Helping you conduct post-approval studies on a global scale

Real World Evidence

Mapi is the industry’s only company exclusively dedicated to Patient-Centered Real-World research with over 40 continuous years of international operational experience. We provide strategic and operational expertise in the design and conduct of Post-Approval and commercialization programs for Pharmaceuticals, Biologics and Medical Devices.

Mapi is a full service provider with expertise in developing strategy and implementing programs supporting Pharmaceutical, Biotechnology and Medical device companies to:

post-approval regulatory requirements Meet post-approval regulatory requirements
Engage Patients, Prescribers and Advocacy Groups
Value for Payers and Endorsement Bodies Establish value for Payers and Endorsement bodies
Influence Key Opinion Leaders Communicate data to influence Key Opinion Leaders

Among the programs Mapi supports:

  • FDA/EMA-mandated studies (post-marketing requirement studies) to obtain pregnancy, pediatric, and other special population data, as well as additional safety, effectiveness, efficacy, and long-term exposure information
  • Global product/disease observational studies
  • Comparator trials conducted to compare competing products or compare a product vs. another treatment (CER)
  • Co-sponsorship of observational studies by biopharmaceutical companies that have products in a common therapeutic area or class
  • Increased industry collaboration by biopharmaceutical companies with regulatory agencies—such as the National Institutes of Health, CMS, and AHRQ—to conduct post-approval studies
  • Post-approval disease, product, and pregnancy registries to obtain evidence-based effectiveness, safety, and humanistic data from patients in a real-world clinical setting
  • Open label clinical trials to expand product indications (obtain additional safety or efficacy information, evaluate alternative dosing regimens, assess product interaction with co-morbidities or concomitant medications, etc.)
  • FDA/EMA/other International Regulatory Agency requested programs (EU-RMP, REMS) to minimise risks associated with use of pharmaceuticals, biologicals and medical devices post-approval

Request a consultation with an RWE expert