Biomapas Medical Monitoring team consists of highly experienced licensed medics who have gathered a significant amount of experience in various therapeutic areas throughout the years in Phase I-IV studies.
According to Sponsor needs, Biomapas Medical Monitors are able to provide the following services:
- Primary Medical Monitors and secondary therapeutic field Medical Experts support;
- Assistance for PM in development therapeutic area, investigational product and protocol training;
- Assistance for PM in identifying the key risks to data critical to the primary objective and provision of medical input into risk mitigation strategies;
- Medical Monitoring Plan development;
- 24/7 coverage medical monitoring;
- Medical Monitor oversight and support to study team, investigators and sites;
- Assurance of safety and quality by assisting in protocol interpretation, laboratory and ECG surveillance;
- Medical input into adverse event handling, including review of cumulative SAE listings and any other emergent safety information;
- Review of the clinical data and critical parameters of the study;
- Provision of input in corrective actions plans;
- Medical coding of AEs and medications;
- Investigator/site education (Preparation of training material for Investigators, attendance at Investigators Meeting);
- Provision of medical input in regulatory submissions, if required.