Newsletter | March 13, 2025

03.13.25 -- Should You Choose An FSP Model? It Depends…

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Webinar: Who’s In Charge of Your Trial? How to Ensure Effective Oversight and Leadership

Clinical trials in complex therapeutic areas require more than just a solid strategy—they demand proactive and engaged operational leadership from the sponsor side. Join our expert panel to discuss how an active and knowledgeable Clin Ops lead, in collaboration with an experienced outsourcing project lead, can drive informed decision-making, enhance efficiency, and ultimately ensure trial success. Click to learn more.

OUTSOURCING MODELS

Should You Choose An FSP Model? It Depends…

Small biotechs are often drawn to an FSP model because they believe it’s a less expensive option as compared to an FSO. But that’s not always the case, says Réne Stephens of Danforth Advisors, who gives some examples of what to consider before making your choice of outsourcing solution.

Cold Chain Logistics And Packaging Considerations For Probiotics

Choosing the right packaging partner for your probiotic may be the most crucial step to ensuring your product is safe and potent when it reaches the consumer.

The High Cost Of CRO Turnover (And How You Can Avoid It)

Though some turnover is an inevitable part of a business’s life cycle, there are several strategies available to ensure a consistent CRO team throughout the span of your trial.

Optimizing Early-Stage Oncology

A strategic partnership enables a U.S. biotech company to address the struggles with their Phase I first-in-human oncology trial.

A People-First Culture: Are You Ready To Make An Impact?

With a focus on small and mid-sized biopharma companies, this premier CRO specializes in delivering innovative solutions in oncology and infectious diseases.

Orphan And Rare Disease CRO Services

Rare Disease clinical studies demand a specialized full-service CRO with expertise in enrollment, site selection, and global regulatory knowledge, including access to patient registries.

REGULATORY & COMPLIANCE

Breaking Down The FDA's Latest Guidance On Electronic Systems In Clinical Investigations

In October, the FDA took a significant step forward by releasing a new Q&A guidance clarifying the use of electronic systems, e-records, and e-signatures in clinical investigations.

Analyzing The FDA's Approach To Diversity In Clinical Trials

Learn how utilizing diverse data resources and collaborating with stakeholders enables sponsors to foster a culture of inclusivity, meet regulatory requirements and ultimately advance medical science.

Pioneering Strategies For Early Phase Oncology Trials

As the field advances, adaptive methodologies and regulatory shifts redefine early-phase oncology trials, promoting efficiency, flexibility, and equitable access.

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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