White Papers
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Adopt Tech Solutions To Innovate And Streamline Regulatory Services
10/30/2023
See how transformative technologies like AI and ML augment the regulatory professional workload to ensure compliance, patient accessibility, and rapid timelines for approval for global drug campaigns.
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A Model For Improving TMF Management
10/30/2023
Get pragmatic details of what it took to build a successful partnership, why it has become a model for other departments within Regeneron, and lessons learned you can apply in your organization.
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ePROs: How They’re Transforming Oncology Research
10/30/2023
ePRO and eCOA are helping to overcome oncology-specific challenges in clinical research. Find out how you can make life easier for patients when it matters most.
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Cell And Gene Therapy Logistics
10/27/2023
Take an in-depth look at the obstacles encountered during the Cell and Gene Therapy (CAGT) Logistics asset journey and how to overcome them.
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Navigating The Complex Oncology Landscape: Rethinking Trial Strategy
10/27/2023
In the clinical trial space, it's important to stay informed about global oncology trends impacting sponsors. Utilize these valuable insights to strategically enhance your clinical study approach.
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The Essential Role Of Adjudication Technology In Clinical Trials
10/19/2023
With adjudication, learn how teams can enhance the quality and integrity of their research, paving the way for impactful and reliable outcomes in clinical research.
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Clinical Trial Disclosure Compliance: A Moving Target
10/19/2023
To date this year, 115 updates to clinical trial disclosure rules have been tracked across global regulatory agencies. See what types of changes have occurred, where they were, and how they are implemented.
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The Unique Value Of Integrated Safety Services And Technology
10/13/2023
In your search for an integrated safety partner, begin by assessing a vendor’s previous experience and whether their PV knowledge aligns with the needs of your product portfolio.
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Creating A Sustainable Business Model For Cell And Gene Therapies
10/5/2023
Avoid product launch delays and expand patient access to CGTs by understanding and meeting regulatory guidelines and securing approval for reimbursement of treatment costs.
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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.