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When a clinical trial falls behind schedule, enrollment often gets the blame. But many delays begin months earlier. Protocol development, trial design, regulatory planning, vendor coordination, site startup, database validation, and evidence strategy can all affect whether your study stays on track. Learn 11 reasons clinical trial delays often originate before the first patient is enrolled.

The decisions you make before enrollment can affect more than your clinical trial timeline. Endpoint selection, intended regulatory claims, the competitive landscape, CMS review timelines, and reimbursement objectives can influence the evidence your study needs to generate. See what sponsors should consider during study planning and startup.

Is your clinical trial actually ready to launch? A finalized protocol is only one part of study readiness. Before enrollment begins, sponsors need FDA alignment, statistically sound endpoints, complete study documentation, qualified sites and partners, appropriate oversight, and systems designed to generate reliable data. Our Clinical Trial Readiness Checklist helps you identify what’s ready, what’s still in progress, and what could become a bottleneck during study startup. Download the checklist and assess where your study stands.

The first 90 days with a CRO can set the trajectory for your entire clinical trial. Long before the first patient is enrolled, your CRO should be helping turn clinical strategy into an executable study. That means more than scheduling meetings and checking off startup tasks. During those first months, sponsors should expect to see: • A comprehensive kickoff meeting and clear alignment on study goals • A detailed study startup Gantt chart with milestones, dependencies, and ownership • Protocol development with clinical, regulatory, statistical, and operational input • CRF and informed consent form development • Site selection criteria finalized and prospective sites evaluated • Monitoring, safety, and data management plans developed • Regulatory and IRB activities coordinated with the broader startup timeline • Database and data management activities progressing toward enrollment readiness • Consistent communication about progress, risks, decisions, and next steps Just as important is HOW that work gets done. Strong CRO partnerships depend on attention to detail, cohesion across workstreams, experienced expert and management involvement, transparency, and proactive communication. Sponsors should know where their study stands, what needs to happen next, and where potential risks could affect the timeline. Read our latest blog for a breakdown on what sponsors should expect during the first 90 days of working with a CRO and what a well-managed study startup should accomplish: https://lnkd.in/dnvrubmw Planning an upcoming clinical trial? Schedule a no-cost consultation to discuss your clinical trial roadmap: https://lnkd.in/eDhMjRFF #ClinicalTrials #ClinicalResearch #CRO #ClinicalOperations #MedicalDevices #MedTech

Is your clinical trial actually ready to launch? A finalized protocol is only one part of study readiness. Before enrollment begins, sponsors need FDA alignment, statistically sound endpoints, complete study documentation, qualified sites and partners, appropriate oversight, and systems designed to generate reliable data. Our Clinical Trial Readiness Checklist helps you identify what’s ready, what’s still in progress, and what could become a bottleneck during study startup. Download the checklist and assess where your study stands.

Preparing for clinical trial startup? Know what needs attention before it becomes a problem. Our Clinical Trial Readiness Checklist provides a practical framework for evaluating seven key areas of study readiness, including: • Study strategy and FDA alignment • Essential study documentation • Sites and study leadership • CROs, vendors, and data infrastructure • Safety and study oversight • Regulatory and IRB approvals • Enrollment readiness Download the checklist to identify gaps and focus your team’s attention on the activities that could affect startup timelines.