Services

Trial Start-Up


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Premium support and expertise in submission, follow-up and authorization procedures

From early development to Phase IV, non-interventional trials, investigator-initiated trials, clinical investigations with medical devices and projects on nutraceuticals and food for special medical purposes, OPIS expertise is at our clients’ service at this important stage of clinical trial management. 

Start-up activities include:

  • Electronic Investigators Network in diverse therapeutic areas
  • Feasibility. Our experienced staff perform feasibility activities to assess site suitability and conformity
  • Site selection
  • Submissions to IEC/IRB and follow-up
  • Negotiations of contracts and budgets

Regulatory
Trial Start-Up
Study Management and Monitoring
Data Management
SAS Programming
Statistical Analysis and Consultancy
Pharmacovigilance
Quality Assurance
Medical Affairs and Medical Writing
Preclinical and Drug Development Consultancy
Project Control
e-Clinical Platform - OPIS CLINICAL.NET