CLINICAL TRIALS

THE MELODY IN CLINICAL TRIALS

CLINICAL OPERATIONS

Opera performs Clinical Trials from Phase I to IV in a wide range of countries: East and West Europe, South America and Asia (Middle and the Far East), depending on a Sponsor’s necessities.

Clinical trials related services include all necessary activities starting from Trial Design, Protocol writing, sites selection, ethic-administrative Submissions, Monitoring and Data Management up to Statistical Analysis and Medical Writing.

The aim of this study is to systematically review recent literature on oral plant extracts acting on sleep disorders distinguishing their action on the different symptoms of sleep complaints.

Plant Extracts for Sleep Disturbances: A Systematic Review.

Clinical Trial Preparation

Opera provides support for study design and protocol development in the early preparation stages of a clinical trial program, as well as for CRF design and computerized databases in order to ensure the optimization of the data collection and organization process.

Clinical Monitoring

The highest quality review of data and effective interaction with study sites are the top priorities of our clinical operation team during on-site monitoring visits.

Investigator & Site Selection

Good selection, management and assistance are vital to a study’s outcome. Opera provides can provide experienced investigators and gives recommendations based upon past experience with reputable institutions suitable to your study requirements.

Clinical Trials Management

Our experienced Clinical Project Managers are responsive and proactive, and ensure that the right resources are used with established procedures to maximize efficiency throughout your study.

Reporting & Medical Writing

Opera provides full services to ensure the clinical protocol approval by Ethical Committees and Regulatory Authorities. Our start up and legal offices manage specific regulatory submissions in compliance with national and international requirements to assure a higher probability of success.

Data Management & Statistics

To ensure generation of high-quality, reliable, and ready to be statistically analyzed data, our data management unit is involved from the beginning to the completion of a clinical trial.