ECLINICAL INSIGHTS
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ICH E6(R3) And Defining What Is Critical To TMF Quality
By applying Quality by Design to clinical trials, sponsor companies can rise to meet the elevated role and importance of the TMF in the face of ICH E6 (RF3).
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3 Tips For Selecting Your eTMF Platform
Each eTMF platform presents its own set of advantages and drawbacks. Be sure to incorporate these three tips when considering a new eTMF vendor and its services.
CTMS RESOURCES
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Explore how direct communication and integration between key operating systems contributes to a more efficient and compliant trial.
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Uncover how advancements in clinical trial management systems signify a significant shift towards more streamlined and effective clinical trial management, ultimately enhancing the quality and pace of medical research endeavors.
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A must for all clinical leaders, this webinar shares strategic, operational, regulatory, and financial benefits of a seamless CTMS and eTMF integration. Watch the webinar to find out why CTMS-eTMF integration has increasingly become imperative for sponsors and CROs around the world.
EDC RESOURCES
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Explore how the solutions and approaches offered by CDS can help different research stakeholders conduct more cost-efficient clinical trials in the industry's pharmaceutical, biotech, and device sectors.
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Consider DIA GCP & QA Community Chair Terry Katz’s perspective on repurposing and analyzing EHR data for clinical research.
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Gain insight from an eSource study observing digitally received data as far back as 2007 to just before initial guidance was released by the U.S. FDA in 2013.
ETMF RESOURCES
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Learn more about LifeSphere CTMS, eTMF, and EDC – highlighted in this video from ArisGlobal’s annual customer event, BREAKTHROUGH.
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Discover how a configurable and customizable eTMF can lend itself to better information control during a clinical trial while boosting security and regulatory compliance efforts.
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An eTMF system can help Clinical Operations professionals manage the deluge of documents and data, but what capabilities are right for your situation? What is the best way to make the move to a modern eTMF from paper, spreadsheet trackers, or legacy tech to a new eTMF? Hear answers to these questions and more from a fellow Clinical Operations leader with experience in making the transition to an eTMF built for today's research ecosystems.