Newsletter | March 7, 2024

03.07.24 -- Strategies For Seeking Multiregional Regulatory Approval

REGULATORY & COMPLIANCE

Strategies For Seeking Multiregional Regulatory Approval

Guest Column | By Peter Embley, BSc. (Hons), Dip. Reg. Aff, FTOPRA INSEAD

Consultant Peter Embley discusses the importance of developing a regulatory strategy (RS) that intends to support both U.S. and EU regulatory approval.

Accelerated Clinical Trial Disclosure Starts Here

Brochure | Citeline

See why TrialScope Disclose is trusted by 16 of the top 20 industry clinical trial sponsors for optimizing, streamlining, and simplifying the clinical trial disclosure process from registration to results.

Similarities And Differences Between The CTA And IND

Infographic | Veristat, Inc.

Use this infographic when considering the purpose, content, and procedural similarities and differences between the clinical trial authorization and investigational new drug application.

Limiting Prescription Drug Misuse: Assessing Human Abuse Potential

Article | Altasciences

Learn how the FDA has undertaken efforts to manage the misuse and abuse of prescription drugs, including opioid analgesics, through guidelines for understanding the abuse potential of new drugs.

OUTSOURCING MODELS

Channel Your Inner Child To Become A Better Clinical Research Professional

Guest Column | By John R. Nocero, Ph.D., and Andrea L. Bordonaro, MAT

Sites, CROs, and sponsors sometimes have contentious relationships. It doesn't have to be that way. Discover how to leverage ‘The Zones of Regulation’ to better manage emotions and become a better partner and CRP.

Don’t Sign Yet: How To Detect And Avoid Hidden CRO Contract Costs

Article | inSeption Group

Navigating the complex landscape of clinical trials can be challenging. Utilize this reliable CRO checklist to empower teams to stay ahead and safeguard every trial's budget effectively.

The Unique Value Of Integrated Safety Services And Technology

White Paper | By Archana Hegde, Richard D’Mello, and Scott Fonseca, IQVIA Safety & Regulatory Compliance

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.

5 Ways CROs Can Drive A More Competitive Client Experience

Article | Sikich

Providing excellent client experiences is a hallmark that separates the most innovative and value-focused CROs. Find out the ways CROs are modernizing and simplifying technologies that help clients.

Improve eCOA Data Collection And Clinical Trial Efficiency

Brochure | Kayentis

Ameliorate your eCOA data collection and clinical trial efficiency with Kayentis and ClinOne's combined solution, covering eCOA, virtual visits, consent management, patient engagement, and more.

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