Winston-Salem, NC – Clinical ink, a global life science technology company, is expanding its patient engagement solutions with the inclusion into its 21 CFR Part 11 platform of the SPUR^TM behavioral assessment tool and the proprietary d.tells smart AI engine. These digital tools were developed by Observia, validated by extensive published literature, and used in over 40,000 patients across 27 therapeutic areas by multiple large pharmaceutical companies.

Protocol compliance and retention are critical factors for the success of clinical trials. Behavior can be predicted and modified by the SPUR digital assessment tool which identifies behavioral drivers unique to each patient. This provides supportive information to the patient, as well as measures of non-adherence risk to investigators.  In addition, SPUR provides investigators with personalized guidance for each patient, including the communication style and content that will resonate with a specific behavioral phenotype. The benefits encompass optimized engagement and reduced risk of non-adherence, such as reduced drop out from a clinical trial. SPUR can be administered either prior to or after consent and then readministered during the trial. 

SPUR can be further enhanced with the d.tells AI engine.  d.tells chooses and distributes the most appropriate content and features from the solution library for each patient’s behavioral profile. It further refines the personalization by adapting the frequency, duration, and tone of the messages and notifications it sends, according to the patient’s sociomedical and behavioral data.

Nicholas Alp, MD PhD, Chief Medical Officer of Clinical ink commented “I am excited to see the value that SPUR will bring to improving adherence, retention, and data integrity in clinical trials. Not only does this validated tool help sponsors comply with FDA guidance on lifestyle standardization in certain therapeutic classes such as GLP-1, but it also offers unique insights to investigators, helping them support participant adherence to the protocol. This predicts and reduces the risk of drop out, preserving study power.  I wish SPUR had been available during my career as a clinical trialist.”

“I’m thrilled that Clinical ink has decided to incorporate SPUR into their offering” says Kevin Dolgin, Head of R&D at Observia. “Clinical ink is one of the most forward-thinking clinical trial service providers and their commitment to bring behavioral science into the world of clinical science is proof of this. I strongly believe that thanks to Clinical ink’s initiative, trials will now be more efficient, more precise, and far more patient centric.  At Observia, we look forward to continuing to support Clinical ink with behavioral science input while we assist our commercial customers post-launch.  I can think of no organization that is better suited than Clinical ink to serve as the bridge between clinical and behavioral science.”

The terms of the transaction were not disclosed.

About Clinical ink

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

About Observia

Observia is a Paris-based health tech company founded in 2011 and a pioneer in personalized digital solutions, dedicated to the engagement and support of patients suffering from one or more chronic diseases. The company is the inventor of SPUR^TM, a validated, ground-breaking tool for predicting health behavior. Observia’s expert teams are committed to improving health outcomes through behavior change, for everyone, everywhere. The solutions developed by Observia are deeply rooted in proven behavioral science and new technologies. 

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Winston Salem, NC – Clinical ink, a global life science technology company, announces the promotion of John Pappadakis from EVP, Global Business Development to Chief Commercial Officer and Megan Petrylak from EVP, Clinical Operations to Chief Operating Officer. Jonathan Goldman MD, CEO of Clinical ink commented: “I am delighted to announce the promotion of two of our most seasoned and experienced executives.  With John Pappadakis as CCO, and Megan Petrylak as COO, Clinical ink has the ideal leadership team to drive us to the next phase of growth.  Our unwavering focus on quality and innovation make us the partner of choice for our biopharmaceutical partners and the patients they serve.”

John Pappadakis, Chief Commercial Officer

John has 34 years of experience in sales and marketing leadership roles within the pharma industry. His career includes commercial and R&D positions at Oracle and IMS Health, following positions of increasing seniority at Pfizer and Parke-Davis where he launched over 30 new molecular entities.

As Clinical ink’s EVP, Global Business Development, John devised an innovative go-to-market strategy centered around the addition of scientific and medical expertise, and the incorporation of new FDA requirements into the Clinical ink technology platform.  His vision inspired the creation of the company’s newest integrated cardiometabolic product, GlucoseReady.  Under his leadership, the company recruited a world-class commercial team and demonstrated record levels of key BD metrics.

As Chief Commercial Officer, John will further diversify Clinical ink’s customer base with the addition of new large, medium and small biopharmaceutical companies, whilst solidifying the company’s CRO relationships and other industry alliances.  His plans include the deepening of the therapeutic area focus on cardiometabolic, CNS, immunology and oncology, the introduction of an end-to-end decentralized/digital health platform centered around eCOA and EDCXtra, as well as new licensing-based business models.  Moving forward, John will be announcing novel and transformative AI-driven clinical trial innovations.

