Accelerated study start-up
From feasibility through site activation, speed and precision at every step
From feasibility through site activation, speed and precision at every step
Accelerating study start-up requires a coordinated blend of expertise, technology, and execution. From early feasibility to full site activation, ICON delivers the operational excellence sponsors need to shorten timelines and meet key milestones. Our services are backed by a global team of experts, award-winning tools, and deep data insights, enabling faster decision-making and improved predictability across your trial.
When ICON leads site identification and start up, sponsors benefit from:
-
53%
reduction in median site identification time -
50%
reduction in non-enrolling sites -
25%
higher likelihood of meeting First Patient In (FPI) targets -
21%
higher likelihood of meeting Last Patient In (LPI) targets
Feasibility: Data driven decisions-making
Feasibility is a critical early milestone that determines how your study will progress. Our feasibility experts combine clinical trial intelligence, medical informatics, regulatory data and investigator insights to recommend the most viable path forward. Data sources include:
- Global performance metrics on enrolment speed, site quality and compliance
- ICD-10 claims data in the US from Symphony Health
- Regulatory intelligence to assess country-specific readiness
- Structured outreach with investigators via surveys and interviews
We develop tailored online surveys and interview guides in collaboration with therapeutic experts to gather protocol-specific feedback, assess enrolment potential and ensure alignment with regional standard of care.
Site identification: Targeted and qualified
Our dedicated Site Identification Team operates at both country and global levels, offering a single point of contact through the process. We work closely with sponsors to:
- Develop and execute a customised site identification plan
- Leverage OneSearch to generate a targeted list of high-potential sites
- Manage CDA and questionnaire distribution and collection
- Recommend investigator-qualified sites for pre-study site
With this approach, we consistently drive reductions in non-enrolling sites and help sponsors achieve their recruitment goals faster.
Study start-up: Streamlined and efficient
With regulatory requirements and documentation growing more complex, study start-up can easily become a bottleneck. ICON combines process discipline with leading technology to compress timelines and reduce risk. Benefits include:
- Nearly 2 months faster start-up
- Over 98% of LPI milestones met
- 50% faster site activation times
- Critical Document Pack (CDP) quality tracking and root cause analysis, with error rates as low as 0.1%, well below industry benchmarks
- Site contracting efficiency and milestone oversight
Site activation: Accelerated without compromise
We understand that delays in site activation can lead to missed recruitment goals and increased financial exposure. Our methodology focuses on:
- Rapid site selection with a 20% overage strategy to activate only the top performers
- Streamlined contract negotiations that reduce cycle times
- Lower financial risk - ICON funds start-up activities for additional sites until activation, to reduce disruptions
- Earlier access to critical study data for faster decision-making
For large pharma
Your global development programmes require speed, scale, and consistency. We bring operational discipline and advanced analytics to help you achieve faster FPI, reliable LPI, and predictable enrolment outcomes across geographies. Our team provides strong governance, mature processes, and regulatory expertise to manage complexity and ensure efficiency.
For biotech
Our tailored support model helps resource-constrained biotech sponsors move swiftly and confidently through study start-up. We offer hands-on guidance, transparency at every stage, and flexible solutions designed to meet aggressive timelines while ensuring patient safety and data integrity. Whether you're running your first clinical trial or scaling up a pipeline, our team is with you every step of the way.
Technology that drives smarter, faster decisions
One Search: AI-powered site identification
One Search is ICON’s proprietary site selection system that integrates and analyses billions of data points and trillions of data connections to identify the right sites the first time.
One Search uses human insight and artificial intelligence to identify the best sites based on ICON and industry knowledge, enabling faster, smarter site identification decisions, that result in higher enrolment rates and better site performance.
HORIZON: Advanced study start-up
HORIZON is your command centre for study start-up. It provides real-time visibility into site progress, improves control over activation milestones, and enables earlier risk detection. By giving sponsors and study teams a shared view, HORIZON helps keep your study on track.
SmartDraft: Intelligent site contracting
SmartDraft uses AI to simplify the contracting process. It analyses historical agreements to surface appropriate precedent clauses, helping ICON negotiators craft accurate site contracts faster. The result is fewer negotiation cycles, less back-and-forth, and faster site activation.
Firecrest: Global site portal
Firecrest is the industry’s most widely used site portal, trusted by over 500,000 users across 143 countries. Supporting more than 2,000 studies to date, Firecrest provides a central platform for training, document sharing, and study communications. With a global footprint of 31,000+ sites, it ensures consistency and efficiency from protocol to closeout.
