At the heart of EOM is a patient-centered approach that considers the unique needs of oncology patients. By providing better support, improving patients’ comprehension of diagnosis and prognosis, and enabling them to adhere to their treatment plan, EOM seeks to enhance patients’ care experience. Key to its success is the redesign of activities and the implementation of patient-focused technology, including electronic patient-reported outcomes (ePROs) and health-focused social screening tools. This technology provides valuable data for better decision-making in treatment, as well as increasing patient and caregiver satisfaction.

How will oncology patients benefit from this patient-centric, clinician and technology-driven EOM?

• EOM puts the patient at the center of a care team that provides equitable, high-value, evidence-based care
   
• Patients will have 24/7 access to care, patient navigation, and care planning
   
• EOM increases engagement of patients, oncologists, and other payers in value-based care and quality improvement
   
• Improved care quality, health equity, and health outcomes can be observed, while achieving savings over the course of the model test

By leveraging the benefits of EOM, oncology care can be delivered more efficiently and effectively.

The success of EOM will depend in part on the effective integration of technology. Solutions like Clinical ink ePRO provide a simple and intuitive interface for patients who are already overwhelmed from both disease and treatments, while streamlining the data collection process for physicians and oncology practices offers reliability and accuracy to improve overall patient outcomes.

It is clear that patient-centered care is at the forefront of the oncology community, and the EOM is just one example of this shift in focus. For sponsors and CROs, it is critical to adopt a similar patient-centric approach when designing oncology studies. By considering the unique needs of oncology patients and leveraging technologies like Clinical ink eSource, sponsors and CROs can improve patient experience and safety, clinical data quality and integrity, and the efficiency of healthcare providers and study teams.

To learn more about Clinical ink patient-centered solutions that align with the goals of EOM, download our factsheet Eliminate Barriers to Cancer Research with Clinical ink ePRO or speak to an expert to see how we can help.

The post Enhancing Oncology Model (EOM): A Patient-Centered Approach to Transforming Cancer Care Delivery appeared first on Clinical ink.

Sponsors considering using data from sensors and wearables in their clinical trials worry about three scenarios: collecting too little data, collecting too much data, and collecting bad data.

Each outcome could likely impact their study or a portion of it with a significant waste of time, money, and patient goodwill.

How can you de-risk the use of directly captured data from patients? How can you ensure that incoming data is properly ingested, stored, consumed, and managed to avoid potential issues?

Consider the specialized expertise required to integrate the right data collection application—a unified data platform—and the most advanced analytical methodologies.

Here is some insight from the Clinical ink Advanced Technology Team:

Solving “Too Little Data”

Sponsors may end up with too little data and insufficient statistical power when a protocol is too taxing for patients. Recruitment falters and adherence drops off. Getting expert consultation on protocol design provides an early and thorough assessment of all the abilities and limitations of the target patient profile.

Understanding patient insights and the use of patient-centered measures and assessments guides the technology strategy that will help prevent situations leading to “too little data.”

Clinical ink on Solving “Too Little Data”

In one assessment, recommendation against requiring prospective participants to complete a nearly 100-question survey at the start of the study could prevent loss of participation.

Evaluation concluded the process represented a burden that the particular patient population may not overcome.

Managing “Too Much Data”

Can you ever really have too much data? Maybe not, but wearables and sensors generate colossal and continuous streams of data. You can have more data than a particular system can handle or analysts can interpret.

The Clinical ink solution involves using a data platform that can store, process, and analyze any type and volume of data associated such as patient cognition, mobility, and phonation. Technology led by an expert analyst team converts incoming raw data into file formats — and ultimately dashboards — that Sponsors can easily consume (See Fig. 1).

Clinical ink on Managing “Too Much Data”

For instance, one assessment used in studies in Parkinson’s disease and COVID is a verbal phonation exercise in which the patient is asked to sustain a certain sound (such as “ah”). The incoming data is binary — a series of ones and zeros — and readable only by machines.

Converted into human-readable files that contain variables enables data scientists to screen important data for analysis. Getting reports and visualizations for data analysts to query the data is crucial in detecting signal patterns and drawing conclusions.

