White Papers

1. Renewed Interest In Clinical Research Helps Change The Conversation About Trial Participation 6/27/2022

   This white paper focuses on recent consumer openness towards clinical research and how it represents an exciting opportunity for the biopharma industry to engage with patient communities and accelerate research.

2. A Guide On Successfully Managing An AME Clinical Trial 6/23/2022

   Finding a partner to perform your AME studies in a reasonable time frame, let alone one with an excellent track record, may be a challenge. Discover how these challenges can be overcome in the available white paper.

3. Unlocking New Insights By Connecting Patient-Level Clinical Trial Data To Real World Data 6/20/2022

   Discover data linkage: a cutting-edge innovation that unlocks a new frontier of enhanced evidence generation by linking clinical trial data and real world data at the patient level.

4. Steps To Successfully Complete An FDA Inspection 6/20/2022

   We outline the steps to take before, during and after an FDA inspection so the FDA’s call to schedule an inspection doesn’t have to be a nightmare scenario.

5. A Guide To Pharmaceutical Quality Management 6/16/2022

   Despite the inherent challenges of connecting quality and compliance data, there are tools that can help you to ensure quality's connectedness and central bearing. 

6. Mitigating Supply Chain Risks From Unpredictable Demand 6/14/2022

   Patient enrollment can vary widely within regions, countries and sites due to competitive enrollment and other variables. This unpredictability introduces risk into the supply chain. Learn why it is critical to be aware of these risks and understand how best to mitigate them within trials.

7. Hassle-Free Imaging In Clinical Trials 6/14/2022

   In this white paper, consider how far the field of imaging has recently come, and read about the latest innovations, and what lies ahead.

8. Why More Drugs Than Ever Are Approved Through 505(b)(2) 6/6/2022

   Discover how bringing a modified version of an existing drug to market through 505(b)(2) can offer a clear path to approval, a differentiated product, and at least some period of marketing exclusivity.

9. What Every Clinical Team Should Consider Before Developing The Next Protocol: Putting Volunteers First 6/3/2022

   Even though everyone applauds the renewed focus on patients as a positive development, some say it is time for biopharma companies to turn their attention to another audience: clinical trial participants.

10. Comparator Local Sourcing Strategies: Leveraging Advantages And Avoiding Common Pitfalls For Clinical Trials 6/3/2022

    The growing demand for comparators is causing many supply chain managers to explore available sourcing options. Explore alternative local sourcing strategies, including advantages and disadvantages.