Apices’ medical monitoring team carries out medical monitoring reviews for clinical studies and reports their results to ensure the trials are conducted in line with the protocol, SOPs, ICH-GCP, and any applicable laws and regulations. We can prepare medical monitoring plans detailing medical monitoring responsibilities and requirements for trials, as well as for overseeing the integrity of data and the safety of the trial subjects.
Among the services offered by our medical monitoring team are:
- Medical support for preparing study documents
- Development of medical monitoring plans
- Medical data reviews
- SAE reviews
- Continuous medical oversight and medical monitoring of the trial
- Support with medical-related issues to ensure patient safety and protocol compliance
- Support for sites and study teams with questions related to selection criteria and other protocol-related queries
- Guidance for questions related to medical conditions
- Processing of flow and timelines throughout the conduct of the study
- Assistance with pharmacovigilance activities
- Reviews of study reports