 

Preventing “Poor Quality Data”

Ensuring that the data collected from sensors and wearables is clean and usable requires a deep understanding of the therapeutic area, a detailed knowledge of industry standards, cutting-edge research analytical practices, and a patient-centered approach.

To ensure that collected data is of the highest integrity, here are few rules:

 

• • Rely on applications and tools that have been evaluated for that specific research purpose. In any therapy area, leverage industry standards and consult with experienced research leaders to determine what signals will be most meaningful.
     

• • Apply patient science, using qualitative and quantitative data collection methods, to ensure that the research approach is centered around the patient rather than the technology.
     

• • Design applications to create an excellent user experience that encourages adherence to the protocol and minimizes the opportunity for “user error.”
     

• • Clean and filter data, at the individual patient level, to maximize usability and efficacy for data analysis and modeling.
     

• • Consult your own quality control dashboards as data points come in and at the conclusion of studies to continuously improve methodologies.
     

Concerns over volume and quality of data generated in a trial are natural and should always be discussed as potential risks. Consider overcoming these challenges as fundamental to the success of any study — particularly those using eSource and more complex streams of patient data gathered from sensors and wearables.

To learn more about how Advanced Technology Teams in our industry operate, and how they prepare some of the most complex datasets for analysis, read “Debunking Complex Data Preparation and Analysis.”

Author

Anna Keil
Senior Software Engineer, Clinical ink

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The post The Three Perils of Wearable Data appeared first on Clinical ink.

We all benefit from many technological advances—from GPS to AI/ML to ChatGPT—without questioning exactly how they work. There’s no real need to understand what goes on “behind the curtain” or “under the hood.” The focus is on what is created over how output and results are created.

When it comes to data capture from mobile devices in clinical trials using eSource, clinical ops and study managers must have a deep understanding and control over the “how”: how study data is generated; how work being done behind the scenes is ensuring the right data is captured, ready, and available for analysis.

Why? Because with any mistake made—should the wrong signals be measured or should the data capture methodology be too burdensome for patients—the data may be compromised and have limited value at the end of the trial. It is essential to not only engage with the right data team, but more importantly to understand how they leverage technology to capture and analyze data accurately.

For every trial that uses complex eSource data, in particular data coming from mobile devices and technology, including sensors and wearables, Clinical ink assigns an Advanced Technology Team to ensure that the most meaningful measures are taken, the data properly prepared for analysis, and the needed infrastructure provided to support that analysis.

Data engineers and data scientists provide the expertise in programming, data management, and statistical modeling, and also most critically in user experience (UX) design. Their knowledge of the human factors is critical to the quality and integrity of data collected electronically.

Here are ways to ensure success collecting complex eSource data in clinical trials:

1. Involve clinical specialists and human science experts to consult on protocol design early. Ensure that the data collected will support the research goals and that the study design will not inhibit patients’ participation, adherence, or retention in the study.
    
2. Rely on UX experts as the interface between humans and machines to support better experience and good science, and ultimately deliver valid results. Leverage their knowledge of how humans behave and how the data collection must work to get consistent amounts of clean data.
    
3. Create a Data Dictionary with data scientists based on the protocol to define what data will be collected considering all possible variables, ranges for each value, and data schema for the database. Coordinating input from and agreement between the Sponsor, the Contract Research Organization (CRO), and the Clinical ink application development, platform, and data teams is critical.
   
   The Data Dictionary determines what assessments will be created in the electronic device, how the data lake will be structured to support analyses, and what visualizations will be required to interpret the data. The Data Dictionary clarifies what exactly will be delivered.
    
4. Develop the infrastructure with engineers to pipe the data into a data lake, which will house the raw data in a way that will facilitate easy access and analysis by data scientists and data analysts. They develop, refine, and provide the tools to perform machine learning on the data and populate dashboards in real time.
    
5. Build and test dashboards with data scientists and data analysts that will display data for real-time monitoring of protocol adherence and data quality.
    
6. Feature engineering pipelines and train advanced machine-learning models with data scientists and statisticians to support real-time predictive analytics. Such analytics can be used to predict a patient’s adherence to the study protocol or disease status.

The Clinical ink Advanced Technology Team is a learning organization. This means that they adopt the learnings from one project to inform the next study design. They use the feedback from post-study analyses to continuously hone their skills.

