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WHO WE ARE
The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.
According to the FDA’s website, “Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions.” And a recent survey by the eClinical Forum showed that most respondents believe that RWD and RWE will become much more important in clinical research over the next few years. As a result, many questions have arisen regarding the use cases, data sources, quality of these sources, regulatory guidance documents and so on. The goal of this “Birds of a Feather” session is to present some basic information on these topics and to present a few case examples to illustrate how RWD and RWE are playing an increasingly important role in research.
There has been a dramatic increase in clinical data types, sources and systems in recent years enabling new insights into patient experiences while also presenting challenges in consolidating, standardizing and analyzing these new data streams. The tools for centralizing, integrating, mapping and analyzing data have not kept pace with research and are causing cycle time delays and require numerous manual processes. This technology showcase will describe how new platforms like the elluminate Clinical Data Platform are automating the ingestion of data from numerous eClinical systems and sources, enabling faster data mapping and standardization, supporting risk based data review and advancing both clinical and operational analytics.
Presented by Sheila Rocchio and Sam Parnell of eClinical Solutions.
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Birds-of-a-Feather Webinar: Real-world data (RWD) and real-world evidence (RWE)
Technology Showcase: eClinical Solutions -- Automating the Clinical Data Pipeline for Enhanced Data Review & Analytics
eCF Round-table: Electronic Investigator Site Files (eISF)
This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. We will be discussing challenges Sponsor companies are having evaluating, monitoring and documenting a site’s eISF, and to share best practices, challenges, and ideas.
Facilitators: Ronit Elstein (Pfizer, US) Martijn Griep (Janssen, Belgium)
eCF Technology Showcase: Veeva CDB - Creating a Foundation for Digital Trial Data / Decentralized Trials
Conducting decentralized trials is an important pathway to improving patient centricity, yet they create painful data management challenges that increase costs and delay access to reliable data. As companies move toward digital trials, the number and variety of data sources grows, and visibility into your data declines. Most modern trial designs, including adaptive trials, need interim analyses which require timely access to reliable data. In this technology showcase, Veeva will share their clinical database, Veeva CDB, and demonstrate how it produces a complete and concurrent view of the clinical data. Decentralized trials run better with centralized data management that can speed database locks and support better decision-making during study conduct.
eCF Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services, and by necessity are not technology or vendor neutral. The eClinical Forum does not promote nor endorse any particular technology vendors.