White Papers

1. Selecting The Right Pharmacovigilance Vendor 10/3/2023

   Delve into several key benefits of entrusting pharmacovigilance needs to a qualified vendor, from economic efficiency and access to expertise to ensuring regulatory compliance and patient safety, and more.

2. 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.

    
3. Are You Leveraging All Of Your Clinical Data? 9/21/2023

   To develop and execute a successful clinical strategy, trial sponsors must be able to rapidly acquire detailed data insights. Learn how you can better utilize your trial data and achieve greater insights.

4. Developing A Data Strategy For Clinical Trials 9/20/2023

   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.

5. Navigating The Privacy Tightrope For CTIS 9/19/2023

   Examine the challenges, potential risks, recommended best practices, and future trends related to anonymizing personal data for CTIS submissions.

6. From Chaos To Order In 3 Steps: The Guide To Planning Your TMF Migration 9/18/2023

   Utilize this guide when navigating the most important part of any TMF migration: project scoping and planning.

7. Preparing For Post-Market Clinical Follow-Up Under EU MDR 9/15/2023

   Better comprehend the primary challenges faced by the life sciences industry's commercial model in response to the updated EU MDR guidelines.

8. Cell And Gene Therapies Global Clinical Trial Landscape (2018-2022) 9/15/2023

   Dive into how the advancements in technology are heralding a brighter future for patients worldwide, offering new hope and improved healthcare outcomes.

9. Oncolytic Virus Therapies – Global Clinical Trial Landscape - Focus On Asia Pacific 9/11/2023

   Explore the global landscape of oncolytic virus clinical trials, with a particular focus on trends in the Asia Pacific region.

10. 4 Ways FSP Models Are Being Used To Drive Success 9/11/2023

    Dive into several case studies where clients have leveraged clinical research services to surmount critical challenges within the industry and accelerate their achievements.