Newsletter | January 30, 2025

01.30.25 -- Is Clinical Research Inclusive Or Extractive?

OUTSOURCING MODELS

Is Clinical Research Inclusive Or Extractive?

Pulling from the concept of "inclusive" and "extractive" discussed in recent coverage of research conducted by Nobel Prize in Economics winners, Eduardo F. Motti discusses the give and take in the clinical trials industry.

Executive Q&A With SGS' Hudson, NH Bioanalytical Services Facility

Explore how SGS's Hudson facility can enhance your drug development process by providing cutting-edge bioanalytical testing solutions and seamless global support.

Meeting 100% Recruitment 7 Months Ahead Of Schedule

Uncover the detailed outcomes of this extensive Phase 3 clinical trial on a new biosimilar for non-small cell lung cancer.

Non-Ophthalmic Phase 3 Trials With Point-Of-Need Eye Assessments

Collaboration was key for Company W to overcome challenges with an FDA-mandated ocular substudy, including limited resources for ocular assessments and logistical difficulties

Advancing Your Solid Tumor Trials With A Cutting-Edge Assay Portfolio

Advance your oncology trials with central and specialty laboratories with expertise in specialized assays such as next-gen sequencing, flow cytometry, immunohistochemistry, AI in image analysis, and more.

REGULATORY & COMPLIANCE

Can Better Data Management Save Clinical Trials?

In this summary of our 10/31/24 Clinical Leader Live, we talk about the current ICH M11 guideline, which focuses on a clinical electronic harmonized protocol, as well as the need for data standardization and the benefits of the resulting automation. Our panelists include Jessica Jolly, a data science expert with 25 years of experience, and Hassan Kahlid, senior engineer, machine learning and data science at AstraZeneca.

Prepare Now For The FDA's Program For Rare Disease Drug Developers

Delve into this overview of the START pilot program, expectations to consider if you are applying to the program, and early preparation considerations.

Reporting To The IRB: Investigator Noncompliance

Reporting noncompliance concerns is crucial to protect research participants, allowing researchers can ensure ethical research conduct and protect the rights and welfare of participants.

Aligning New Cancer Therapies With FDA Project FrontRunner

Explore questions about the FDA’s Project FrontRunner, including what the project entails, trial design considerations and implications, and the impact on patient safety and site participation.

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  • 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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