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Independent committees
At the beginning of each study, our team of cross-functional experts can advise you whether to include a CEC or Core Lab Committee and integrate it into the protocol. In line with best practices and company SOPs, our staff can develop the necessary manuals and corresponding safety module, which will be included in our data management platform, EDClinTM for the adjudication of safety data in real time. This means you can collaborate with independent experts from around the world. By combining trial data and expert opinions, ClinSearch offers a seamlessly-integrated data management solution.
We can prepare and chair the meetings – on site or remotely, prepare patient summaries, and produce reports tailored to Sponsor needs and preferences. This integrated department handles 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, study documents, study reports and publications, statistical reports and custom data analyses.
The main function of this department is to conceive and manage the best strategy for your clinical evaluation.
Our solutions
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
Resources
Clinical research director
Project leaders
Scientific advisors
IT/IS director
Data manager
Independent experts
Activities
Committee charters
Management of independent expert committees
Data management
Standards
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