CASE STUDY: Accelerated Site Activation to Maintain Recruitment Targets in a Phase IIa Alopecia Areata Study
Executive Summary
How Stiris accelerated site activation and rapid execution to maintain recruitment targets and study timelines.
Therapeutic Area: Dermatology
Indication: Alopecia Areata (Autoimmune Disease)
Phase: IIa
Location: Canada
Situation: An ongoing Phase IIa alopecia areata clinical trial required additional recruitment capacity to maintain patient enrollment targets and meet critical study timelines. Canada was introduced as a participating country after study initiation, requiring expedited feasibility, site selection, regulatory and ethics submissions, and site activation to avoid delays.
Outcome: All five Canadian clinical trial sites were activated within eight weeks of selection, ahead of the sponsor’s target timeline. Rapid study start-up enabled sites to achieve their patient recruitment goals, supporting on-schedule enrollment completion and helping the sponsor maintain overall study timelines.
Challenge
A North American sponsor conducting a Phase IIa clinical study in Alopecia Areata required additional support to strengthen patient recruitment. As part of a geographic expansion of the study, Canada was added as a new participating country, placing significant pressure on execution timelines given that the trial was already underway.
Rapidly identifying, selecting, and activating high-potential recruitment sites was critical to maintaining the study’s global objectives and avoiding delays against sponsor timelines.
Feasibility, selection, and start-up activities had to be completed within highly compressed timelines to enable patient recruitment as quickly as possible.
The sponsor required a solution that balanced accelerated execution with rigorous site selection, ensuring experienced, recruitment-ready sites were identified without compromising quality.
Solution
Building on an existing relationship with the sponsor, Stiris was selected to lead the Canadian expansion of the study. This established trust enabled work to begin immediately, avoiding many of the delays typically associated with onboarding a new partner. Stiris implemented an accelerated site activation strategy, combining its established site network with streamlined start-up processes, to keep the study on track and meet the sponsor’s compressed timelines.
- Relationship-Driven Site Identification
Stiris leveraged its strong network of site relationships to quickly identify high-performing centers with the greatest likelihood of successful participation. By prioritizing experienced and responsive sites with a proven recruitment track record in the therapeutic area, the team was able to pre-qualify candidates before formal feasibility even began, saving critical time at the outset.
- Streamlined Feasibility & Selection Processes
Feasibility and site selection processes were optimized to eliminate unnecessary delays, with same-day turnaround implemented for critical milestones including site selection decisions. This compressed approach ensured that no time was lost between candidate identification and formal site engagement.
- Expedited Site Qualification Execution
Stiris completed five Site Qualification Visits (SQVs) within just six business days, a pace that demanded precise scheduling, proactive coordination, and a highly responsive field team. Speed was maintained without compromising the rigor of the qualification process, ensuring only sites meeting the required quality standards moved forward to activation.
- Integrated Project Management & Clinical Monitoring
Close coordination between Project Management and Clinical Monitoring ensured that start-up activities progressed in parallel wherever possible, avoiding sequential bottlenecks. This integrated approach allowed Stiris to function as a true extension of the sponsor’s team, with clear communication and shared accountability throughout.
Results
- Ahead-of-Schedule Site Activation
All five Canadian sites were activated within eight weeks of selection, completing feasibility and study start-up activities ahead of sponsor expectations and enabling timely initiation of patient recruitment.
- Enrollment Targets Met
Canadian sites met their patient enrollment targets, directly contributing to the sponsor closing global study recruitment within the planned timeline and without disruption to the overall clinical program.
- Seamless Country Expansion
Canada was successfully integrated as a study country without affecting global clinical program timelines, demonstrating Stiris’ ability to execute complex geographic expansions under significant time pressure.
Sponsor Impact
Stiris successfully supported a North American sponsor in maintaining the momentum of an ongoing Phase IIa Alopecia Areata study under significant time pressure.
Through an accelerated site activation strategy, deep site network relationships, and streamlined start-up execution, Stiris protected critical enrollment timelines, reduced operational risk, and enabled the seamless integration of Canada as a study country, allowing the sponsor to close global recruitment on schedule and without disruption to the broader clinical program.
Key Highlights
- Accelerated site activation without compromising quality.
- Established site network with a proven performance track record.
- Highly efficient feasibility and selection processes.
- Effective coordination between Project Management and Clinical Monitoring.
- Operational flexibility and a solutions-oriented approach.
- Seamless integration with the sponsor’s team, functioning as an extension of their operations.
Need support to accelerate your clinical study?
Do you need to accelerate site activation, strengthen recruitment, or maintain demanding timelines in clinical studies? The Stiris team combines operational expertise, strong site relationships, and agile execution to help sponsors achieve their clinical development objectives. Contact us to learn how we can support your next study.