Services

Regulatory


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Assistance to our clients with regulatory submissions for clinical trials

OPIS team assists our clients with regulatory submissions for clinical trials in compliance with local and international regulations and guidelines. Our staff is prepared to provide support in the preparation of the submission package, as well as in the management of electronic submissions according to applicable requirements.

Our expertise include support for EU VHP submissions and management of ClinicalTrial.gov and EudraCT.

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 Patform - OPIS CLINICAL.NET