In late September, the European Medicines Agency (EMA) released an important qualification opinion in favor of using eSource direct data capture (DDC) in clinical trials. Although the US Food and Drug Administration (FDA) had expressed support for clinical eSource solutions, the EMA had previously been cautious. The EMA’s opinion identifies many areas where eSource DDC captures source data more efficiently than traditional electronic data capture. It provides answers to a number of regulatory eSource questions and presents recommendations for implementing eSource DDC for use in clinical trials. The opinion also serves to eliminate the prior discrepancy in recommendations between the EMA and FDA.
The EMA response was requested by Novartis Europharm Limited and cites data and insights gleaned 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 Good Clinical Practice-compliant and can be used in support of regulatory filings. The metrics supporting the request indicated that the time to study data availability dropped six-fold due to its use of eSource DDC. Furthermore, the number of data points that remained unchanged throughout the studies increased by 7 percent, which indicates fewer changes due to data queries or monitoring. What’s more, the time to resolve data queries dropped by more than half.
Other documentation cited in the qualification opinion signalled that the use of eSource technology in clinical trials had the potential to improve data quality and foster better operational efficiencies. The regulatory opinion indicated that eSource data can be submitted to support a marketing authorization application and noted that using eSource to collect data may help identify or reduce missing or erroneous entries.
Despite growing evidence to support the use of eSource solutions for clinical trials, industry acceptance has been slow — mostly due to outdated process models. The EMA’s opinion should help to increase the adoption of these electronic data capture technologies industry-wide. Now, with both the FDA and the EMA showing support for eSource, it’s time for drug sponsors and CROs to begin to change the existing industry paradigm in order to implement these advancements and improve the way clinical research is conducted.
Join this free webinar to learn about the implications behind the EMA’s qualification opinion and the benefits of using eSource solutions in clinical trial conduct.
Ed Seguine, CEO, Clinical Ink
Ed Seguine brings more than 20 years of experience as a clinical technology executive at big pharma and start-up organizations to the Clinical Ink team. Mr. Seguine joined Clinical Ink in late 2009 with the goal of creating a company that would eliminate problems caused by current paper-based processes and technologies.
Prior to joining Clinical Ink, he served as general manager, trial planning at Medidata Solutions, where he managed acquisition integration activities and product positioning prior to the company’s IPO. He also served as CEO of Fast Track Systems, where he oversaw the turnaround process and established early commercial successes for a novel product that became the rationale for acquisition by Medidata Solutions. Prior to Fast Track, Mr. Seguine was a founding manager of the Eli Lilly & Co. venture capital funds, e.Lilly and Lilly Bioventures, focusing on technology and biotech and device companies. Mr. Seguine has also been intimately involved with key industry initiatives, including Clinical Data Interchange Standards Consortium (CDISC) and eClinical Forum. He is a frequent presenter at industry events and publishes regularly. Mr. Seguine earned a Master of Business Administration from Indiana University-Bloomington and a Bachelor’s degree in Finance from Brigham Young University.
Jonathan Andrus, Chief Business Officer, Clinical Ink
Jonathan Andrus has more than two decades of experience developing eClinical solutions that integrate data and technology to help life science companies optimize study execution. As chief business officer at Clinical Ink, he is focused on helping study sponsors and clinical research organizations (CROs) better leverage eSource, eCOA and ePRO data for use throughout their trials. Johnathan has spent his career in leadership positions at eClinical service and technology organizations, supporting industry associations like SCDM, CDISC, DIA and ASQ. Thanks to his vast industry experience, he is also an active thought leader, blogger and presenter. At Clinical Ink, Johnathan also works on building relationships and forging strategic partnerships with sponsors, CROs, regulatory bodies and clinical research professionals across the industry.
Who Should Attend?
This webinar will be suitable for executives, scientists, directors and managers from pharma, biotech and CROs working in drug development, including:
- Strategic drug development
- Head of therapeutic areas
- Clinical operations
- Clinical science
- Outcomes research
- Data management
- Outsourcing and procurement
- Clinical trial planning and optimization
What You Will Learn
This webinar will discuss:
- The implications behind the EMA’s qualification opinion
- eSource’s cost and time savings and the data accuracy improvements cited in the opinion
- Clinical Ink’s role in the Novartis trials identified in the opinion
- The best steps forward for the industry in light of the EMA’s announcement
Clinical Ink, a global clinical technology company, offers data certainty from source to submission. Our eSource clinical technology and configurable ePRO and eCOA modules — a suite of solutions for capturing and integrating electronic data from sites, clinicians, and patients at its source — naturally enhance your clinical trial workflow by reducing manual labor, providing anytime, anywhere data access, and saving resources as your trials progress. Accelerate the completion of key clinical development milestones in your study and confidently manage your trial’s critical decisions with our flexible menu of collaborative services, remote monitoring support, and a complete, real-time view of your trial. Visit clinicalink.com.