Featured Articles

31. Study Activation Survey Report Sheds Light On Trials 10/18/2023

    Utilize this report to enhance the overall site experience during clinical trial operations, improve site experiences, expedite study initiation, and advance clinical development.

32. Navigating CAPA: Ensuring Compliance And Quality Assurance 10/18/2023

    For clinical development entities, see how a well-executed CAPA system can function as a guide and steer the course toward continual enhancement while upholding regulatory adherence.

33. What Is A Data Monitoring Committee? 10/18/2023

    Look at the specific role DMCs play in overseeing research, and how IRBs rely on the independent DMC’s oversight of interim trial data to ensure an adequate safety monitoring plan is in place.

34. Understanding The RTF Letter 9/26/2023

    The development of new treatments, both drugs and biologics, is a long and arduous process, which can take many years. There are two major obstacles to getting approval and market authorization: the Complete Response Letter and the Refuse-To-File (RTF) letter. Explore the RTF process and how an RTF letter can be avoided.

     
35. CRO Leverages Partnership With Integrated Central IBC To Initiate Sites 9/26/2023

    Discover how a CRO was able to reduce study startup timelines and deliver trial results to the sponsor quicker than expected.

36. Leading eSource Software Company Receives Part 11/Annex 11 Verification 9/26/2023

    Uncover how an independent confirmation of compliance opened up new opportunities and is instilling confidence in customers who are integrating the eSource system into their software validation strategy.

37. Potential Fraud And Misconduct Investigated At Clinical Research Sites 9/26/2023

    Uncover the truth of a for-cause investigation of potential misconduct and/or fraudulent activity on the part of senior management and investigators at one or more sites within a research organization.

38. What Is An sIRB And Why Does My Study Need One? 9/25/2023

    Consider the policies, processes, and benefits outlined by this author when deciding whether to establish a collaborative and compliant working relationship with an sIRB.

39. The Role Of Quality Training In Human Research 9/25/2023

    Explore how an HRPP serves as the organizational backbone, fostering ethical research practices and the highest levels of participant protection.

40. GxP Best Practices For Safer, Smarter, Faster Clinical Research 9/25/2023

    Delve into fundamental GxP principles, essential regulatory aspects, and underscores the critical role GxP plays in ensuring the achievement of prosperous and ethical clinical trials.