities and enhance the clinical trial experience for Sponsors and patients.Until now, a CRO interested in adding ePRO technology to its portfolio had limited options:

• Build a new ePRO solution
• Acquire an existing ePRO provider

Implementing a new ePRO technology offering

The CRO should work with a partner that systematically transitions control over the implementation, deployment, and support of the ePRO solution to the CRO team. This partnership approach can enable CROs to implement an ePRO solution in-house by licensing flexible ePRO technology, purchasing support services à la carte, and ultimately creating a new revenue stream.

A successful technology transfer requires a delivery model where the vendor is willing to price their services separately and charge customers according to their use. In this way, CROs can configure a custom combination of ePRO technology and services that leverage the vendor’s existing resources for support while enabling the CRO to bill for the services it can provide, which might include some combination of project management, help desk, configuration, hardware procurement, inventory management, shipping, and support. Additionally, a CRO should consider a vendor that provides technology empowerment services, scientific expertise and dedicated technology training, to ensure deep collaboration throughout the process while the CRO develops the expertise to manage more of the revenue-generating services.

Generating Revenue

Working with a technology partner to offer an ePRO solution enables CROs to reduce costs, accelerate study startup, develop an additional revenue stream, and maintain complete control over the ePRO deployment. One key success factor is selecting a partner that offers a cloud-based, fit-for-purpose, UX-friendly technology that provides competitive benefits in the market. The CRO must also make sure the vendor provides fully-functional support services, such as assessment licensing, software implementation, and training.

When managing the technology transfer, it’s a good idea to deploy via a closely-managed, staged process customized to the CRO’s internal capabilities and resources. Such a program should offer in-depth technology training to enable nimble, dynamic clinical study configuration. It should also prepare the CRO commercial team to assess and quote new business opportunities.

In one example model, the ePRO vendor initially performs the work while training the CRO team. As the CRO shadows the vendor team and learns more, it will gradually assume more responsibilities based on its internal capabilities and resources to manage the entire end-to-end process. The well-trained CRO will then license the technology and offer ePRO implementation, deployment, and support services in its portfolio.

Conclusion

ePRO technologies address some of the most pressing patient-centric clinical trial study needs in the industry. It’s important that CROs find a way to use these tools efficiently. Now is the time for CROs to look ahead and consider the benefits of a partnership that supports adding this important technology solution to their service offerings.

Clinical ink offers a Partner Program which enables CROs to deploy fit-for-purpose technology solutions that provide best-in-class patient data collection in clinical trials.

To learn more, view our Partner Program Fact Sheet, or contact us.

The post How Advanced Data Collection Technologies Enable CROs to Expand Their Service Offerings appeared first on Clinical ink.

Horsham, Pa.; September 14 , 2022 — Today Clinical ink, a global life science company, announces the launch of its new, configurable electronic clinical outcomes assessment (eCOA) technology. Powered by outcomes science expertise across multiple therapeutic areas, new and enhanced Clinical ink eCOA technology ensures faster study deployment and superior data quality, as well as better patient engagement and compliance, across all degrees of protocol endpoint complexity.

Often time-consuming and dependent on rigorous development, traditional eCOA platforms or applications are known to take extensive time and underperform—causing patients to drop out of clinical studies, costly data reconciliation, and delayed Sponsor timelines. The industry sorely needs a smarter eCOA that can reduce patient and site burden as well as accelerate therapy validation.

Clinical ink’s enhanced eCOA technology was designed to meet these challenges. It ensures speed via a 100% configurable activity designer, coupled with easy-to-use study build tools. The designer includes a drag-and-drop interface to advance the customization of complex eCOA activities, based off an extensive eCOA library that includes translations and data mappings. Better, it allows a real-time preview, ensuring an expedited build, as well as a more accessible experience by incorporating live translation manager tools and facilitating real-time translation—all possible through a single click.

This enhanced eCOA functionality is notably available via technology empowerment, a subscription license-based model that allows Clinical ink partners to “do it themselves” by configuring site and patient-friendly eCOAs without the need for complex development or extensive back and forth. Adding to this increased functionality, the enhanced Clinical ink eCOA technology further powers patient outcomes by ensuring BYOD deployment compatibility, customized and interactive patient alerts, and secure, personalized resources via a patient portal.

