Study Start-up and Feasibility
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Study Start-up and Feasibility
We accelerate the path from study identification to first-patient-in by managing all critical activation tasks. Our proactive approach ensures your site is set up for success from day one.
Site Feasibility Assessment
In-depth evaluation of your site’s capabilities, patient demographics, and infrastructure to match you with the right trials.
Protocol Review and Analysis
Comprehensive analysis of study protocols to ensure operational viability and identify potential challenges early.
Budget Development and Negotiation
Meticulous creation of detailed study budgets and expert negotiation with sponsors/CROs to secure fair and adequate funding.
Clinical Trial Agreement (CTA) Negotiation
Scrutinizing and negotiating legal agreements to protect your site’s interests regarding liability, intellectual property, and payment terms.
Regulatory Submissions and IRB/EC Management
Preparation and submission of all necessary documentation to Institutional Review Boards (IRBs) and Ethics Committees (ECs) for initial approvals and ongoing amendments.