The Clinical ink Advanced Technology Team helps you understand and prepare how to process complex eSource data, so you can be an effective decision maker in ensuring that the technologies, methodologies, and deliverables around eSource data will meet your study goals.

Read more about the Clinical ink Advanced Technology Team and its goals in this DPHARM interview with Joan Severson, Chief Innovation Officer and team lead.
 

The post Debunking Complex Data Preparation and Analysis appeared first on Clinical ink.

Most clinical trial data can now be collected directly and automatically — at the moment of inception — without the need to transcribe and verify source records or integrate software. This direct-to-database model is far simpler, faster, cleaner, and compliant than paper-based methods. And, with the right eSource platform, trial data can be aggregated, integrated, and classified to accelerate data analysis for insight-based decisions in real time.

Direct Data Capture: What’s Not to Like?

Direct Data Capture (DDC) technology ingests trial and patient source data captured directly at the source. The speed and directness of eSource data offers a number of advantages to Sponsors over traditional paper-based methods of recording trial data and even over limited-use electronic data capture (EDC) systems. Foremost among these are:

• Improved study oversight.  With role-based visibility to data in real time, study teams can intervene as needed to reduce risks and monitor patient progress in a timely fashion.
   
• Greater control over protocol execution. eSource technology provides automatic calculations and includes instructions to reduce errors. Guided information entry protects against protocol deviations, ultimately reducing the number of data queries.
   
• Accelerated decision making. There is no lag time since eSource data doesn’t need to be transcribed, loaded, verified, and integrated.
   
• Higher quality data. With Direct Data Capture technology, there’s less room for human error. There is no transcription. No patient diaries hurriedly completed in the clinic parking lot. No errors or omissions in visit records. The technology flags missing, erroneous, or inconsistent data based on pre-determined logic.
   
• Use of digital biomarkers. With advances in wearable and sensor technologies, state-of-the art instruments specific to a therapeutic area can be developed to complement existing assessments and augment traditional clinical trial data. Our work to date has demonstrated that mobile devices can be easy for patients to use, secure, and valuable in detecting disease and tracking patients’ ongoing status. In time, we believe that they will be used in conjunction with other scales to determine an individual’s disease probability, severity, and risk for progression, with applications in clinical trials as well as medical practice.
   
• Time and cost savings. When data are captured electronically from the source, there is no need for it to be transcribed into a software program nor is there any need for Source Data Verification (SDV). Plus, the process generates fewer data queries and streamlines the query management process.

Naturally, clinical development, operations, and IT leaders seek to rationalize and optimize the mix of technology available to support their trials. Given the digitization of trial data, the ideal solution supports real-time data collection into a single eSource ecosystem that is scalable, sustainable, and customizable. 

To discuss how to leverage direct data capture for your clinical trials, talk to one of our experts or learn more about eSource Technology.

The post Straight from the Source: How Capturing Data Directly is Transforming Trials appeared first on Clinical ink.

By accommodating remote participation in trials, eSource solutions allow sites to better meet the new expectations for patient centricity. Sponsors who can deliver this have an advantage in attracting sites to participate in their trials.

What’s in it for Sites

Integrating Direct Data Capture (DDC) technology, electronic Clinical Outcome Assessments (eCOA), electronic Patient-Reported Outcomes (ePRO), and eConsent into a site’s workflow improves the capture, visibility, and management of data across devices, sensors, telemedicine, and digital health technologies. This proven approach eliminates many needs for heritage Electronic Data Capture (EDC) systems, which can be fraught with delays and data inaccuracies due to paper transactions, transcription errors, and Source Data Verification (SDV) processes.

For Sponsors to take full advantage of a single clinical data platform that supports end-to-end clinical development and clinical data capture, sites must adopt direct capture technology. Even sites hesitant to make this shift can recognize the value in doing so when they understand how it helps them serve their patients. Capturing data directly at the moment of inception helps sites by:

• Saving time. DDC technology allows clinicians to enter data into an electronic record during the patient visit, no matter where it takes place. Other electronic source data such as physician notes, drawings, audiovisual recordings, ECGs, and laboratory results can also be entered directly into the study database as part of the electronic research record. There’s no need to transcribe anything into the EDC, resulting in dramatically fewer queries.

