GUEST COLUMNISTS

• The Art And Skill Of Caring For Terminally Ill Patients In Clinical Research And Beyond

  When designing and conducting trials for terminally ill patients, Kamila Novak reminds researchers to act and speak with respect, warmth, and thoughtfulness.

• What The FDA's Latest Move On Psychedelics Means For Non-Hallucinogenic Drug Sponsors

  Taking another angle to the FDA focus on psychedelic research, Enveric Biosciences CEO Joseph Tucker, Ph.D., explores what the FDA’s moves mean for non-hallucinogenic drug sponsors.

• 5 Signs Your Clinical Trial Needs Outside Help

  Could you use some outside help? The right outside partner can bring the expertise, capacity, and perspective needed to get studies back on track.

• What The FDA's Psychedelic Drug Focus Means For Classic Psychedelic Development

  Complementing an interview with Enveric Bioscience's Joseph Tucker, Ph.D., this Q&A explores Josh Hardman's thoughts on what FDA’s psychedelic focus could mean for classic psychedelic development.

• The Patient Advocacy Strategy Behind Skyhawk's Rapid Enrollment

  Skyhawk’s patient-first approach shows how advocacy partnerships, site engagement, and operational quality can accelerate enrollment without losing focus on patients.

• How FDA Alignment Is Shaping Opus Genetics' OPGx-LCA5 Development Strategy

  Opus Genetics shares how FDA alignment yielded a clearer path for its ultra-rare LCA5 gene therapy, shaping trial design, evidence generation, and operations.

• Why Vendor Oversight Breaks Down At Handoffs

  Is a vendor handoff really complete once the file is sent? Not quite. Sponsors still need context, ownership, and evidence to keep trials moving.

• Don't Accept This Site-Level Start-Up Bottleneck— Instead, Learn How To Stop It

  Combining investigator meetings and SIVs can cut site activation timelines in half — if sponsors build a compliance-sound case and involve QA early.