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Clinical Study & Site Management

Experience and Professionalism

With over twenty years of experience, we will help you meet study goals in the most efficient way possible. Continuous and ongoing site support allows us to achieve enhanced patient recruitment rates and deliver high-quality data. We understand the importance of your study data, as well as subject safety, recruitment and retention all the while remaining GCP-compliant and audit ready.

Some of the services we provide

  • Site Start-up
  • Study Plans and SOPs
  • New site training
  • Recruitment assistance
  • Source Document Creation
  • Regulatory Consulting
  • Budget and Contract Review
  • Blinded/Unblinded Pharmacy Roles

Site management support:

  • Continuous training: central laboratory procedures, IMP handling materials, equipment/software and documentation, patient’s visit schedule and procedures, support with expenses and site invoicing.
  • Patient Recruitment: site-specific patient enrolment plans/goals, feasibility of patient referral programs, relationships with patient advocacy groups/communities, implementation of agreed patient engagement procedures, and local/central advertising.
  • Patient Retention: activities to reduce patient burden, fear and uncertainty, identification of patients at risk of drop out and plans to keep them in the study, and patient concierge services to ease the burden for patients.
  • Logistical and administrative: preparation for first patient visit, tracking and storage of supplies, processing and shipment of samples, assessing/ensuring site compliance in visits scheduling, assessing patient compliance with visit attendance /treatment compliance.