“At Clinical ink, we believe that consistency, reliability, and speed are critical to a successful eCOA platform. Customers want to be assured that the technology they deploy is true to sale, trustworthy, and will meet their study timelines.” says Lane Nichols, Executive Vice President, Head of Product at Clinical ink. “By applying years of clinical research, patient science expertise, and eCOA application design, Clinical ink has built a better way to accelerate eCOAs. We are dedicated to pioneering eCOA technology—consistently delivering a faster, smarter, and more reliable solution.”

About Clinical ink

Clinical ink is the global life science company that brings data, technology, and patient science together. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancements, drive the industry standard for data precision and usher in a new generation of clinical trials. By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience.

The post Clinical ink Debuts the Industry’s Smartest eCOA technology appeared first on Clinical ink.

The true hard and hidden cost of paper diaries

The cost of paper itself and of printing and binding diaries isn’t high. It’s what happens after the printing that becomes an issue. A paper-based data-collection process racks up hard costs and hidden costs at every turn. Let’s put aside the cost of the potential detrimental effects on data quality and look just at the calculable cost of paper’s burden to sites and sponsors.  A short list of the work required only when paper diaries are used includes:

• Preparing and distributing patient packets/subject binders
• Transcription of diary entries into the Electronic Data Capture (EDC) system, which typically  entails deciphering handwriting and addressing missing data
• Measuring patients’ visual analog scales (VAS) by hand 
• Source data verification (SDV)
• Data reconciliation
• Archiving hard-copy documents for 15 years or more, depending on the country’s regulations

The total costs of an eCOA system

On the flip side, using an eCOA, such as a patient reported outcomes (ePRO) tool, with an eDiary in clinical trials incurs costs for:

• Device provisioning, except with a bring-your-own-device (BYOD) study
• Software implementation and database programming
• Site- and study-level monitoring of patient engagement and compliance
• Software license fees

How paper diaries and eCOA compare

How do the two approaches compare in terms of cost? At Clinical ink, we not only offer a variety of digital clinical outcome solutions; we’ve also built a calculator that accounts for the costs associated with paper-based diaries vs. eDiaries from study set-up and maintenance through to database lock. In running the calculator on a number of studies with different parameters, we’ve found that using paper diaries is 30 percent to 50 percent more expensive than using eDiaries for patient reported outcomes. In one of our sample analyses, the sponsor saved $2 million by using an eDiary over a paper one.

More details on our calculator (how it works and what factors it considers) will be forthcoming, but we wanted to share the bottom-line results: it’s a false economy to use paper diaries over e-diaries. When patient-reported outcomes are included in a clinical trial, sponsors can save millions in hard costs by using an electronic source.. 

Find out more about how you can save using eCOA

If you are interested in our calculator’s findings for a proposed study of your own, please contact us.

Author: Rinah Yamamoto, Ph.D., Principal Scientist, Clinical ink

The post The False Economy of Paper Diaries in Clinical Trials appeared first on Clinical ink.

The accelerating complexity of gastroenterology protocols has exceeded the capacity of most electronic clinical outcome assessments (eCOAs) — including both electronic patient-reported outcomes (ePROs) and clinician-reported outcomes (ClinROs) — to adapt. Patients are overwhelmed, sites are overburdened, and Sponsors struggle with data quality and integrity.

At Clinical ink, we offer a better path–one that brings data, technology, and patient science together. We’ve spent years designing our GI eCOA library. Deployed and customized on demand, our technology integrates ePRO/patient engagement solution for patients at home, a full-service site tablet for ClinROs and PROs collected at visits, and an intuitive reporting portal for remote monitoring and data surveillance providing complete healthcare system integration. 

Clinical ink Knows the Typical GI eCOA/ePRO Requirements (and Stumbling Blocks)

Data collection for the GI therapeutic area is known to be particularly complex, with on-site questionnaires for both patients and clinicians, plus extensive patient input at home. Eligibility decisions are commonly based on data from all these sources and derived through complex calculations based on compliance. Data quality also depends on verified patient compliance. The challenge is to simplify the recording of all this data, ensure patients do what they need to and stay motivated, and make the information easily accessible to support trial decisions. Fundamentally:

1. GI patient burden is real

Staying motivated to complete the detailed, high-volume, schedule-and-event-driven diaries is a huge hurdle for GI patients. To address this challenge Clinical ink includes a full-scale patient engagement strategy in our ePRO application.

2. Site-based questionnaires can be a chore

Clinical ink questionnaires are purposefully clear and intuitive, requiring the least possible intervention by site personnel.

3. Clinicians must review disparate data to complete questionnaires

Clinical ink automatically integrates data into a tablet-based ClinRO workflow to simplify the site staff and clinician experience.

