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
Core Lab & CEC meeting organization
Core Lab & CEC EDC module development
Patient summaries preparation
Adjudication of safety events in EDClinTM