Sites appear less informed and prepared than sponsors for the upcoming changes to the ICH E6 — Good Clinical Practices guideline, according to a newly published survey by Avoca, a WCG company.
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A newly launched NIH program puts an ambitious focus on bridging clinical research with primary care practices, especially those in underserved communities, a mission that can help reach underrepresented patients, build trust, make advancements on common health issues and bring more investigators into the fold.
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Ensuring that data and records generated for medical products are secure, trustworthy and of high quality throughout the whole R&D process is a pivotal concern today, with data integrity violations rising and many moving parts threatening to put data at greater risk than ever before. Dan Ayala, chief security and trust officer for Dotmatics, an R&D software developer, talks about the challenges of today’s data landscape in the first of a two-part series.
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Despite usually having professional archivist services on call, sponsors are increasingly tasking sites with complex record retention duties that last for years after trial completion. David Vulcano, honorary president of the Society for Clinical Research Sites (SCRS), discusses how sites feel about long-term record storage, as well as potential risks and compensation considerations for retention agreements.
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The recruitment of participants, especially healthy volunteers, is well-known as a top challenge in clinical research. Patient-to-patient referrals, which are meant to motivate experienced participants to suggest trials to friends, family and personal contacts, can significantly help recruitment efforts, but they can also introduce issues that need to be considered beforehand. The following excerpt from a whitepaper by WCG Regulatory Chair Director R. Bert Wilkins and WCG IRB Chair Erin Brower discusses these challenges.
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