4. Strict patient compliance must be verified by site staff

When ePRO data represents the primary efficacy data, questionnaire completion is critical. Clinical ink ePRO technology automatically reports on screening criteria compliance and executes any necessary calculations, saving site staff and clinicians from having to determine these results — such as eligibility scores — manually.

Data Access in Real-Time Allows Clinicians and Sponsors to Monitor and Support

Data outputs, such as eligibility criteria and average daily pain, are summarized into summary reports that site users, clinicians, and Sponsors can access in near real-time. These reports eliminate the need to seek out disparate sources to make randomization decisions related to ePRO criteria.

Enhanced Functionality Reduces Build Times, Improves User Experience

Clinical ink’s proprietary eCOA authoring tool supports agile design and a collaborative build process. Iterative, prototype-driven design allows study teams to rapidly create highly functional applications. Lengthy build times and stressful review cycles — commonplace for GI trials — are avoided, while Sponsors gain confidence in overall study success.

Real-Time Alerts Ensure Compliance as Part of a Robust Patient Engagement Strategy

Beyond reporting, summary alerts notify site and study staff when patients exceed acceptable thresholds for compliance. Alerts are deployed as part of an outreach to support patients at risk of becoming non-compliant. This approach can increase the chances that subjects will remain eligible, even with the stringent compliance requirements.

Once patients are enrolled, the challenge becomes to keep them engaged, adherent to their visit schedules, and compliant with their questionnaires. At Clinical ink we’ve developed a completely unified patient engagement and ePRO experience, whether on provisioned or BYOD devices. This dynamic patient engagement solution is mobile-optimized, content-rich, image-driven, and targeted to drive key, critical behaviors and provide necessary study information at crucial moments.

Sponsor, Site, and Patient Burden Summary

Key GI ePro/eCOA Study Challenge

Sponsors	Sites	Patients
Lengthy/Complex Requirements	Patient Training	Daily Questionnaires
Confusing UAT	Complex Eligibility	Event/Episodic Questionaires
Time to Go-Live	Compliance Monitoring	Event Criteria
Reporting	Inventory	Event History
Data Delivering	Reporting	Visit Schedule
Data Quality	Data Quality	Visit Activity

 A Better Experience for Patients, Sponsors, and Clinicians with eCOA and ePRO

Conducting gastroenterology clinical trials in the same way over and over simply because it’s the way it’s been done before doesn’t work for indications as complex as GI. Our innovative technology is your GPS to high-quality data. However complex the protocol, Clinical ink technology helps ensure that the patient, study team, and site feels in control, regardless of whether you intend to publish a case study on gastrointestinal diseases.  Contact us to find out more about how we can help you.

The post Handling Complexity in GI Trials ⁠— a Purpose-Built eCOA/ePRO Solution: The GI Library appeared first on Clinical ink.

However, technology in cancer research and treatment has made incredible leaps in the digital age. With the growth in clinical research digital technologies, electronic PRO (ePRO) is rapidly becoming the standard across the clinical research industry because of increased ease of use, better data quality, and real-time access to site and patient data for remote monitors and Sponsors. Learn more about what makes this clinical research technology so useful for oncology trials.

What Makes ePRO Valuable for Patients in Oncology Trials?

1. Oncology patients have lots to report

What do surgery, chemotherapy, radiation, and hormonal therapy have in common? Side effects. Add in the symptoms of the cancer itself, and patients have a lot to talk about. While survival remains the most frequently used measure of clinical benefit for most cancer treatments, ePRO measures convey important information about the overall patient burden, effectiveness of treatments, and quality of life.

2. Regulatory agencies support bringing the patient’s perspective into cancer decision-making

As far back as 2015, the FDA conducted 24 disease-specific Patient-Focused Drug Development (PFDD) meetings to gather patients’ perspectives — including those from oncology patients. Since then, the agency has continued to promote efforts to gather information directly from the patient, especially through cost-effective and efficient means like ePRO.

3. ePRO offers a more patient-centric experience

Unlike paper-based PRO measurements, ePRO facilitates more quality time between patients and health care professionals by easing both site and patient burdens. For in-person and remote clinical trials, easy-to-use apps enable patients to enter information without cumbersome selections and workflows, either in the clinic or at home. This is great for oncology patients who already face a high burden of disease and associated treatment regimens.

