Six smart ways to speed up clinical trials and reduce risk
Meet Jenni Fulton – Driving Growth and Transformation at Fortrea
Clinical trials are increasingly complex, and even the most well-resourced sponsors and CROs can face unexpected hurdles; whether it’s slow site activation, staffing shortages, or protocol deviations. In these moments, augmenting your trial to help an insourced trial or an existing outsourced trial with support from an experienced CRO collaborator can be the difference between delay and delivery.
Here are six strategic ways to augment your clinical trial with additional CRO support to accelerate timelines and mitigate risk.
1. Site List Augmentation to Expand Reach and Accelerate Enrollment
When enrollment lags or geographic diversity are lacking, a CRO collaborator can rapidly onboard additional sites from their vetted network. These sites often come with master CDAs and CTAs, pre-qualified patient populations and proven operational performance.
Benefit: Faster enrollment, broader reach, and reduced screen failure rates.
Pro Tip: Choose a CRO with global site relationships and experience in your therapeutic area to enable alignment with your protocol and regulatory needs.
2. Clinical Staffing Augmentation to Fill Gaps Quickly
Staffing shortages, whether due to turnover, expansion, or unexpected demand, can stall progress. CROs can provide trained clinical research associates (CRAs), study coordinators, and project managers to fill gaps without compromising quality. Some CRO’s can even offer staffing support at sites.
Benefit: Maintains trial momentum and enables consistent monitoring and data integrity.
Pro Tip: Look for global CROs with flexible staffing models and rapid deployment capabilities.
3. Regulatory and Quality Consulting to Navigate Complexity
Regulatory landscapes are constantly evolving. CROs with deep regulatory knowledge can offer consulting support to help with submissions, compliance audits, and inspection readiness.
Benefit: Reduces risk of delays due to regulatory missteps and improves submission quality.
Pro Tip: Choose a CRO who has regulatory consultants who you can engage early to review protocol and submission strategy before first patient in (FPI).
4. Protocol Optimization and Feasibility Support
A CRO can provide feasibility assessments and protocol consulting to identify operational risks before the trial begins. This includes evaluating visit schedules, data collection burdens, and site capabilities.
Benefit: Fewer amendments, smoother execution, and better patient retention.
Pro Tip: Use feasibility data from the CRO’s previous trials to benchmark and refine your protocol.
5. Technology Integration and Data Management Support
CROs often bring specialized technology platforms for EDC, CTMS, eTMF, and remote monitoring. They can also provide data management teams to enable clean, timely data delivery.
Benefit: Improves data quality, reduces reconciliation delays, and supports real-time decision-making.
Pro Tip: Enable interoperability between your systems and the CRO’s platforms to avoid data silos.
6. Risk-Based Monitoring and Oversight Support
CROs can augment your monitoring strategy with centralized analytics and risk-based monitoring (RBM) frameworks. This allows for targeted oversight and early detection of issues.
Benefit: Enhances compliance, reduces monitoring costs, and improves trial oversight.
Pro Tip: Ask your CRO to provide dashboards and KPIs that align with your internal governance model.
Final Thoughts
Augmenting your clinical trial with support from a CRO isn’t just a contingency plan, it’s a strategic lever to improve speed, quality, and resilience. Whether your augmentation supports an insource or an existing outsourcing strategy, the right CRO collaborator can help you navigate complexity and deliver results.
Fortrea Overview
Fortrea (Nasdaq: FTRE) is a leading global clinical research organization (CRO) dedicated to providing innovative clinical development solutions to the life sciences industry. With over 30 years of clinical research experience, Fortrea has evolved from Covance and Labcorp into a pureplay CRO built for biotech, biopharma, medical device and diagnostic innovators.
Fortrea collaborates with both emerging and established companies to deliver agile, fit-for-purpose full service (FSO), functional service (FSP) and hybrid solutions. Fortrea provides comprehensive Phase I-IV clinical trial management, clinical pharmacology, and consulting services, backed by deep experience in more than twenty therapeutic areas.
Operating in approximately one hundred countries, our diverse and talented team brings scientific rigor, operational excellence, and a strong investigator site network to every trial. By combining the best of our legacy experience with forward-thinking innovation, Fortrea brings predictability to clinical trial execution and helps transform aspirations into outcomes.
Together, exceptional is possible.
Learn more at Fortrea.com and follow us on LinkedIn and X (formerly Twitter).
References:
- Marken - Clinical Trial Site Augmentation: Bridging Research Gaps https://www.marken.com/learning-center/clinical-trial-site-augmentation/. Explains how site augmentation accelerates enrollment and improves trial efficiency.
- MedCity News - How Site Augmentation Enhances Trial Success https://medcitynews.com/2025/01/bridging-clinical-research-gaps-how-site-augmentation-enhances-trial-success/Discusses operational benefits and flexibility of site augmentation models.
- Drug Discovery Trends - Understanding Protocol Optimization in Drug Development https://www.drugdiscoverytrends.com/complexitys-counterpoint-understanding-protocol-optimization/ Explains why protocol optimization reduces amendments and accelerates timelines.
- Applied Clinical Trials - Collaborative Strategies for Technology Integration in Clinical Studies https://www.appliedclinicaltrialsonline.com/view/collaborative-strategies-technology-integration-clinical-studies Covers technology adoption and data management best practices in modern trials.