Newsletter | January 8, 2026

01.08.26 -- The 2020 Pediatric Mandate That Shook Up Oncology Research

OUTSOURCING MODELS

'Country In A Box' And Other Smart Outsourcing Moves

Jeremy Weitz breaks down the “country in a box” approach — a flexible FSP model that lets sponsors operate efficiently in countries where they lack a local footprint.

Strategies For A More Secure Outsourcing Bottom Line

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

5 Questions That Put Sponsors Back in Control of Bioanalysis Projects

Bioanalysis service quality significantly impacts project success. Don't settle for typical CRO claims. Demand better technology, pricing transparency, and dedicated partnership.

The Rescue Option: Course Correcting Struggling Clinical Trials

The willingness to seek expert support from Rescue CROs when clinical trials face critical challenges is not a sign of weakness but a demonstration of accountability and commitment to excellence.

Reframing Vendor Selection: Beyond Price And Past Relationships

An RFP is more than a budget tool — it’s a strategic communication document that guides vendors, clarifies expectations, and enables informed, data-driven sponsor decisions.

Unlock Robust And Reliable Stability Data With The Right Partner

Stability testing is essential to ensuring your drug’s stability, potency, efficacy, and safety under different controlled conditions throughout development, manufacturing, and life cycle management.

Delivering Trials With Consultation And Management In Cancer Research

The rapidly evolving landscape of oncology clinical trials, driven by innovative technologies and deeper insights into cancer biology, presents unique challenges and opportunities for U.S. biotech companies.

Clinical Research Services For Early Phase Drug Development

Drive your program forward with an experienced partner ready to execute early-phase clinical research with exceptional speed and scientific rigor.

Advanced Aseptic Filling Line: Vials, Syringes, And Cartridges

See how a cutting-edge, multi-purpose isolator line delivers high-speed, precision fill/finish. This flexible technology supports a diverse range injectable therapies.

Bioanalysis Solutions

Learn how a bioanalytical testing partner with comprehensive solutions and unwavering commitment to quality can help you bring safe and effective drugs to market with confidence.

SPONSOR

Clinical research sites aren’t just execution engines. They’re the quiet architects of tomorrow’s medicines, building trust one patient at a time, solving problems no protocol can predict, and keeping trials alive when everything else wants to slow them down. Save Our Sites exists for one purpose: to build sites to last. If you’re ready to stop patching and start building something enduring… This is the conference for you. One industry. One community. Shared solutions.

REGULATORY & COMPLIANCE

The 2020 Pediatric Mandate That Shook Up Oncology Research

Until 2020, the majority of drugs used in pediatric medicine had not been studied adequately in children. Expert Bhargavi Pandit recounts the impact the U.S. RACE for Children Act had on pediatric and adult investigational drug trials.

MHRA International Recognition: Fast-Track UK Market Access

MHRA’s IRP accelerates UK approvals via trusted regulators, but faster authorization only translates to access when aligned with NICE evidence needs, pricing policy, and coordinated launch strategy.

Clinical Trial Disclosure Fundamentals

Failing to comply with disclosure rules can leave sponsors open to fines and penalties. We present the latest disclosure requirements, enforcement mechanisms, and tips on how best to stay compliant.

Transforming Medicine: Strategies In CGT Development

By prioritizing adaptive trial designs and strategic logistical planning, developers can overcome significant barriers to accelerate the delivery of transformative treatments to patients.

Trusted Partner For Clinical And Regulatory Success

Find customized, end-to-end clinical and regulatory solutions, guiding biotechnology, pharmaceutical, and medical device companies through the entire product lifecycle.

SPONSOR

Live Event: The FDA Year in Review — And What Comes Next

The FDA didn’t sit still in 2025, and neither can you. Our industry insider panelists will cut through the noise to explain which regulatory shifts, guidance updates, and inspection trends really matter for clinical trials in 2026 — and what you should do about them. Click here to learn more.

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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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