Megan Petrylak, Chief Operating Officer

Megan Petrylak has over 14 years of clinical trial experience in senior operational leadership roles. She has particularly focused on driving successful outcomes in phase 1-3 clinical trials for a wide range of global biopharmaceutical and CRO customers. Prior to her 6 year tenure at Clinical ink, Megan served as Director of Project Delivery at Worldwide Clinical Trials. Prior to that role, she headed Bioclinica’s centers for imaging and eClinical project management.

As EVP, Clinical Operations, Megan oversaw Clinical ink’s entire customer, site, and patient-facing operations function.  She augmented the team with deep expertise in data management and data quality, mandating a quality-first culture. This resulted in impressive increases in customer satisfaction, complemented by significant reductions in all study build and execution metrics and excellent quality outcomes.  In addition, Megan’s team successfully launched new products including GlucoseReady and EDCXtra and has developed a range of industry partnerships including TransPerfect for translations and eClinical Solutions for complex data solutions.  Her deep subject matter expertise in eCOA and data management has been recognized at numerous industry consortia and she has served as an expert speaker at meetings such as the Society of Clinical Data Management.

In her new role as Chief Operating Officer, Megan will oversee significant growth in Clinical ink’s revenue, broadening the customer base and expanding the range of integrated solutions. Her plans include upscaling the team to support the planned growth in revenue and margin profile, aided by automation of key operational and data processes. Megan will continue to prioritize quality to drive operational excellence and ensure exceptional delivery to clients.  

About Clinical ink

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

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We have reviewed the final 2024 FDA guidance on Conducting Clinical Trials with Decentralized Elements (DCTs). While the general concepts are not new, the guidance clarifies many key points that impact the clinical trial experiences for sponsors, investigators, clinical trial industry supporters, and participants. The guidance provides recommendations and best practices for integrating decentralized elements in clinical trials, while ensuring regulatory compliance, maintaining data quality, and supporting participant safety.

The final 2024 guidance updates the Agency’s prior guidances on decentralized clinical trials and digital health technologies (DHTs), clarifying considerations for designing DCTs based on appropriateness of telehealth or in-person visits for trial participants, investigational products, medical conditions of the trial population, and use of DHTs. The current guidance maintains the focus on two overarching principles, participant safety and data integrity by incorporating responsibilities specifically related to DCTs for sponsors, investigators and participants.

The use of decentralized components, such as telehealth or home visits in a clinical trial reinforces prior FDA guidance on patient-focused drug development (PFDD), by allowing trial activities to occur in places where it is convenient for participants. This benefits both participants and trials by reducing participant burden, improving accessibility, and improving retention.

The guidance references participants use of their own digital health technology, often referred to as ‘Bring Your Own Device’ (BYOD), with the caveat that sponsors make provisioned devices available to participants who do not have their own, to ensure that participation is accessible for all potential participants. At times in the past, sponsors have questioned whether the FDA would accept data collected via BYOD when considering regulatory approval. By describing use of a participant’s own DHT in the final guidance, it is clear that the FDA considers data collected via BYOD acceptable (see also the 2023 FDA guidance on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations).

While recognizing that DCTs may risk increased data variability compared to traditional site-based trials, the guidance highlights the need for a strong risk-based monitoring plan to maintain data quality. In a DCT, data integrity can be supported through robust remote trial monitoring plans to ensure compliance with study protocol conventions and best practices for data collection. This may include use of video to supervise remote visits and real-time access to study data and standardized reports/dashboards. While audio/video telehealth interactions do not need to be 21 CFR Part 11 compliant, all study data captured during the virtual visit must conform to these guidelines (Section J). In addition, site and de-identified participant access details (date/time, etc.) should be captured in a robust audit trail (Section J). Critically, participant data privacy and security must be ensured during remote visits/events in decentralized settings.

The guidance also states that training participants on study guidelines is an important element for successful DCT and may be provided by site staff or within the application (Sections A, B, C, D, and J). Furthermore, to improve data consistency and limit variability, protocols for DCTs should include specific instructions for where and how trial activities are to be performed.

Participants must adhere to recommended safety procedures when health/safety issues occur to document potential Adverse Events (AEs) when they are not at the study site. However, the guidance advises that it is helpful to collect real-time information from participants when event-triggering thresholds are exceeded. Safety monitoring plans should ensure that AEs, including those that are identified remotely, are documented, assessed, and addressed. The safety monitoring plan should also detail the type of information specifically collected using DHTs, how it will be monitored, what actions participants should take if something concerning occurs and how trial personnel should respond to electronic alerts (Sections B and I).

