Partnering & Outsourcing Editorial

  1. How PDS Biotech Approached FDA Meetings For Its Phase 3 Cancer Trial 2/11/2025

    PDS Biotech CMO Kirk Shepard reveals his team’s interactions with the FDA as it sought to begin its Phase 3 trial for the treatment of HPV-positive recurrent and/or metastatic head and neck squamous cell carcinoma.

  2. Biopharma R&D Faces Productivity And Attrition Challenges In 2025 1/29/2025

    Evaluate VP of Thought Leadership Daniel Chancellor discusses trends for 2025 as the surge in R&D, coupled with rapidly evolving industry dynamics, presents a productivity and attrition challenge for the industry.

  3. Tech Vendors Are Today's Don Quixotes 1/28/2025

    Don Quixote is known for tilting at windmills, believing them to be enemies. Today, it seems, emerging tech solution developers are embodying the spirit of the quixotic knight centuries later.

  4. Should You Choose An FSP Model? It Depends… 1/10/2025

    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.

  5. Why Hire An Interim Chief Medical Officer? 1/6/2025

    Chief medical officers can drive substantial progress while still being cost-effective additions to a clinical team. Boyds CMO Karen Mullen, MBBS, FRCP, FFPM, GFMD discusses the value of an interim CMO.

  6. Is Clinical Research Inclusive Or Extractive? 12/6/2024

    Pulling from the concept of "inclusive" and "extractive" discussed in recent coverage of research conducted by Nobel Prize in Economics winners, Eduardo F. Motti discusses the give and take in the clinical trials industry.

  7. Were There Any Surprises In Clinical Trials In 2024? 12/4/2024

    Is it any surprise that when I asked a group of clinical trial industry experts to summarize some of the things that stood out to them in 2024, that AI would be mentioned more than once? Probably not. Resistance to DCTs, increasing regulatory scrutiny, and a slowdown in CRO M&As also made their lists — but I’m guessing none of that surprises you, either.

  8. Site Capabilities — The Hidden Drivers Of Clinical Trial Success 11/26/2024

    We've overcomplicated site selection, says Stryde Research CEO Chintan Desai. Here, Desai details what qualities sponsors should really look for in sites and why some of our existing criteria aren't cutting it.

  9. CRO Summit Chair Muses On The Future Of CROs 11/13/2024

    Clinical Outsourcing Group CRO Summit Chair and seasoned biopharma CxO Jasmina Jankicevic shares her insights on the evolving landscape of CROs. 

  10. With The State Of CRO Monitoring, Industry Must Course Correct 11/11/2024

    When a sponsor outsources monitoring, it is outsourcing QC. But is that a good thing? PDC Pharma Strategy CEO Penelope Przekop explains why sponsors might want to reconsider its decision to outsource clinical trial monitoring.