Newsletter | October 30, 2025

10.30.25 -- Inside A Micro-CRO's Evolution

SPONSOR

Webinar: How to Select the Right Bioanalysis CRO for your Program

For a biotech company, selecting the right bioanalysis CRO partner can make or break their program timeline. Bottom line: the right bioanalysis CRO becomes a true accelerator; the wrong one slows you down. Join us for an unfiltered examination of bioanalysis CRO selection challenges, red flags to avoid and solutions for securing a bioanalysis partner that matches your program's pace. Register Now.

REGULATORY & COMPLIANCE

FDA Pharma Advertising Crackdown Reshapes Clinical Research, Too

Empactul Ventures' Denise N. Bronner, Ph.D., explores how the FDA's crackdown on pharmaceutical advertising might affect clinical research patient recruitment and engagement.

Writing Effective Clinical Regulatory Documents For Therapy Trials

Clinical medical writing for gene therapy regulatory documents is a demanding, detail-oriented task that diverges significantly from medical writing for more traditional therapies.

The Strategic Advantage of Australia And Asia for U.S. Biotechs

This expert panel explores how Australia, Taiwan, and South Korea provide a strategic advantage in conducting early, mid, and late-phase oncology trials.

Pre-IND CMC Checklist For Regulatory Success

Learn how to prepare CMC documentation that meets regulatory expectations, and explore key elements for a successful Pre-IND submission to avoid common delays in the review process.

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OUTSOURCING MODELS

Inside A Micro-CRO's Evolution

A new generation of micro-CROs is emerging—lean, virtual, and built by experienced ClinOps leaders. Instead of owning infrastructure, they’re renting it, showing that credibility and connections can rival size in today’s contract research market.

Impact Of Supplier Choice On APAC Clinical Trial Execution

Choosing the right clinical packaging and supply chain partner to support APAC studies can vary significantly based upon which countries are involved and the types of services required.

Driving Precision, Agility, Partnership In Complex Drug Development

Anshul Gupte Ph.D., RAC Drugs, VP of Pharmaceutical Development, discusses phase-appropriate development, technical hurdles, building agile teams, and planning strategy for novel therapies.

Bioanalytical Solutions: Discovery PK To Post-Marketing Surveillance

Sujata (Suzzy) Bhavekar, M.S, CSM, shares how SGS's Hudson facility can enhance your drug development process by providing cutting-edge bioanalytical testing solutions and global support.

Drug-Drug Interaction (DDI) Studies

Learn how an innovative development platform with the unique ability to fully integrate DDI studies accelerate timelines and improve the likelihood of downstream success.

From Innovation To Patient Impact

Biotech innovation is redefining the future of healthcare — but translating breakthroughs into patient impact requires the right partner.

Accelerate Your Clinical Trials In Australia

Accelerate your biotech trials in Australia—cut costs by up to 60%, enroll patients in as little as 4–6 weeks, and generate FDA- and EMA-accepted data with no IND required.

Why Functional Outsourcing Is Important To Clinical Development

Learn why functional outsourcing is important in today's clinical development environment and how Catalyst Flex supports this and is scalable to flex to your changing needs.

Your Global CRO Partner In Ophthalmology

Ophthalmic drug and device development demands precision, agility, and deep therapeutic knowledge. Discover how our focused ophthalmology expertise can support your next clinical breakthrough.

SPONSOR

Starting a New Study? This One’s for You.

Choosing the right CRO is one of the most critical decisions in any new study. Clin.AI has helped sponsors facilitate billions in vendor selections, bringing automation and transparency to a process long buried in spreadsheets. Backed by Heads of Clinical Operations and Outsourcing, our platform helps teams compare proposals instantly—saving up to 10% in cost and achieving 8 weeks faster FPI through smarter vendor selection.

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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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