Newsletter | March 20, 2025

03.20.25 -- With The Rise Of PAOs And Site Networks, What Will The CRO's Role Be?

SPONSOR

Webinar: Inspection Readiness for Decentralized Trials: Lessons from FDA Inspection of Pivotal DCT study

DCTs enhance accessibility by reducing participant burdens like travel and costs. Join us for an overview of a study using DCTs, focusing on the central and local Principal Investigator (PI) roles. Delve into preparations for inspections, including BIMO checklist references, PI interview guidelines, record-keeping requirements, and inspection process details such as agendas, oversight, and follow-up expectations. Click here to learn more.

REGULATORY & COMPLIANCE

U.S. Biosimilars Surge: Clinical Trials, Regulatory Shifts, And The Path To Dominance

Guest Column | By Joseph Pategou

Joseph Pategou asks and answers, "Where does the U.S. biosimilar market stand now?"

Navigating IDMP Implementation And Meeting Evolving Requirements

White Paper | By Lalith Mohan Tummalapalli, Amar Tandon, and Ankit Tyagi, IQVIA Safety & Regulatory Compliance

Here, the authors explain why adherence to evolving requirements is essential for marketing-authorization holders (MAHs) to ensure compliance and maintain accurate product information.

Five Steps To Preparing For The PMS Of EMA's SPOR Program

Article | Cencora PharmaLex

Prepare for product management service (PMS) requirements with this 5-step checklist that helps ensure smooth data migration and compliance.

Integrated Strategies for Achieving Regulatory Milestones Faster

Case Study | Quotient Sciences

Learn how an innovative formulation platform reduced development timelines and allowed a sponsor to find the optimal nafamostat formulation without adding unnecessary delays.

GMP Auditing, Compliance, And Specialized Consulting

Brochure | Advarra

Ready to make your research altogether better? Learn how Advarra is assisting clients to reduce risk and ensure adherence to GMP, GLP, and GTP standards.

OUTSOURCING MODELS

With The Rise Of PAOs And Site Networks, What Will The CRO's Role Be?

Guest Column | By Jeremy Weitz, Biogen

In part two of this series, Jeremy Weitz discusses the roles of PAOs and site networks, as well as how CROs are partnering with them, and predicts how CROs might reinvent themselves. 

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

Q&A | By Sujata (Suzzy) Bhavekar, M.S., SGS

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

Late Stage Customization

Brochure | PCI Pharma Services

Learn about the benefits of a late stage customization approach, including how it can support a leaner, more responsive supply chain, ensuring life-changing therapies reach patients more efficiently.

Contract Packaging Services For Probiotics

Product | Ropack Pharma Solutions

Sachet is a packaging format that meets the demands of probiotic consumers and manufacturers alike.

CHOOSE YOUR OWN ADVENTURE

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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