Medical Monitoring
Our medical monitoring expertise across various therapeutic areas ensures that studies are conducted
appropriately and in compliance to regulatory requirements and ICH GCP guidelines. Medical support throughout
the study supports the sites to conduct the study without any doubt and confusion, and data review ensures
the quality and integrity of the clinical data.
We provide end-to end monitoring services – reviewing the protocol, informed consent documents, planning documents
and other pertinent study documents, and hospital medical records; issue queries; checking master files;
attending study teleconferences; assisting in the preparation of regulatory submission dossier, site evaluation
and selection, clinical sites with IRB submission, and in the planning of investigator meetings; data cleaning, etc.
Different skills are required for different tasks, so the monitor has to play different roles.
We assure you to provide the best monitoring services and help in the successful conduct of your study.