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:

  • Meet post-approval regulatory requirements
  • Engage Patients, Prescribers and Advocacy Groups
  • Establish value for Payers and Endorsement bodies
  • 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

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