Newsletter | January 9, 2025

01.09.25 -- With The State Of CRO Monitoring, Industry Must Course Correct

SPONSOR

Is it time to turn the page on your trial management practices? Join us Feb. 11-13 for Clinical Leader Solutions Expo: Tech Week as experts across EDC, IRT, and eCOA introduce the latest in technologies. We’ll help you discover whether it’s time to write your next chapter and connect you with the partners ready to help you do so – all from the convenience of your computer. Register today and finish your clinical trials story strong.

REGULATORY & COMPLIANCE

How Will The ICH M11 Guideline Impact Future Clinical Trials?

Hassan Khalid of AstraZenca talks about the impact of ICH M11 guidelines on future clinical trials, specifically after a data lock.

Impact Of sIRB Mandates On Study Teams

Explore the practical implications faced by investigators and their support staff, such as navigating new bureaucratic procedures and adhering to revised regulatory requirements.

The Future Of Regulatory Operations

The pathway to enhancing reliability, compliance, and efficiency across lifecycle management will require embracing technology and process improvement if organizations want to achieve their goals.

Wherever You're Going, Our Regulatory And Access Experts Have Been There

With our consulting team by your side, comprised of over 1,000 dedicated professionals, you can be confident that your treatment’s journey from research to patient care is in expert hands.

SPONSOR

AI is transforming clinical trials — are you ready to harness its potential? Join Clinical Leader Live on January 14th to explore real-world applications of AI that optimize trial design, enhance data analysis, and accelerate timelines. Don’t miss this chance to stay ahead in clinical research! Attendance is free thanks to the support of The PPD clinical research business of Thermo Fisher Scientific.

OUTSOURCING MODELS

With The State Of CRO Monitoring, Industry Must Course Correct

When a sponsor outsources monitoring, it is outsourcing QC. But is that a good thing? PDC Pharma Strategy CEO Penelope Przekop explains why sponsors might want to reconsider their decision to outsource clinical trial monitoring.

Key Considerations For CROs In Choosing A Technology Partner

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.

Strategies For Achieving Regulatory Milestones Faster

Explore how a vendor that offers integrated drug substance, drug product, and clinical testing activities under one organization facilitates improved communication and a more agile approach to development.

Solutions For Seamless Cohort Management & Dose Escalation Studies

Jim Eamma’s experience in scientific and clinical research includes work in academic, clinical, and CRO settings. Jim shares how the team can help with your oncology trials.

Packaging Design And Development Services

We are manufacturing, packaging, and supply chain experts, harnessing experience and expertise to deliver you a seamless solution with the ultimate aim of improving the lives of patients.

CHOOSE YOUR OWN ADVENTURE

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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