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We offer site-level operational consulting services designed to improve protocol feasibility, workflow clarity, and trial execution. Services are provided à la carte and tailored to each sponsor’s specific study needs.
Comprehensive site-level review of clinical trial protocols to identify operational risks, unclear language, and execution challenges before study launch. Reviews focus on real-world site workflows, staffing impact, and patient feasibility.
Each study has its own unique participant facing documents. Whether this is the drug diary, questionnaires, or app, our team can perform a thorough review to ensure feasibility and workability at the site level.
Assessment of day-to-day study workflows from the coordinator and site staff perspective, identifying unnecessary complexity, inefficiencies, and administrative burden that can impact enrollment, retention, and data quality.
Review of eCRF design and EDC workflows from a site user standpoint to identify areas of confusion, redundancy, or misalignment with protocol requirements. This is a review service only and does not include system build or configuration.
Targeted review of planned or proposed protocol amendments to assess downstream site impact, retraining needs, and operational risk prior to implementation.
Structured scoring of protocols and operational elements to provide sponsors with clear, actionable insights into execution risk, complexity, and site burden, supported by written recommendations.
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