ChemDiv chemistry of cures

We provide medical oversight of all studies by the review/monitoring of adverse events and laboratory values and will submit all SAEs to the Russian regulatory authorities on behalf of our clients. Our Medical Monitor works closely with the sponsor and each project group throughout the course of a study. ChemDiv's Medical Monitoring services connect all phases of clinical research. To ensure quality performance of clinical activities, ChemDiv's Medical Monitor provides:

• Feasibility Assessment
• Medical Monitoring and Liaison
• Safety Management and Surveillance
• Literature Evaluation (Competitor Analysis)
• Medical Consultation
• Therapeutic Area Training and Guidance
• Project Team Therapeutic Leadership
• Interface with Data Safety Monitoring Boards (DSMB)
• SAE Reporting Assessment
• Regulatory Evaluation of SAEs
• Quality medical and safety coverage 24 hours a day, seven days a week, 365 days a year

Qualified and experienced in the clinical development process, our Medical Monitor collaborates closely with our Regulatory Manager, Investigators and the Clinical Project Team.

One of the most important functions of our Medical Monitor is safety surveillance and serious adverse event (SAE) management. We take this responsibility seriously and give special attention, oversight throughout the course of each study to ensure that patient safety is paramount, and patient risks are minimized. Our Medical Monitor will ensure the adverse events are properly identified and thoroughly investigated, reported and tracked in accordance with ICH GCP, Sponsor and Local Regulatory requirements.

Find attached:

ChemDiv-Clinical_Development.pdf