Clinical trial readiness is an essential part of keeping the many people who participate in clinical trials safe while ensuring the trial runs smoothly, remains in compliance, and stays within budget.
Clinical trial readiness has to do with building systems within a clinical trial that better prepare all project staff for the challenges and responsibilities they will face during the trial. Readiness can relate to sites, staff, and even patients — and its impact can be monumental.
The COVID-19 pandemic has forced clinical research to make bold changes to survive. Pharma Initiatives’ Mark Shapiro joined ArcheMedX to discuss what changes are temporary – and what will be true disruption.
Interview: One ClinOps Leader Tells His Story on Site Preparedness, and Offers the Industry Some Advice
There are many ways a clinical trial can go wrong: There might be delays in site identification, initiation, or patient enrollment. There could be high initial screen failure rates or improperly enrolled subjects. Procedural errors like those related to randomization, dosing, or clinical test implementation might occur.
[Interview] Keeping It Personal: CRO Executive Uncovers the Value of Analytics in the Management of Clinical Trials
Your trial is about to go live – and given the months (or years) that have gone into planning, site selection, and site start-up – you pause to ask yourself whether your sites or staff are ready?