In this episode of The Top Line, host Chris Hayden speaks with Olive McCormick, Head of Quality and Qualified Person at Almac Clinical Services about why late‑breaking issues in clinical trials pose such significant risk — and what teams can do to prevent them. McCormick explains that operational misalignment, delayed communication, overlooked regulatory steps or misinterpretation of requirements under the new UK Clinical Trial Regulation can snowball quickly, putting both patient safety and organizational credibility at stake.

She and Hayden discuss how sponsors, CROs and site teams can keep trials on track by establishing strong communication channels and maintaining a unified understanding of responsibilities as studies reach key milestones. McCormick stresses the value of proactive engagement and early insight into potential challenges, noting that waiting too long to identify or resolve issues increases the likelihood of disruptions.

The episode calls on clinical research professionals to prioritize transparency, coordination and shared accountability. Whether you’re leading a trial or supporting one, the discussion offers practical guidance to help teams avoid the preventable setbacks that so often arise near the finish line.

In this episode of The Top Line, host Chris Hayden speaks with Olive McCormick, Head of Quality and Qualified Person at Almac Clinical Services about why late‑breaking issues in clinical trials pose such significant risk &mdash; and what teams can do to prevent them. McCormick explains that operational misalignment, delayed communication, overlooked regulatory steps or misinterpretation of requirements under the new UK Clinical Trial Regulation can snowball quickly, putting both patient safety and organizational credibility at stake.
She and Hayden discuss how sponsors, CROs and site teams can keep trials on track by establishing strong communication channels and maintaining a unified understanding of responsibilities as studies reach key milestones. McCormick stresses the value of proactive engagement and early insight into potential challenges, noting that waiting too long to identify or resolve issues increases the likelihood of disruptions.
The episode calls on clinical research professionals to prioritize transparency, coordination and shared accountability. Whether you&rsquo;re leading a trial or supporting one, the discussion offers practical guidance to help teams avoid the preventable setbacks that so often arise near the finish line.

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&D and device development. Available every Friday morning. 

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&amp;D and device development. Available every Friday morning.&nbsp;

The Top Line

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech and Fierce Pharma recount the latest industry trends and why they matter. We’ll analyze the week’s biggest business news—from mergers and marketing to drug R&D and device development. Available every Friday morning.

 

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech and Fierce Pharma recount the latest industry trends and why they matter. We&rsquo;ll analyze the week&rsquo;s biggest business news&mdash;from mergers and marketing to drug R&amp;D and device development. Available every Friday morning.
&nbsp;

Proactive coordination is essential to protect patients, sponsors and trial integrity, especially as teams navigate the new UK Clinical Trial Regulation. Hear why alignment matters more than ever.