White Papers
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.