FEATURED ARTICLES

• Developing A Data Strategy For Clinical Trials

  This white paper outlines a standardized method for developing a data strategy that can be tailored to a company's current needs and adapted as those needs evolve.

• Understanding Various Site Use Cases For eSource And EDC

  Learn how leveraging comprehensive electronic data capture solutions can be pivotal in ensuring the successful execution of clinical research trials.

• Public Perceptions Of Clinical Trials: A Comprehensive Survey

  To gain insight into the public's general perceptions and understanding of clinical research, review the findings from this survey, which encompassed 1,000 randomly selected U.S. residents.

• Rare Diseases: Expected Boom In Development And Approval

  Delve into the details of the FDA's "Operation Warp Speed for Rare Diseases" initiative and what sites should do to prepare.

• The Advantages Of Outsourcing IRB And IBC Reviews To One Partner

  To streamline reviews, learn how sponsors can coordinate both IBC and IRB assessments through a vendor offering integrated resources.

• Mobile Application Considerations For Clinical Trials And Beyond

  Delve into fundamental definitions, navigate through the regulatory landscape, and examine common applications of mobile apps in research.

• What Sponsors Need To Know About Medicare Coverage Analysis

  Discover ways to bridge the gap between sites and sponsors regarding the Medicare Coverage Analysis (MCA) for industry-sponsored trials to better align expectations on both sides and avoid frustration.

• Partner Helps Biotech Organization Become Inspection Ready

  Delve into the details of how after receiving proper consulting, this renowned biotech company was able to conduct thorough site inspection readiness activities and receive an accelerated FDA approval.

• 4 Unique Challenges Of Oncology Trials

  Consider these strategies for overcoming the unique characteristics of oncology research and the challenges researchers must confront to enhance the likelihood of successful drug development.

• IBC Vs. IRB: What’s The Difference?

  Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring additional oversight by an institutional biosafety committee (IBC). So what’s the difference between an IBC and an IRB? 

• Ace Your Next FDA Inspection

  This author provides key insights and guidance to sponsors and sites for mitigating risks and ensuring compliance for a successful U.S. Food and Drug Administration inspection.

• New & Emerging CMS Policies: Medicaid’s New Clinical Trial Policy

  Explore the key considerations institutions should take into account to best navigate impending CMS changes and what to anticipate for the future of clinical trial enrollment for Medicaid beneficiaries.

• Reporting Unexpected Incidents To The IBC

  Utilize this comprehensive guide to better understand reportable incidents and the appropriate channels for communication when unforeseen events arise.

• Perceptions Of Clinical Trials

  Dive into the poll results from 1,000 random U.S. residents for an overview of their general perception and understanding of clinical research.