Newsletter | May 2, 2024

05.02.24 -- ICH E6(R3): Defining What's Critical To TMF Quality

REGULATORY & COMPLIANCE

ICH E6(R3): What's Critical To TMF Quality

Guest Column | By Ken Keefer, MBA, PMP, Keefer Consulting Inc.

By applying Quality by Design to clinical trials, sponsor companies can rise to meet the elevated role and importance of the TMF in the face of ICH E6 (RF3).

Key Changes For Computerized Systems And Electronic Data

Article | Florence Healthcare

Explore several modifications introduced in the updated guidelines by the European Medicines Agency regarding computerized systems and electronic data in clinical trials.

Help CROs Choose The Best Software: FDA Guidance On Umbrella Trials

Article | Anju Software

Utilize this guidance as a valuable resource in navigating the evolving landscape of clinical research in innovative and transformative fields.

Advancing Development Of New Oncology Therapies

Webinar | Veristat, Inc.

Learn how the FDA's Project FrontRunner expedites cancer drug approval for early advanced metastatic cancer, emphasizing efficacy and safety in earlier clinical settings.

IQVIA Regulatory Affairs And Drug Development Solutions

Datasheet | IQVIA Safety & Regulatory Compliance

Reduce time, cost, and risk, from discovery through post-registration by employing end-to-end strategic drug development and technology-enabled regulatory services.

OUTSOURCING MODELS

Assessing The 3Cs: Does Your Organization Have The Foundation For Clinical Success?

Guest Column | By Richard Malone, PharmD, MHA, Tanisha Patel, Vincent Puglia, and Renee Riggs

In part one of this series on culture, communication, and collaboration, the authors outline the elements of a strong company foundation and propose an assessment plan to identify strengths and weaknesses.

How CROs Can Deliver A Superior Client Experience

e-book | Sikich

Discover how to properly modernize and streamline the technology solutions that empower client service, research study and project management, and overall operational efficiency.

Key Considerations In Choosing A Technology Partner

Article | Mednet

When choosing a technology partner, CROs should consider the partner's experience in the clinical research industry, ability to meet the CRO's specific needs, commitment to quality, and more.

APAC Biopharma: Bridge The Gap To The US FDA

Brochure | Biorasi

Uncover how these regulatory and partner/outsource services are invaluable for biopharma innovators in navigating the U.S. FDA regulatory process.

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