The FDA has long erred on the side of extreme caution when it comes to sharing confidential commercial information and trade secrets out of fear it might violate federal law by disclosing them. Read More
The average daily cost for trials and drug development delays has dropped considerably for sponsors over the years, new data from the Tufts Center for the Study of Drug Development (CSDD) show, owing to a number of factors.
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A recent FDA Warning Letter illustrates to sponsors the importance of properly managing monitoring responsibilities and having a thorough site activation process. In this article, we’ll examine the letter received by the sponsor of a multisite trial of a device for preventing recurrent ischemic stroke and discuss how problems could have been avoided in the first place. Read More
Cohesive, high-performance teams are the backbone of any successful clinical research program. In this Q&A article, Carmin Gade, chief marketing officer for WCG, shares insights on developing strong teams, fostering healthy and open communication, and understanding today’s clinical research workforce. Read More
In an effort to improve access to clinical research in the US and ease enrollment challenges, the Milken Institute has published a new report focusing on distance as a barrier to trial participation, digging deep into demographics and distribution of trials across US counties, as well as offering an interactive map tool filterable by therapeutic area. Read More
The FDA has published overdue draft guidance on developing diversity action plans for clinical trials, moving the agency a step closer to the statutory mandate that all phase 3 trials include such plans. Read More
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. Read More
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. Read More
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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The European Medicines Agency (EMA) is continuing efforts to improve trials in the trade bloc, announcing two new programs that will offer support on clinical trial applications as new transparency rules under its Clinical Trials Information System (CTIS) come into effect. Read More
