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Medical Monitoring

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.

All Clinical Trial PV Services

Safety Throughout Clinical Development.