4. Greater engagement puts patients at ease

ePRO technology can now help to guide the patient through required diary and questionnaire activities using conditional reminders and alerts, daily schedules, and task trackers. IT can also offer the patient resources like content libraries of useful study-related information, clinic contact information, and visit-by-visit preparation instructions.

5. Fewer visits mean broader access

Clinical trial participation can be cumbersome and expensive for patients who don’t live near major medical centers. ePRO technology enables access to more oncology patients from a more diverse cohort in rural, remote, or international locations.

6. Better monitoring can lead to improved outcomes

Unlike paper-based methods, ePRO tools enable real-time monitoring, allowing teams to respond more quickly and provide better care sooner. Research evidence suggests oncology patient outcomes may improve due to more timely site notifications of worsening symptoms, allowing physicians to take appropriate action.

What makes ePRO Especially Valuable for Sites in Oncology Trials?

1. During site visits, ePRO frees up staff

In clinical research for oncology studies, ePRO is typically collected during site visits. Technology can be deployed to walk the patients through the questionnaire, lessening site burden, increasing patient centricity, and eliminating the need for site staff intervention.

2. Better patient engagement in clinical trials leads to better protocol compliance

The benefits of patient engagement are numerous, with one of the key advantages being better protocol compliance. Automated reminders and notifications to the patients of tasks due improve patient adherence while saving the research coordinator’s time. Automated email notifications to the coordinator draw attention to any compliance issues early so they can be addressed. Better compliance means more complete, accurate data for more reliable results. 

3. ePRO leads to improved data quality

Paper-based PRO necessitates inefficient, manual data entry and duplicate storage. These data are often incomplete, nearly impossible to validate for timelines, and do not readily support audit trails. ePRO:

• Eliminates the need for data transcription and its potential risk of error,
• Streamlines and automates data entry and checking processes,
• Ensures timely and complete data entry with full attribution, and
• Enables health care professionals to focus on evaluating responses rather than entering them.

4. Real-time access to data improves safety and compliance

With Clinical ink, data is immediately available through the portal for monitoring and reporting, including complete visibility of patient status. This real-time monitoring is especially critical with oncology patients when quick medical response is warranted. 

Stronger Connections, Better Research, and Greater Care in Oncology Trials

By enabling an agile ePRO study design, better connections can be forged between oncology patients, sites, Sponsors, and CROs. It also means that oncology studies can start faster while simultaneously lowering patient burden. Patients and sites can switch back and forth among phone, web, or tablet — at virtual visits or physical sites — as desired, improving the results of clinical research on oncology.  Contact us to find out more about how we can help you.

The post ePRO Eliminates Barriers to Cancer Research appeared first on Clinical ink.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 85% of Americans own a smartphone, why not use the device they already know and love?

Smartphones are central to patients’ lives. Roll these devices into your trial for a better, patient-centric solution. BYOD, or Bring Your Own Device, is a viable option for many clinical trials and a must for decentralized clinical trials. While decentralized trial models and ePRO are both accepted in the industry, some Sponsors have hesitated on BYOD due to questions over data quality, integrity, variability, regulatory acceptance, and logistical issues.

The upheaval in clinical research caused by COVID-19 has prompted Sponsors and CROs to give BYOD a longer look. Patients are less willing to travel to physical sites and more comfortable using their mobile devices in the context of healthcare. To encourage enrollment, Sponsors must meet patients where they are: at home, on the go, or at the clinic.

With the FDA encouraging adoption of patient-centric approaches, clinical trial models that allow patients to report outcomes from home are the way forward. BYOD is a key component of this approach.

BYOD Benefits for Patients, Sponsors, and CROs

An increasing number of studies are deploying BYOD models with success, proving regulatory hurdles can be cleared. And the benefits to both patients and Sponsors make BYOD a clear choice for many clinical trials.

The biggest benefit? Patients prefer it. The more patient-centric your approach and the more seamlessly your clinical trial fits into your patient’s life, the more likely your patient is to stay engaged. They don’t have to learn how to use a new device, nor do they have to keep up with a second phone. Think about it: Most smartphone users can’t part with their devices for five minutes. But if they left a provisioned device at the office, it would prompt much less urgency. “I’ll enter my symptom info later,” they’d think. Not good for data accuracy.

A 2018 study explored patients’ preferences for paper-based and digital PROs. Patients completed a PRO using paper, a provisioned device, and an app installed on their mobile device. Patients later filled out a questionnaire about their attitudes toward each method.

