Expediting study start-up: Best practices for sponsors

Study start-up is a critical stage of the drug development process and can have a major impact on trial timelines, budgets, and overall success. Start-up activities include steps such as site selection and initiation, regulatory and ethics submissions, and patient recruitment planning. Several factors can impact the speed of study start-up, such as the complexity of protocols and budget negotiations with sites. 

The study start-up process takes an average of four to six months for non-cancer clinical trials, with multi-center studies taking significantly longer than single-center studies. Despite industry investment, there are still major inefficiencies: nearly 11% of sites selected are never activated, and 30–40% of sponsors and contract research organizations (CROs) report being unsatisfied with their current site initiation and start-up processes. 

Precision medicine trials are particularly complex, and there is increasing pressure to accelerate start-up while maintaining compliance and data quality. In this blog, we outline best practices for expediting study start-up to improve trial efficiency and deliver therapies to patients faster.

Best practices to expedite study start-up

Engage sites early with structured feasibility and clear expectations. One of the clearest findings across studies is that early engagement with sites shortens activation timelines. Feasibility reviews that openly address site capacity, staffing, and required resources reduce the risk of later delays. Delays most often occurred in the first two stages of start-up, when sites and sponsors were still clarifying requirements for documentation, budgets, and IRB submission. Academic centers that invested in proactive education, such as regulatory resource libraries and training sessions for investigators and coordinators, reported progressively faster approval cycles over time.

Setting expectations is equally critical. Sponsors that share detailed guidance on expected turnaround times for essential documents, budget negotiations, and IRB queries can prevent sites from falling behind during activation. When sites understand the sequence of activities, the specific documentation required, and how long each step should take, they are better able to allocate resources. This clarity reduces rework, cuts down on back-and-forth communication, and helps shorten the overall cycle.

Build and leverage strong site relationships. Cycle times are almost 10 weeks shorter for repeat sites compared with new sites, underscoring the importance of robust site relationships and long-term planning. Familiar sites bring efficiency due to historical knowledge of processes and performance, while new sites often require more extensive onboarding and education. Sponsors should balance repeat partnerships with deliberate investment in new site relationships to broaden patient access without sacrificing speed.

Address site capacity and contracting bottlenecks proactively. Site capacity constraints remain one of the most significant headwinds for start-up. Recent surveys found that 26% of sites declined trials due to capacity challenges, and 49% declined because investigator grants were insufficient relative to rising site costs. Budget negotiations and stretched site staff also extend contracting timelines. Early budget realism, streamlined contract language, and standardized templates can reduce these delays.

Run regulatory and contracting workflows in parallel. Avoid strictly sequential steps by running regulatory submissions, contracts, and budget negotiations in parallel. Using central IRB/ethics review where available has been rated “very or somewhat effective” by 94.5% of sponsors and CROs, while 90% cite standardized contracting as a top accelerator.

Invest in technology that reduces site burden. While 80% of organizations that have adopted technology report time savings, most still note that tools need improvement. Platforms such as site portals, feasibility modules, and standardized document libraries can improve transparency, reduce duplicate requests, and streamline activation. However, integration of new technology must be paired with strong site support and training.

Plan realistic timelines with data-driven benchmarks. Sponsors should benchmark timelines against empirical data (such as a median 157 days for single-center studies vs. 214 days for multi-center studies) to set realistic expectations and manage variance proactively.

Conclusion

Study start-up remains one of the most persistent bottlenecks in clinical development. However, sponsors that engage sites early with education and expectation-setting, build repeat relationships to capitalize on efficiency gains, proactively address contracting and capacity barriers, and invest in streamlined technology are best positioned to accelerate timelines. By applying these best practices consistently, sponsors can reduce delays, improve site and patient experience, and bring therapies to patients faster.

To explore strategies for enhancing site engagement, download our guide Empowering clinical trial sites to drive innovation in precision medicine.