As one site staff worker said, “Once we finish the patient visit, we’re done. There’s no further work. Clinical ink saved at least 30 percent of my time.”

• Improving patient safety. The study team gets a real-time view of all site-based eCOAs and other Case Report Form (CRF) information to support confident decision making and improve patient care. There is no lag time between the patient visit and the ability to monitor the data.
• Supporting protocol adherence. Direct Data Capture technology highlights data fields required by the protocol and/or regulatory guidance to ensure that records are complete. Being able to record data in real time — during the assessment — means that any questions can be addressed while the patient is present, mistakes can be caught before the patient leaves, and adequate documentation is ensured.
• Securing regulatory compliance. eSource technology protects data from its inception, reducing trial risk and making it easy to maintain a digital audit trail. This in turn facilitates success with New Drug Application (NDA) filings.
• Accommodating sites’ workflow needs. Sites don’t have to create their own source documents, and appreciate the way data capture tools simplify complex studies. The ideal solution is designed to mirror the flow of the patient visit, guiding the investigator through the completion of all necessary assessments and ensuring that the documentation required to support scores, and to answer any subsequent queries are captured while the patient is on site.

eSource technology, when delivered in a single clinical data platform, connects data and operations in a way that re-centers clinical trials on the patient for the good of all, including sites.

The post eSource Technology: An “Easy Sell” to Clinical Trial Sites appeared first on Clinical ink.

Fortunately, as Sponsors incorporate eSource technologies and decentralized data collection into their trials, these barriers to patient participation and adherence are beginning to fall away. Direct Data Capture (DDC) software can collect patient data at the instant they’re initially recorded in an electronic format—i.e., during telehealth visits, in electronic diaries and patient engagement platforms, and via sensors and wearables. 

In the broadest sense, eSource technologies allow Sponsors to center trials on patients and their needs as never before. This advancement of clinical trials can thus be based on comprehensive, actionable, patient-centered measures and assessments, or what Clinical ink calls “patient science.” With the right systems and tools, trials can collect comprehensive and actionable measures that meet research objectives, and therefore advance the pursuit of a treatment or cure. More specifically, with respect to trial participation, software and tools that allow data to be captured electronically give patients:

• Greater flexibility and convenience. When mobile devices are employed, data can be collected from anywhere (even when internet connectivity is temporarily unavailable), meaning that patients need not travel to the clinic for a growing number and type of assessments.  
• Increased safety. Wearables and sensors can track and report side effects continuously and automatically for immediate review by safety teams.  
• A stronger sense of involvement. Rather than being observed by a clinician during infrequent visits, patients are able to report their own feelings about their condition with greater frequency — an opportunity that they generally appreciate.

Other benefits accrue when eSource tools are designed with patient needs, abilities, and preferences in mind. The best solutions make patient participation easy and engaging by providing:

• Unobtrusive data collection. Many mobile devices, including sensors and wearables, fit seamlessly into patients’ daily lives, and data are collected passively and automatically as patients go about their day. Patients need not take any steps to comply with the data collection requirements.  
• Intuitive, approachable applications. When patient reporting tools are developed according to the best practices of user experience (UX) design, assessments are easy for the target patient population to complete. Design elements for electronic symptom diaries, for example, can include radio buttons, emojis, sliding scales, and questionnaires with built-in and transparent skip logic. Active assessments utilizing sensors and wearables, for instance on an Apple Watch, similarly engage patients with simple, guided, and easy-to-complete mobile activities. The best approaches are not coldly clinical in nature, but pleasant — and at times even fun — to complete.
    
• Simplified assessments. Patients (as well as clinicians) can more easily navigate complex protocols when measurements are focused on those that will get the best (most meaningful) signal, such as, for example, the BRACE (BrainBaseline Assessment of Cognition & Everyday Functioning) used to test patients’ cognitive and mental health. Dr. Rubin, an Associate Professor of Neurology, Psychiatry, and Epidemiology, says, “Being able to hand an iPad over and have [patients] complete the BRACE cognitive battery basically [takes] away all of the burden.”
    