Of the 155 participants, 94% said they would “definitely” or “probably” download an app onto their mobile device for a future clinical trial. A total of 45% thought BYOD would be more convenient. Only 15% preferred a provisioned device.

94% said they would “definitely” or “probably” download an app onto their mobile device for a future clinical trial.

BYOD also paves the way for compliance. In an early Clinical ink case study, patients leveraged the BYOD implementation twice as often and for twice as long (see below). This suggests patients were using the app as intended, which leads to better data and a smoother clinical trial.

Total App Sessions During the Study by Study Participant

Duration of Total App Use by Study Participant

Clinical trial Sponsors and CROs face enormous pressure to control costs and shorten timelines. BYOD helps achieve both. In addition to improving efficiency, BYOD significantly lessens — and perhaps eliminates — costs associated with data plans, shipping, lost or unreturned devices, and the overall logistics of inventory management. For a large trial, these savings could mean hundreds of thousands of dollars.

Dispelling the Myths

Myth #1: FDA Won’t Accept BYOD Data

While the FDA has not given explicit guidance around BYOD data, multiple studies have made regulatory submissions using BYOD-captured primary endpoint data. Concerning PRO assessments, in its COVID-19 guidance document, the FDA states:

“To mitigate the potential for missing data, Sponsors should consider remote electronic capture of these assessments through technologies that can remind trial participants to complete the questionnaires and/or verbal administration at the time instructed (assuming appropriate steps are taken to minimize bias from verbal administration).”

This statement indicates an acceptance of mobile devices generally. However, Sponsors must accommodate patients who don’t have a mobile device or who don’t want to use their device.

We’ve found the FDA is willing to have conversations about BYOD on a study-by-study level. And given the agency’s push to move away from paper-based trials, it’s likely the FDA would look favorably on a trial deploying BYOD for ePRO.

Engage with the FDA early in your protocol to get feedback regarding BYOD or a hybrid strategy. Depending on protocol requirements and indications, an ePRO vendor should be able to offer hardware and implementation recommendations for your study.

Myth #2: BYOD Raises Copyright Issues

PRO questionnaire copyright holders may have reservations about the use of their work in an instrument (like a mobile app) that they haven’t reviewed. Any approach for BYOD should be reviewed and approved by the copyright holders before ePRO development begins. If that’s not an option, BYOD may not be the best choice. If the copyright holder has expressed comfort with BYOD or if the questionnaire was created by the Sponsor or CRO, you’ve got the green light for BYOD.

As you plan ePRO development, raise any copyright concerns with your vendor. They may have relationships that can help facilitate the process.

Myth #3: BYOD Leads to Inequivalent Data

Multiple studies and meta-analyses show high levels of agreement between paper and electronic formats. If you follow general principles of ePRO design good practices — such as those reported by Critical Path Institute’s ePRO Consortium — measurement capabilities between paper-based data collection and mobile devices should be equivalent.

Clinical ink’s ePRO technology provides consistency whether patients use their smartphones, provisioned devices, or a combination. An internal study found no statistically significant difference in implementations between provisioned hardware and patient smartphones.

The BYOD Bottom Line

BYOD is an important component of patient-centricity in clinical trials. The approach doesn’t suit every trial — some may require a hybrid approach while others may require provisioned devices exclusively. To determine whether BYOD is right for your or your client’s trial, consult with a BYOD-experienced vendor to evaluate risks and opportunities and determine the best path forward. 

Tip: ask about regulatory and copyright requirements.

Bring Clinical ink’s expertise into your BYOD study

At Clinical ink, our experts can help you determine how BYOD fits into your decentralized or traditional trial. Whether you choose provisioned devices, BYOD, or both, our patient engagement, design, implementation, translation, and licensing experts are there to help you every step of the way.

Empowered patients lead to better outcomes. Whether you’re a biotech startup, a global CRO, or an established pharmaceutical company, consider BYOD as a vehicle to improve data quality, save time and money, and to win high marks from your study participants. Contact us to find out more about how we can help you.

The post Go Where Your Patients Are: Launch a Successful Bring Your Own Device (BYOD) Study appeared first on Clinical ink.

Horsham, Pa.; May 18, 2021 – Clinical Ink, a global clinical trial technology company, today announced the hiring of Janette Morgan as EVP, General Manager, EMEA. In this unique, hybrid role, Janette will manage the company’s dramatic global growth, blending a focus on both commercial and study operations, while building out an international team to support Clinical Ink’s customers.

