Services

Study Management and Monitoring


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Experienced project managers and CRAs to execute your trials across Europe

OPIS 20-year experience in clinical trial management and monitoring, and our proficient and well-trained Clinical Operations staff ensure the highest quality standards of the services offered.

Our Project Managers have great professional skills and can manage complex clinical studies. They act as a primary liaison for the Sponsor ensuring streamlined communication among all the parties involved in the study. Responsibilities and reporting lines are clearly defined at an early stage. Our Project Managers ensure project execution in compliance with the contract and all applicable requirements maintaining the highest quality standards and ensuring that timelines are met. Moreover, our Project Managers are responsible for overseeing the monitoring activities and the trial progress, including 100% review of monitoring visit reports and periodical documentation check.

We have an extensive network of experienced CRAs to cover 30 countries.

All the CRAs are fluent in English and have excellent knowledge of the ICH GCP R2, of the local environment and its medical practices. Monitoring model comprises on-Site Monitoring visit and Remote Data Review. The combination of remote and on-site visits is proposed during contract negotiation to oversee the study progress in the sites involved. The use of the risk-based adaptive approach in the monitoring of clinical trials, as well as a mandatory requirement, is the only way to favor the implementation of more efficient systems for the conduction and supervision of clinical trials.

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