Newsletter | August 28, 2025

08.28.25 -- When To Outsource — And How To Pick The Perfect Clinical Trial Partners

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

When To Outsource — And How To Pick The Perfect Clinical Trial Partners

EMED Technologies Director of Clinical Affairs Alex Nikanorov shares the company’s approach to deciding which clinical research functions to outsource and finding vendor partners that align with the company’s goals.

Accelerated Peptide Drug Development And Clinical Strategies

Review how an integrated platform approach and innovative filtration strategies helped bring a novel therapeutic to Phase 1 clinical trials with reduced time and costs.

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.

CRO Enhances Security And Participant Payments Workflow

A leading full-service CRO, managing over 250 studies annually, faced significant challenges with participant payments.

New Purpose-Built Facility For Large-Scale Sterile Fill/Finish Operations

Expanding capacity for late-phase clinical and large-scale commercial small molecule and biologic drugs, a new facility boosts sterile fill/finish capabilities.

Optimizing EDC Strategy And Data Collection for a Rare Disease Trial

Explore how Veristat created a forward-looking roadmap for EDC and CRFs integration for a small biotech sponsor, ensuring a future-ready data ecosystem without overcomplicating current operations.

REGULATORY & COMPLIANCE

Celebrating Clinical Trials Day, Part 2: Trial Optimization In Action

Celebrate Clinical Trials Day 2025 with these industry experts as they share experiences and advice related to trial design, regulatory and compliance, and outsourcing challenges.

Validating Generative AI: A Framework For Reliability And Compliance

With structured CSA-driven validation and expert guidance, organizations can harness generative AI’s advantages safely and effectively, ensuring accuracy, compliance, and operational excellence.

All You Need To Know About 505(b)(2), But Were Afraid To Ask

Join us to explore the 505(b)(2) pathway. Learn how to bring improved drugs to market faster, reduce costs, and add value with this streamlined regulatory approach.

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.

Why Regulatory CMC Strategy Is Crucial To Drug Development Projects

Our goal is to provide comprehensive Reg CMC strategic advising that not only aligns with regulatory expectations but also enhances the efficiency and success of your drug development efforts.

Promotional Materials And Compliance Activities

Learn more about comprehensive services for global promotional material review, compliance, and validation tailored to the needs of pharmaceutical and medical device companies.

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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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