Newsletter | October 31, 2024

10.31.24 -- Why Site-CRO Relationships Are So Strained — And How To Fix Them

OUTSOURCING MODELS

Why Site-CRO Relationships Are So Strained — And How To Fix Them

The Founder of Empactful Ventures explains the issues that strain site-sponsor relationships and how to resolve them.

Strategies For A More Secure Outsourcing Bottom Line

A panel of experts from across the pharmaceutical/biopharmaceutical industry recently shared their experiences in mitigating financial risk before partnering with a contract research organization (CRO).

Outsourcing Lifecycle Maintenance To A FSP Regulatory Affairs Partner

Explore how an FSP partnership can streamline your regulatory processes, ensuring sustained compliance and efficiency while bringing new drugs or devices to market.

What An Emerging Biotech Should Consider When Selecting A CRO

Better understand how smaller biotech companies should approach CRO selection and what they should consider before launching their clinical development program.

Avance Clinical's Specialist Areas Of Focus

Avance Clinical offers deep scientific expertise and extensive knowledge across a range of specialized therapeutic indications, consistently achieving global regulatory approvals.

REGULATORY & COMPLIANCE

FDA Issues Bioresearch Monitoring Technical Specifications Document To Help You Organize Your Submission

The FDA has issued the latest version of Bioresearch Monitoring Technical Conformance Guide: Technical Specifications Document: version 3.1. This version will likely be in place for a significant length of time as a road map for constructing this part of the NDA or BLA that you submit.

FDA Guidance On The Use Of DMCs In Clinical Trials

Gain an overview of FDA guidance on the use of Data Monitoring Committees (DMCs) in clinical trials and their critical role in safeguarding patient safety and ensuring unbiased decision-making.

Understanding Safety Tactics, Regulatory Considerations In JAPAC

As the Japan and Asia-Pacific region continues to grow as a hot spot for clinical research, pharma companies will need expert understanding of regulatory nuances to ensure compliance.

Clinical Quality Assurance And Compliance Oversight

Explore this tailored assessment and support offerings in clinical quality assurance (CQA) compliance, designed to safeguard adherence to relevant regulations and good clinical practice (GCP).

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You're receiving the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & Compliance. To make changes to your newsletter selections, update your topic preferences.

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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