Clinical Research Director
Project Leaders
Scientific Advisors
IT/IS Director
Data Manager
Independent Experts
At the beginning of each study, our team of cross-functional experts can advise you on the necessity of adding a CEC or Core Lab Committee to your study and integrating it into the protocol. According to best practices and company SOPs, our staff can develop the necessary manuals and develop a module to our data management platform, EDClinTM, for the handling of adjudication and safety data in real time.
This means you can collaborate with independent experts from around the world and have a seamlessly integrated data management solution combining the trial data and the experts’ opinions.
We can prepare and chair the meetings - on site or remotely, prepare patient summaries, and produce reports according to Sponsor needs and preferences.
This integrated department handles the strategic planning, data crunching, and medical communications projects. Our methodology experts combine their know-how on statistical methodology and their expertise in scientific communications to deliver protocols and SAPs, write study documents, study reports and publications, and produce statistical reports and custom data analyses.
The main function of this department: conceiving and managing the best strategy for your clinical evaluation.
Writing of Core Lab & CEC manuals
Expert training
Core Lab & CEC meeting organization
Core Lab & CEC EDC module development
Patient summaries preparation
Adjudication of safety events in EDClinTM
EMA's Guideline on Data Monitoring Committees
WHO's Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards
FDA's Establishment and Operation of Clinical Trial Data Monitoring Committees- Guidance for Clinical Trial Sponsors
FDA's Clinical Trial Imaging Endpoint Process Standards Guidance for Industry
Committee charters
Operational management of independent expert committees
Data management