Management and monitoring of clinical trials

The CRO AX CT Project Monitoring Services team oversees, controls and ensures that the clinical trial is conducted, documented and communicated to the appropriate authorities in accordance with the Study Protocol, GCP rules, standard operating procedures and official requirements. As part of monitoring, our specialists perform the following functions:

• Conducting monitoring visits: selection visit, clinical center initiation visit, routine and remote visits, closing visits of clinical centers
• Ensuring that all required notices/approvals from local ethics committees of organizations are in place
• Verification of receipt, storage and distribution of the investigational product, biomedical cell product and reference product
• Accounting for stocks of research materials
• Study enrollment control
• Confirmation of procedures for obtaining informed consents from subjects
• Monitoring compliance with the protection of the rights and interests of research subjects
• Control of the correctness of the randomization procedure
• Control of proper storage and maintenance of study documents
• Monitoring the registration of adverse events
• Tracking and timely reporting of SAEs and pregnancy, as well as deviations from the protocol
• Monitor compliance with applicable regulatory and protocol requirements
• Checking the correctness of maintaining primary documentation
• Checking the transfer of data to individual registration cards
• Control of preparation of documents for archiving
• Preparing visit reports