Featured Articles

1. Professional Services Expedite Hospital's Study Process 11/17/2023

   Explore the details of a transformative partnership where a children's hospital was able to overcome coverage analysis and budget negotiation issues despite a significant staff turnover.

2. Clinical Trial Startup: Insights From The Industry 11/17/2023

   Uncover key survey findings gleaned from the perspectives of over 500 North American clinical researchers regarding technological trends and recommendations for enhancing the overall site experience during trial activities.

3. Global Comprehensive Audit Support 10/26/2023

   Uncover how a pharmaceutical company and its strategic partners were able to provide oversight of key performance indicators relevant to the pharma's business model, which enabled escalation and remediation of any concerns.

4. Good Manufacturing Practices: When Do They Apply? 10/26/2023

   Explore expectations set by the U.S. Food and Drug Administration (FDA) regarding the implementation of current Good Manufacturing Practices standards for investigational drugs.

5. 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.

6. 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.

7. 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.

8. 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.

    
9. 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.

10. Industry-Leading eSource Software Company Receives Part 11/Annex 11 Verification 9/26/2023

    Uncover how an independent confirmation of compliance paved the way for CRIO, Inc., opening up new opportunities and instilling confidence in customers who wish to integrate the eSource system into their own computer software validation strategy.