• Easy instructions. We recommend creating video instructions for patients to help them complete assessments either at home or in the clinic. Clear, animated video clips are helpful, for instance, in demonstrating the steps a patient must take to complete cognitive, small motor, mobility, verbal articulation, and sustained phonation tests. Such instructional videos give patients confidence that they’re proceeding correctly, and ultimately improve the quality of the data.

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All of these innovations allow Sponsors to meet patients “where they’re at” — physically, cognitively, psychologically, and practically speaking. They enable patients, by leveraging technology as well as their own expertise, to fully participate in patient science. Patients are required to make fewer visits to the clinic and can provide their data either through completely passive means, or through active measures that are both easy and engaging. When eSource tools are properly designed and integrated into a trial’s protocol, they offer patients a seamless trial experience that is attentive to their needs, accommodates their limitations, and reinforces their commitment to the research.

The post eSource: Power to the Patient appeared first on Clinical ink.

However, how and where trials are conducted is changing, accelerated in part due to the COVID-19 pandemic. Trials have become more decentralized, and data can be collected in many different ways, from televisits to mobile devices, regardless of physical location—patients may not even need to be present at a physical clinical site. Increasingly, source data for clinical trials can include eConsent forms, patient reported outcomes (PRO), clinician reported outcomes (ClinROs), data from eDiaries; eCRFs completed during telehealth, in-home patient visits, or visits to remote medical locations; laboratory reports; imaging; and data from wearables and sensors.

One might assume that the “E” in EDC systems would apply to all of these sources, but it does not. At their core, EDC systems are simply a way for site staff to transcribe data from the patient visit into an electronic record rather than using a paper case report form (CRF). In many cases, a paper source document is still used to record data during the patient’s site visit. This process breaks down when the patient can’t or won’t come to the site.

The one-trick nature of EDCs is inadequate to support many trials, as without heavy, manual integration processes they lack the ability to capture data in real time, and often require patients to visit a research site. Fortunately, technologies exist to ingest electronic data from the various electronic sources, supporting virtual or hybrid studies. A purpose-built eSource solution from Clinical ink supports direct data capture from these many sources into its secure database, shared with the Sponsor, and can be used wherever the patient might be. This provides a comprehensive view of the patient in real time.

Such a system vastly improves the efficiency of capturing, recording, verifying, and sharing data in clinical trials. It reduces bottlenecks for assessments, makes it easy to remotely review source data, supports cleaner data upon entry (with real-time edit checks), and reduces data queries. All of this reduces patient and site burden while reducing both time and cost to the Sponsor, and accelerating database lock.

In one study that Clinical ink supported, for example, the protocol included a combination of on-site and home visits. While the baseline assessment and end-of-study assessments were performed at the site, all other assessments were conducted in the patient’s home via video conferencing. Investigators captured data from those visits, including video recordings, on their tablets and the data were uploaded to the Clinical ink secure, Sponsor-accessible database portal. The Sponsor thus had immediate access to validated data via a portal and there was no lag time between the patient visit and data visibility.

Additionally, it eliminated any reconciliation time over duplicative data sets (as is the case with paper source documents) as well as time for the transcription of source data into an EDC. This in turn reduces queries by Sponsor monitors and site staff, allowing for the real-time monitoring of trial progress and leading to cleaner data all around. Indeed, with Clinical ink eSource Direct Data Capture, the average query rate for entire studies is 0.23%, with an average response time of about one day. All in all, the average time to export data was 28 minutes, and the average database lock time after the last patient’s last visit was only 23 days.

The availability of eSource platforms to capture, integrate, and report on data collected from multiple sources gives Sponsors the ability to truly pursue decentralized study designs or to comprehensively incorporate decentralized elements into their hybrid trials. The utility of eSource platforms should not be confused with the much more limited purpose of some EDC systems where the source of the data remains the paper form completed during the site visit, and which often do not have the ability to capture in-clinic data in real time.

Discover more information on how Clinical ink eSource technology supports all trials—including in-clinic, remote, and hybrid.

Author

Rinah Yamamoto
Principal Scientist, Clinical ink

The post eSource: The Future of Real Time Data Capture and the Departure from EDC appeared first on Clinical ink.