The implications for sponsors and vendors have expanded beyond the delivery of enabling technology to include a serious focus on staff training, all quality assurance processes and foundational quality management systems. These are areas where we have focused our attention to ensure compliance not just for audit but for successful trial execution.

Authored on behalf of Clinical ink by Yamamoto, R, Anderson, D, Bowen, C, & Barrasso, B

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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.

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Winston-Salem, NC – Clinical ink, a global life science technology company, announced the appointment of Dr. Nicholas Alp as Chief Medical Officer and EVP, Medical Science. In this role, Dr. Alp will lead the creation of innovative solutions and commercial strategies for clinical trial technology based on his experience as an interventional cardiologist and clinical trialist. His responsibilities will include the oversight of Clinical ink’s scientific advisory board, providing medical input to customer projects, and clinical focus to our range of products solutions.

Dr. Alp stated: “I am excited to join the leadership team at Clinical ink, where I look forward to helping my colleagues develop and deploy world-class data science solutions to enhance scientific insights and accelerate drug development for our Biopharma partners and for the benefit of patients”.

Dr. Alp has more than 30 years of clinical research experience and has spent the last 13 years in the life science industry. Prior to Clinical ink, he served as Senior Vice President of the Medical Department and head of Cardiometabolic Research at Medpace, a global clinical research organization.

Previously, Dr. Alp was Vice President and Global Head of Cardiovascular Drug Development at ICON. He simultaneously held appointments as a Consultant Interventional Cardiologist at the John Radcliffe Hospital, Oxford and a senior academic role in Cardiovascular Medicine at Oxford University.

Dr. Alp trained in medicine at London University and Oxford University, completed a PhD in Immunology at Cambridge University, with a further post-doctoral DM degree in Vascular Biology at Oxford University. He has also contributed to more than 70 peer-reviewed publications and books.

”I am delighted to welcome Nicholas to Clinical ink. He is a visionary clinician scientist with deep clinical research experience in cardiometabolic disease and other key therapeutic areas. Our customers and the patients they serve will benefit greatly from his ability to deploy clinically relevant eCOA, DDC, connected devices and patient engagement solutions” commented Clinical ink Chief Executive Officer Jonathan Goldman, MD.

About Clinical ink

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

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In an effort to foster better adoption of eConsent, the European Forum for Good Clinical Practice (EFGCP) has led an eConsent initiative with the intent to harmonize eConsent terminologies, create value models of eConsent for stakeholders, and offer guidance on eConsent processes.

Clinical ink’s Senior Product Manager Liz Goodman co-leads the EFGCP eConsent library workstream with other industry experts. This workstream just released the harmonized eConsent glossary and published an article in Applied Clinical Trials on the their efforts over the past year.

We are pleased to collaborate with key industry leaders on this critical initiative, and look forward to bringing eConsent to the forefront of clinical research software. Reach out today to learn more from our industry experts on how eConsent can work for your research trial!

Read the article and access the EFGCP eConsent glossary.

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This article describes how behavioral science can be applied in cardiometabolic clinical research to augment drug interventions. This combined approach addresses the Health Inequity gap while also increasing patient engagement.

Clinical Scenario Case Vignette

Years ago, one of us was a young doctor in conversation with a patient regarding enrollment in a Type 2 Diabetes research study. The conversation related to the patient’s high use of basal insulin (>150U/day) and dietary habits around healthy eating. The patient explained that he lived alone and his daughter had repeatedly tried to make him eat healthier by introducing vegetables as a dominant part of his diet, but he couldn’t tolerate the change. He became uncomfortable, dizzy, sweating, fatigued, and hungry – all classical symptoms of hypoglycemia. He stopped the healthy diet and resumed his normal diet. When asked how he had managed to reduce his insulin dose with the healthy diet to anticipate the lower amounts of carbohydrates, he looked baffled.

His understanding of diabetes left him unable to make appropriate health choices and his daughter lived far away and only saw him on occasion. He ate TV dinners and found preparing food for himself an insurmountable challenge. His poor adherence was due to low “Health Capital” or “Health Literacy”, and his resource network wasn’t able to compensate.

Incorporating Patient Behavior into Clinical Guidelines

In clinical treatment guidelines, this is phrased as “Social Determinants of Health” which is presumed to account for 50% of health outcomes. SDoH are equally deemed by the American Heart Association to constitute a major impediment for delivering upon their ambitions of “Goals: to improve cardiovascular health of all Americans by 20% while reducing deaths from CVD and stroke by 20%.”

