Newsletter | September 11, 2025

09.11.25 -- You Just Secured $50 Million. Now On To The Hard Part: Clinical Trials

SPONSOR

Smart Sourcing: IRT/RTSM Technology Showcase

Join us on September 24, 2025, for a free virtual expo tailored to clinical teams evaluating IRT/RTSM platforms. Get live 15-minute demos, real-time Q&A, and side-by-side comparisons from top vendors. Ideal for Clinical Ops, Trial Supply, Data Management, and Procurement professionals, this event helps accelerate vendor selection and streamline study planning.

OUTSOURCING MODELS

You Just Secured $50 Million. Now On To The Hard Part: Clinical Trials

4C Associates' life sciences director Tom Wells explores common pitfalls of early-stage biotechs' transition into clinical trials and shows how early involvement of sourcing professionals can improve delivery, control spend, and help retain oversight.

A Biologic Drug's Analytical Journey

Gain valuable insights into advanced methods and analysis techniques for high-order structure, physiochemical characterization, cell-based and biochemical assays, and more.

The Defensiveness Trap In Vendor Selection And Management

In clinical research, sponsor–vendor relationships are often framed as negotiations. Yet while both sides want to achieve a successful study, the process often becomes a tug-of-war.

Leverage Functional Service Providers For Drug Development Efficiency

Discover how functional service providers (FSPs) are reshaping clinical research by offering specialized expertise, flexible resources, and cost-effective solutions.

Accelerate Formulation Development For Poorly Soluble Drugs

Explore how a platform integrating drug substance, drug product, and clinical testing within a single organization accelerates development and reduces costs, helping deliver positive outcomes earlier.

Start Strong And Keep Your Study Moving

Plan face-to-face, virtual, and hybrid life sciences events with precision using an end-to-end service that plans everything from investigator meetings to advisory boards and incentive trips.

When Clinical Trials Drift Off Course

Recovering lost clinical trials is an art. Learn how we triage your study’s problem areas, build recovery strategies to address your drifting trial’s performance, and deliver results.

Accelerate Your Drug Development With A Global Partner

With the right Chemistry, Manufacturing & Controls (CMC) consulting services, your organization can excel in early-stage strategizing, accelerate timelines, optimize processes, and reduce costs.

SPONSOR

Webinar: Ensuring Compliance in Gene Therapy Trials for Neurological Disorders: IRB and IBC Perspectives

Gene therapy research for neurologic disorders presents distinct ethical, regulatory, and biosafety challenges, particularly with vulnerable populations. In this BRANY webinar, IRB and IBC experts, along with a medical ethicist and neurologist, share insights on nuanced consent, caregiver considerations, and oversight. Sponsors, CROs, investigators, and review boards will gain guidance to navigate these complex trials. Click here to learn more.

REGULATORY & COMPLIANCE

How Digital Twins Are Rewriting Clinical Trials

While the benefits of digital twins to accelerate clinical trials are undeniable, many questions about their use are still unanswered and go far beyond technology.

Best Practices For Gene Therapy BLA/MAA Submissions

Medical writers completing gene therapy submissions require strategic placement, justification, and cross-referencing to fit unconventional data within a standard template.

How PIE Streamlines Biopharma And Payer Communication

Navigating pre-approval information exchange (PIE) with healthcare decision-makers is essential for market success. Learn what information can be shared and the best strategies for communication.

Europe Has A Platform For Driving More Flexible Clinical Trials

Despite recent setbacks, Europe possesses inherent strengths in clinical research, and a concerted effort is needed to transform its potential into a thriving and competitive environment.

Driving Safety And Compliance Seamlessly

Whether it’s accelerating market entry with the “FSP Country in a Box” solution or maintaining global compliance through expert oversight, IQVIA empowers organizations with scalable, localized support.

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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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