Site Selection, Activation and Support
Driving faster startup and enrollment predictability through data-driven site selection and activation.
Effective site selection lays the foundation for successful clinical trials, directly impacting enrollment timelines, data quality and overall study outcomes. Site activation represents the pivotal transition point when clinical trial planning transforms into active patient recruitment and study execution, making it one of the most critical phases in the research timeline.
Together, these complex processes encompass data driven feasibility, regulatory approvals, staff training, protocol implementation and system setup. Each of these steps requires meticulous coordination to prevent costly delays that can extend study timelines by months.
Accelerating clinical trials with strategic site selection and activation
To identify the best sites for your study, our medical, global site feasibility, Real World Evidence, and operations experts take a data-driven, AI-powered approach to developing a country and site strategy tailored for your study or program.
We use advanced AI-driven prediction models to identify the highest performing sites and pressure test your trial plans using thousands of simulations. This approach ensures we account for every variable—from site activation time to patient enrollment periods and inflight enrollment risks—to give you a clearer roadmap to success.
Site selection for your study will also be informed by the strong, collaborative relationships we cultivate with sites. For example, our Catalyst Site Network is a select group of high-performing sites from across the globe known for their deep expertise, fast startup and strong retention capabilities. The network is therapeutically aligned and includes a variety of sites: individual practices, academic centers of excellence and site networks.
Learn about our next-generation site engagement platform, StudyEngage, and how it centralizes site registration, profile management and feasibility into a single, reusable data source, reducing site burden and accelerating study startup.
Supporting sites with clinical trial regulatory and site startup expertise
Our dedicated Site Activation and Regulatory team is comprised of more than 1,500 subject matter experts who support all aspects of clinical trial regulatory and site startup operations. This includes:
- Site identification/feasibility
- Ethics and regulatory submissions
- Clinical study regulatory submissions strategy
- Site contract and budget negotiations
- Coordination of essential documents collection
- Review and approval of site regulatory packages for investigational product release and the corresponding oversight of those activities
Clinical trial support that goes above and beyond traditional CRO services
Our integrated approach extends far beyond conventional clinical research services, including site augmentation, comprehensive patient engagement and offsite research capabilities.
We can act as an extension of site teams, supporting site-driven trial milestones and outcomes by performing duties of under Delegation of Authority of Principal Investigator to:
- Empower sites with personalized support plans based on peer-led site diagnostic assessments.
- Deploy expert clinical professionals to help sites overcome time and staffing constraints with onsite or remote specialists (e.g., data entry staff, Clinical Research Coordinators, registered nurses).
- Support study start-up with regulatory and activation tasks.
Clinical trial participation should feel seamless. Our Patient Concierge Services are designed to remove barriers and deliver a human-centered experience from start to finish.
We:
- Provide 24/7 multi-lingual support from patients and caregivers, covering scheduling, travel coordination and reimbursements.
- Enable sites to focus on care while we manage logistics and address participant questions.
- Achieve measurable results, with sites that use our Patient Concierge Services achieving 29% higher enrollment.
We bring the trial to the patient, offering flexibility, convenience and continuity of care when the protocol allows for offsite visits.
We:
- Conduct key study activities offsite, including vitals, ECGs, IMP administration, sample collection, symptom-directed assessments, and much more.
- Deploy mobile research nurses trained on protocol procedures, equipped with necessary equipment and supplies
- Maintain protocol compliances and data integrity through accurate e(CRF) completion and adherence to ancillary requirements.
Let’s talk about your clinical trial and strategies to empower sites for better performance and measurable impact.
Site activation timelines can be impacted by several factors, including regulatory and ethics approvals, contract negotiations, site readiness, and staff availability. Delays often occur due to inconsistent documentation, slow budget approvals, or lack of centralized processes. Streamlining communication, using standardized templates, and engaging experienced sites can significantly reduce activation time and improve trial efficiency.
Proven strategies to accelerate site activation include early feasibility assessments, standardized start-up workflows and technology-enabled document management. Clear communication between sponsors, CROs and sites is essential to anticipate regulatory and operational requirements upfront. Leveraging centralized contracting and ethics submissions further streamlines approvals, while dedicated site support teams help resolve issues quickly.
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