In clinical trials, we excel in quantifying the biometrics that constitute predictors of poor health outcomes. Zooming in on the cardiometabolic space, we are becoming increasingly diligent in describing the causalities of dysglycemia, dyslipidemia, other markers of atherosclerosis, aspects of hypertension, fatty liver parameters etc. toward adverse Health Outcomes. These are important additions to our scientific understanding of the diseases that together characterize the “Cardiometabolic Pandemic” we see unraveling across the globe with more than 650 million people being obese and 530 million people (10.5% of the world’s population) living with Type 2 diabetes.

In the “non-health related” part of our lives, social media, mainstream media, streaming services, and other outlets have used complex algorithms for years. These approaches have been used to understand consumer preference, direct advertising, and influences on lifestyle behavior, with very high levels of acceptance. For the pharmaceutical industry and investigators, the question now beckons: are there validated methods for how similar approaches can be applied in clinical research to quantify and modify behavioral and psychological factors to augment treatment efficacy and weight loss? And subsequently, is it possible to include a behavioral modification tool to our clinical trial platforms to ensure lifestyle standardization throughout the study? Once the data is available on an individual trial basis it may be possible to obtain a marketing license for a standalone or companion digital therapeutic.

We Suggest the Following General Approaches to Clinical Trial Design:

First, in the context of a clinical trial for diabetes or obesity we need to adhere to FDA recommendations to standardize lifestyle modification – Guidance for Industry Developing Products for Weight Management (fda.gov). But we can take this further by really trying to understand the individual patient and ensuring they get the best possible outcome from the drug and treatment advice.

Second, we can quantify the patient’s personality, mood, and health behavior by screening at baseline. This is important as personality is a known determinant of nonspecific outcomes such as adherence in clinical trials.

Third, we propose using validated behavioral digital tools that are based on principles of cognitive behavioral therapy. This will create a dataset that can characterize and describe these in contexts with the biometrics.

Fourth, we recommend a feedback loop to the patient. We advocate the use of validated behavioral modification modules combined with machine learning. This can provide real-time feedback to clinical trial participants, with the goal of modifying their current behaviors in real time.

Translating General Recommendations to Specific Actions

All of this needs to happen with patient centricity in mind and without increasing the patient burden of a clinical trial. This can only happen if the insights are captured in a seamless site and patient experience solution.

At the patient level this approach will improve the likelihood of therapeutic effectiveness and ensure that activity levels, food intake, and glucose levels are aligned with a putative lifestyle standard for weight loss. Let’s apply digital health technologies in addressing the health inequities of cardio metabolic diseases. After all, it’s not the efficacy obtained in a clinical trial that delivers the promise of a drug, it’s the effectiveness of it observed in the real world. We believe that technology holds the promise of mitigating this gap if we are sufficiently curious to understand how to do it.

The question is how to take a structured approach to capture and characterize behavior and potentially provide “cognitive behavioral therapy” to modify behavior.

Our Specific Solutions to Capture and Assess Behavior are as Follows:

Clinical ink excels in capturing data directly from patients in clinical trials in a patient-centric manner. We now have an important opportunity to gain insights beyond capture of endpoints into behavioral aspects impacting clinical trial protocols. If patients are unable to adhere to the drug treatments or follow trial protocol procedures, neither they nor the sponsors will have the insights needed to thoroughly evaluate new treatment options for “people like them”, and the patients in the trial will have to be replaced, adding cost and time.

We have thus partnered with Observia, the developer of SPUR, and together we are for the first time bringing a clinically validated digital behavioral assessment into clinical trials for drug development programs.

SPUR stands for “Social, Psychological, Usage, and Rational”, the four overarching dimensions categorizing the drivers of patients’ decision-making processes. SPUR is a dynamic and predictive assessment tool that integrates decades of proven behavioral science into a validated digital solution for detecting a patient’s risk of non-adherence and the drivers of their health behavior.

In our integrated solution, investigators are provided with insights into risk of non-adherence as well as specific underlying drivers of the risk. For example, two people could both present the same high risk of non-adherence, but for one, that might be because they have limited understanding of the benefits of the proposed treatment coupled with a difficult family situation whereas the other person’s risk is primarily driven by more practical difficulties.

Conclusion

Every individual has a unique personality. The best way to ensure their successful participation in a clinical trial is to formally assess their behavior and risk of adherence, and ensure they have the right support.

Having these insights available in real time will provide clinical trial investigators with objective and validated points to consider in the enrollment of patients, and adequately manage the risk of dropout and adherence to drug and protocol.