“Clinical Ink is hyper-focused on delivering results for our customers,” said Clinical Ink CEO Ed Seguine. “While our primary competitors are focused on concocting their next stage of funding, Clinical Ink is hiring the best people in the industry to better deliver for our customers. As a profitable, mature company and undisputed eSource leader, we are building out our global customer support infrastructure to ensure our explosive growth does not outstrip our ability to provide unparalleled customer service. Janette brings tremendous expertise to our executive team and is the right person to build out our international operations.”

“I believe Clinical Ink’s technology platform and service-first approach will solve the industry’s biggest problems now and into the future,” said Janette. “I’m excited to ensure our customers have solutions to the dynamic clinical and operational challenges that have afflicted this industry for so long. Joining Clinical Ink is an expression of my optimism about the future and I look forward to collaborating and partnering with our customers to confidently address the great potential for technology to improve the clinical trial experience for patients and sites.”

Prior to joining Clinical Ink, Janette was at Medidata Solutions for 13 years in a variety of roles, and worked for a number of eCOA technology providers in the earlier part of her career. Most recently, she was Vice President, Global Partner Initiatives & Partner Business Management, where she was responsible for the global leadership and management of Medidata’s Partner Study-by-Study Business. Working with CRO partners on a global scale from proposal through to contract execution, Janette was instrumental in the transformation of strategy, processes, and GTM approach to address the needs of the most demanding pharma and biotech customers.

Clinical Ink’s Lunexis platform collects clinical trial data from patients and clinicians, at home and on-site. In the past three years, project bookings have tripled, revenue more than quadrupled, and backlog has grown by 500%. Clinical Ink has conducted hundreds of clinical trials on the Lunexis decentralized trial platform, capturing data from patients where they live — everywhere from villages in West Africa, mountaintops in Nepal, nursing homes in Europe, and patient homes in 60+ countries. Lunexis began as a way to transition sites from EDC to DDC (eSource) and to enable easier patient participation at home with BYOD ePRO+. It now offers Build Your Own Study capabilities for sponsors and CROs to have greater control over study design and execution.

About Clinical Ink
Clinical Ink, a global clinical technology company, offers data certainty from source to submission via our Lunexis eSource clinical technology and configurable direct data capture, eCOA, ePRO, and eConsent modules. This suite of solutions for capturing and integrating electronic data from sites, clinicians, and patients at its source naturally enhances clinical trial workflows. For virtual, traditional, or hybrid trials, Lunexis technology reduces manual labor and provides anytime, anywhere data access, saving resources as your trials progress.

The post Clinical Ink Hires Industry Veteran Janette Morgan as General Manager, EMEA appeared first on Clinical ink.

Clinical Ink’s complex eCOA scales and assessments solutions include the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Vineland-3, Bayley-III, and others that have never been implemented effectively in an electronic format. Lunexis supports administering complex rating instruments and enables audio and video (A/V) collection that facilitate rater review to ensure inter- and intra-rater reliability.

“A significant share of the clinical trials industry is still relying on paper and pencil cognitive tests when electronic versions are available — versions that support not only better data quality but reduced timelines and cost,” said Clinical Ink CEO Ed Seguine. “Our complex eCOA scales and assessment implementations represent a new standard of trial execution simplicity and efficiency.”

A neuropsychologist with firsthand experience with Clinical Ink’s customized complex scales and assessments recently stated, “This project was a huge undertaking, and I was sure I was going to find at least a couple errors in that data generated by Clinical Ink’s eCOA. There were no errors. They eliminated the inevitable human errors that occur when using traditional solutions requiring transcription and manual grading.”

Clinical Ink implements and deploys clinician reported scales and assessments for even the most complex eCOA solutions, streamlining work flows and producing clean, complete data for challenging studies. Clinical Ink’s real-time prompts and edit checks help provide complete data sets, from which complex scoring can be generated automatically. Data can be monitored as it comes in and queried as appropriate.

About Clinical Ink
Clinical Ink, a global clinical technology company, offers data certainty from source to submission via our Lunexis eSource clinical technology and configurable direct data capture, eCOA, ePRO, and eConsent modules. This suite of solutions for capturing and integrating electronic data from sites, clinicians, and patients at its source naturally enhances clinical trial workflows. For virtual, traditional, or hybrid trials, Lunexis technology reduces manual labor and provides anytime, anywhere data access, saving resources as your trials progress.

The post Clinical Ink Deploys eCOA Solutions for Industry’s Most-Complex Assessments 500 Unique Scales and Assessments in 82 Languages appeared first on Clinical ink.