HORSHAM, Pa.; May 4, 2021 – Clinical Ink, a global clinical trial technology company, today announced the hiring of CCO Chris Crucitti, COO Brian Donahue, and VP Project Operations Bill Barrasso. All three positions are newly created to help manage the unprecedented industry demand for the eSource leader’s eCOA, ePRO+, DDC, and eConsent platform.

“Clinical Ink pioneered the development of decentralized trials (eSource) long before the label even existed and we are responding to the tremendous growth opportunities ahead,” said Clinical Ink CEO, Ed Seguine. “This industry is plagued with visionary talk that so often lacks substance and comes up short in real-life. Adding these experienced industry veterans builds on the disciplined execution mindset we have cultivated over the years. These leaders bring great insight, expertise, and vision to our confident, reliable delivery of results in the most complex and demanding therapeutic areas.”

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.

Chris Crucitti, Chief Commercial Officer
Christopher L. Crucitti is a 20+ year life sciences and clinical services/technology executive. Prior to joining Clinical Ink, Chris most recently held the role of Chief Commercial Officer at Signant Health, where he led the commercial functions and go-to-market strategy. In addition, Chris brings significant experience and expertise in the clinical and R&D domains, including full-service CRO, data and analytics, eClinical technology solutions, strategic resourcing, and consulting.

“I am very excited to join Clinical Ink’s team of incredibly smart, passionate, and committed problem-solvers,” said Crucitti. “My primary goals are to solidify Clinical Ink’s customer-focused approach as we continue our rapid growth, to optimize an already high performing go-to-market strategy, and to build a trusted expertise-based partnership model with our customers. We will also continue to innovate, while demonstrating thought-leadership, to meet the critical goals and challenges of our customers in a quickly evolving clinical development landscape. Clinical Ink has quietly been involved in some of the most consequential clinical programs over the past several years and I look forward to the many opportunities to expedite the process of delivering meaningful treatments to the patients who need them.”

Brian Donahue, Chief Operating Officer
Prior to joining Clinical Ink, Brian held a variety of leadership roles at GE for 16 years. Brian started his career in GE’s world-renowned Operations Leadership Program. This led to multiple roles within GE Capital prior to his transition to GE Healthcare, where he served in multiple operational, commercial, and general management leadership positions in the U.S. and Canada.

“Leading Clinical Ink through its next phase of growth will require expanded operations functions with an emphasis on superior customer support across the organization,” said Donahue. “The ongoing support of our customer base and enhanced data reporting will be integral to customer satisfaction and retention, and I look forward to developing our strategy for shared services, project management, and operations functions across the business.”

Bill Barrasso, Vice President, Project Operations
Bill Barrasso brings a deep understanding of clinical trial processes and regulatory guidance required for successful study execution. Bill established the eCOA delivery services team at Parexel after leading eCOA services organizations at both ERT and PHT Corporation. Prior to that, he was the Director of Operations at Concordant Rater Systems (rater monitoring and eCOA data collection in CNS studies), which was acquired by United BioSource Corporation and spun off into Bracket.

“Global delivery processes, excellence in execution, and operational strategies for the delivery services organization will ensure Clinical Ink remains at the forefront of the eCOA/eSource/ Decentralized Trial transformation,” said Barrasso. “I look forward to driving study management processes that deliver high-quality and timely solutions to our valued clients.”

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, patients, and caregivers at its source naturally enhances clinical trial workflows. For virtual, traditional, or hybrid trials, Lunexis technology reduces manual labor and associated delays, and provides anytime, anywhere data access, saving resources as your trials progress. For more information, visit Clinical Ink.

The post Clinical Ink Hires CCO Chris Crucitti, COO Brian Donahue, VP Bill Barrasso appeared first on Clinical ink.

The EMA response was requested by Novartis Europharm Limited and cites data and insights gained from numerous Phase I, II, and III studies using Clinical ink’s eSource platform to provide real-world context for the business benefits and implementation use-cases of deploying eSource DDC in global studies.

The opinion concludes that eSource DDC, when implemented correctly, is GCP-compliant and can be used in support of regulatory filings. The regulators identified several critical differences in capturing source data electronically as opposed to simply implementing a traditional EDC system. This opinion also serves to eliminate the perceived uncertainty between the FDA’s previous endorsement of eSource. 