Authors

Jonathan Goldman, M.D.
CEO
Clinical ink

Christian Born Djurhuus, M.D., PhD, BSc.
Diabetes Advisor to Clinical ink
Owner of Djurhuus Consulting

WATCH ON DEMAND

 

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Winston-Salem, NC – Clinical ink,  a global life science technology company, is expanding its patient engagement suite with the inclusion of the SPUR^TM behavioral diagnostic tool created by Observia. This unique integrated solution combines assessment of patient behavior with lifestyle modification, eCOA, eSource, and Digital Biomarkers.  It is available for both clinical development and marketed pharmaceutical products.

SPUR^TM is a behavioral diagnostic tool that is used to determine adherence to protocol and drug, provide guidance for lifestyle changes, and modify behavior by personalized intervention. The tool has been validated in numerous patient populations including diabetes, hypertension, respiratory disease and others. It collects a comprehensive dataset of behavioral drivers (social, psychological, usage, and rational), that help quantify the motivation for each patients’ decision-making and allows for personalized support at the patient level.

The collaboration with Observia allows Clinical ink to capture a holistic view of patient behavior together with clinical outcomes and digital biomarkers.  Behavior and cognition represent a previously neglected dataset, permitting improved adherence to trial protocols and standardization of lifestyle advice in complex chronic indications.

Jonathan Goldman, MD, CEO of Clinical ink, commented: “I am delighted to announce this collaboration with Observia to create a best-in-class platform.  Understanding patient behavior is an essential but often overlooked component of clinical trials.  We hope this addition to our integrated technology solution will improve patient engagement with measurable benefits for patient adherence and trial outcomes.”

“As the world of clinical trials transforms to become more digital, we are thrilled to bring our SPUR^TM profiling tool into the Clinical ink service offering. We strongly share Clinical ink’s vision that improving patient experience equals improving clinical trial performance,” says Kevin Dolgin, Head of R&D at Observia. 

To learn more about this partnership or our solutions, contact us here.

About Clinical ink

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

About Observia

Observia is a Paris-based health tech company founded in 2011 and a pioneer in personalized digital solutions, dedicated to the engagement and support of patients suffering from one or more chronic diseases. The company is the inventor of SPUR^TM, a validated, ground-breaking tool for predicting health behavior. Observia’s expert teams are committed to improving health outcomes through behavior change, for everyone, everywhere. The solutions developed by Observia are deeply rooted in proven behavioral science and new technologies. 

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Winston Salem, NC – Clinical ink, a global life science technology company, is setting a new industry benchmark in advancing study build timelines. Harnessing the power of the latest eCOA technology, Clinical ink can now reduce study build timelines to as little as 10 days.

Clinical ink’s scalable software solution offers enhanced precision right from the start to ensure trial success. Key features of Clinical ink cutting-edge eCOA technology include:

• What You See Is What You Get (WYSIWYG) Design
  Streamline the instrument build process with a codeless GUI-driven design interface providing immediate and intuitive visibility into what sites and subjects will see.
   
• Flexibility by Design
  Gain unprecedented flexibility with build tools that support collaborative work, enabling teams to concurrently work and alter a study’s design as needed.
   
• Direct Translation System Integration
  Eliminate the need for manual file distribution and text copy through cumbersome channels, promoting efficiency.
   
• Custom Library
  Dedicated repository of approved and validated content tailored to your specific needs.

“Setting a 10-day benchmark in study build timelines is proof of the strength of the latest Clinical ink eCOA technology,” comments Megan Petrylak, EVP, Clinical Operations. “Clinical ink is redefining speed and raising the bar for efficiency and accuracy, ensuring that clinical study development is agile and meticulous.“

Through a seamless, codeless user interface with direct integrations, Clinical ink eCOA advancements ensure a streamlined and precise study build process. These are the latest advancements delivered by Clinical ink, following its recently unveiled Data Management services, to further enhance its comprehensive range of eCOA, direct data capture, patient engagement, and digital biomarker solutions.

About Clinical ink

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

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Our recent blog, published in DIA Global Forum, discusses how technology and human involvement can work together to conduct clinical trials in a compliant and safe manner. In this article, Bill Barrasso, Clinical ink Chief Compliance Officer, refers to the recent guidance from the FDA and EMA on using digital health technologies, software, and electronic data in clinical research. Bill also provides some recommendations and best practices for sites and sponsors to ensure effective planning and communication, as well as patient well-being and safety.

Read Human Interaction: Risk-Mitigation Recommendations When Using Technology in Clinical Trials and learn more about how effective planning and human engagement complement technology use in trials.

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