• 2,200+

    Drugs and devices with COA claims

Why use PROLABELS™?

Today, more than ever before, there is great interest in the wording and types of COAs contained within product labels approved by major health authorities.

  • Quickly identify competitive landscape

  • Find up-to-date information on COAs mentioned in label claims

  • Develop a successful patient-centric endpoint strategy in a drug approval process

 

What you will find in PROLABELS™?

A dedicated team at Mapi Research Trust continuously updates the PROLABELS™ database with information extracted from drug marketing authorizations available on the European Medicines Agency’s (EMA) website, and all New Drug and Biological Approvals on the US Food and Drug Administration’s (FDA) website. If at least one concept of interest is measured with a COA in the efficacy or safety sections of the labelling claim documents, the corresponding medical product is described in PROLABELS™.

New releases from EMA and FDA are implemented within a month. For all drugs and devices, different COA types (PRO, ClinRO, ObsRO, PerfO) have been considered.

 

For each product with a successful COA labeling claim:

  • Full detail and agency information on labeling claim
  • Study design and endpoints
  • COAs used and available information on them

Our user-friendly advanced search engine allows you to search by:

  • Therapeutic area / indication
  • Type of outcome assessments
  • COA concepts
  • Study endpoints
  • COAs (list of all COAs used in a successful labeling claim)
  • Marketing authorization holder
  • Source agency
  • Date of approval/date of claim

 

Learn more about PROLABELS™

 

One platform, three interconnected databases, the ultimate solution to select fit-for-purpose COAs.

By integrating three layers of information on COAs (COA description, label claims and regulatory guidelines) into one centralized platform ePROVIDE™, we aim at streamlining the COA selection process.

Find out more, visit our other databases webpages.