CRO
Contract Research Organization
The experience of the CEDEMICA work team, in the area of the development of new medicines and medical devices, makes new therapeutic options available to patients who need them more quickly and efficiently, either through a clinical research study or through the availability of the registered product for commercialization.
CEDEMICA responds to the needs of the Clinical Research ecosystem and has created the CRO Services Business Unit.
Our team of Experts in Medical Innovation, Regulatory Affairs, and Biostatistics provide an excellent service, focused on the client's needs and the expected results.
Clinical Study Site Management & Monitoring
• Site recruitment.
• Study initiation visits.
• Site qualification.
• Interim study monitoring visits.
• Site budget development.
• Maintenance of essential regulatory documents.
• Site contract negotiations.
• SAE/UADE initial contact & follow-up.
• IRB/Ethics Committee submission coordination.
• Site/subject payment administration.
• Site training program development
• Study product inventory management.
• Investigator meeting.
• Study close-out visits.
• Study participation recruitment program development.
Clinical Study Data Management/Biostatistics
• CRF development.
• AE coding.
• Database development.
• Data QC, entry & verification development.
• Subject randomization plan.
• Query generation & resolution.
• Statistical analysis.
Medical Writing
• Protocol development.
• Clinical study report(s) development.
• Clinical Investigator Brochure development.
GCP Compliance
• Study audit.
• GCP training.
• SOP development.
• Assistance with FDA site inspection.
Regulatory Affairs
• Coordinate IDE/IND application and Medical device application.
• Establishment registration.
• Assistance with Regulatory Authority site inspection.
• Coordinate NDA application in Mexico.
