Accelsiors is a full-service Contract Research Organization (CRO), providing expert services in all key areas of the drug development process; however the Clinical Development is our main and the most robust business activity. For each clinical trial, Accelsiors allocates a dedicated and well trained Project Team. The project team is leaded by experienced project manager or project director supported by managers of different Accelsiors business units, like Logistics and study setup, Record Management, Regulatory, Pharmacovigilance and Medical Monitoring, Quality Assurance and other units, depending on the scope of contracted Accelsiros services.
We do have a very flexible and open approach to projects,hence the overall management is combined with Accelsiors ability to act in the multicultural environment and to provide locally based responsive service to clients, as having international personnel located in countries with Accelsiors operational presence.
Clinical Operations Unit holds responsibility for the conduct of the trial from identifying and selecting investigators to the completion of tasks for the clinical study closure according to the ICH GCP, applicable regulations and clinical trial protocol.
Clinical Operations executes procedures such us:
- Study Protocol development
- Clinical study management
- Developing list of potential investigators according to selection criteria for the project
- Assessment of investigator’s suitability
- Coordination and general logistics of investigator meetings
- Investigators training
- Ensuring the initiation and conduct of the clinical trial according to applicable regulations and requirements
- Regular trial monitoring
- On site IMP accountability and management
- Regular communication and sites management
- Preparation, review and translation of clinical trial documents
- Handling of essential documents
- Control and tracking of study supplies
- Site closure activities
With our extensive experience and well placed resources, we boost your study progress at its every stage from the planning through management up to the reporting of results. Reducing time to market is one of the key objectives in modern drug development. Via flexible strategies and through quality relationships with important centers and opinion leaders, Accelsiors is the ideal partner to achieve this goal. Our support ensures rapid progress and shortened time to market.
