OUR SERVICES
- Initiation of Studies
- Monitoring and SDV
- Drug Accountability
- Termination of Studies
- Feasibility process
- Site selection
- Prestudy evaluation visits
- Preparations of the study site prior to the conclusion of the contract
in order to achieve a prompt start of the study - Support regarding the internal site organization
(SOP‘s for sites, definition of responsibilities at the site, support regarding the contract design)
- Implementation of quality management systems and SOP‘s
(based on ICH GCP Guidelines, EU guidelines and national Drug Laws) - Preparation of audits and inspections
- Execution of audits (in-house and/or on-site)
- Coordination of the project and the personnel
- Communication with international study teams
- Preparation and transfer of necessary papers to Ethics Committees
- Preparation and transfer of necessary papers to supervising authorities
- Preparation and conclusion of contracts
- Selection of external services (central labs, central ECG etc. ...)
- Organization of Investigator Meetings
- Implementation of measures to expedite patient recruitment
Training of personnel in the field of:
- GCP
- Monitoring
- Patient recruitment,
- Project management
- study preparation
- study execution
- study termination
We also offer project specific training for clinical studies.
- Training on other topics in clinical research on inquiry
- Training for Study Sites (study coordinators, study nurses, investigators) in the field of:
- GCP
- patient recruitment
- organization of sites
In cooperation with our partner CDMS GmbH we are able to offer data management services
based on validated and user-friendly systems (electronic or paper based CRF)
- Data Management Plan
- Statistical Analysis Plan
- Creation of CRF
- Database Setup
- Data Entry
- Query process
- Data Transfer
- Statistical Analysis
- Tables & Listings
- Study Report
- Notifications of the Ethics Committees and state authorities
- Study support and monitoring
- Data management
- Analysis and reports