Notable metrics cited in the Novartis business case include:

• Time to data availability dropped six-fold.
• Number of data points that remained unchanged throughout the study increased 7%, indicating fewer changes because of data queries or monitoring.
• Time to resolve data queries dropped by more than half.

This and other evidence led the EMA to state in its opinion that, “eSource DDC has the potential to improve quality of data and lead to operational efficiencies.”

Regulatory endorsements of eSource technology from organizations like the FDA and EMA make it easier for sponsors and CROs to implement the kind of innovative technology that is revolutionizing the way clinical trials are conducted. As an industry pioneer, Clinical ink is lighting the way forward.

Find out how our technology brings you an integrated, convenient eSource solution that provides anytime, anywhere access to your study data. Clinical ink’s interconnected eSource ecosystem illuminates your data and empowers you to make well-informed, confident decisions.

The post EMA Greenlights eSource DDC and References Clinical ink appeared first on Clinical ink.

SAN FRANCISCO, CA & PHILADELPHIA, PA – May 18, 2017  Endpoint Clinical, the leading global interactive response technology (IRT) company, and Clinical ink, the pioneering provider of eSource and patient engagement technologies, have teamed up to integrate IRT and eSource in order to create a seamless user experience for investigator sites.

“The workload on investigator sites has steadily increased over the years; each technology advancement requires the site to learn new tools, remember more usernames and passwords, and work with yet another siloed data set for reporting” said Chuck Harris, CEO endpoint. “The endpoint-Clinical ink integration enables clinicians to focus their energy on what matters the most –  patient care.”

This collaboration between endpoint and Clinical ink integrates Clinical ink’s SureSource eSource platform and endpoint’s PULSE IRT.  Clinicians electronically record protocol required source data while accessing best-in-class IRT functionality to randomize patients and manage mission-critical clinical supply information through a single system during the patient visit.

“Clinical ink’s novel approach to capture clinical trial source data electronically during a patient visit coupled with endpoint’s IRT solution is a tremendous benefit for both sites and sponsors,” said Jonathan Andrus, COO Clinical ink.  “From the site perspective, it just made sense for us to collaborate – both the IRT and eSource system rely on the same patient data; our combined solution reduces the effort and risk of managing data across multiple platforms, helping to improve protocol execution.”

Otsuka Pharmaceuticals has provided critical support and guidance as this relationship evolved.  Their early adoption of eSource and vision of how other systems could be integrated created a lot of momentum for this ‘industry-first’ initiative.  “This effort not only improves the day-to-day operations and compliance of our clinical studies, but improves the speed with which we can obtain insights in to study data,” said Shashank Rohatagi, PhD, MBA, Leader, Data Sciences, Otsuka Pharmaceutical Development and Commercialization.  “In addition to reducing the burden on clinical site personnel, the ability to increasingly integrate our clinical trial systems is key to real time access and insights of our clinical trial data; something not feasible in the past.”

Combining eSource and IRT, benefits both sites and sponsors by simplifying the critical randomization and tedious supply accountability tasks that typically require so much time and effort.  Clinical ink and endpoint Clinical are committed to continuously improving the utility of this ‘industry-first’ alliance to reduce the burden on sites and improve data quality for sponsors.

About endpoint

endpoint is an interactive response technology (IRT®) systems and solutions provider that supports the life sciences industry. Since 2009, we have been working with a single vision in mind, to help sponsors and pharmaceutical companies achieve clinical trial success. Our solutions, realized through the proprietary PULSE® platform have proven to maximize the supply chain, minimize operational costs, and ensure timely and accurate patient dosing. endpoint is headquartered in San Francisco, California with a global footprint in the APAC region and Europe.

About Clinical ink

Clinical ink is a global clinical trial technology company that is transforming the clinical trial experience. Founded in 2007, the Company’s proven and future-built eSource platform, which includes solutions for EDC replacement, eCOA, ePRO and more, accelerates time to value while delivering scientific results that matter. With offices in Winston-Salem, NC, and Philadelphia, PA, Clinical ink is advancing the business model responsible for bringing new treatments to market. Visit clinicalink.com.

Media Contact: Jessica Romero | 336.728.6541 | jessica.romero@clinicalink.com

The post Clinical ink and endpoint Announce ‘Industry-First’ Alliance appeared first on Clinical ink.