Resources and expertise that help solve the unique challenges of rare disease research

Patient Centered Outcomes

The paradigm within the healthcare industry is changing, and market authorization is no longer the endgame. Today, the key is focusing on market access and anticipating market adoption by both prescribers and patients. To ensure success, a strategy that has been developed from the earliest point in your clinical trial lifecycle is of the utmost importance.

With that in mind, Mapi takes a phased approach to Patient-Centered Outcomes research. Over 20 full-time professionals devote themselves to taking on the challenge throughout the lifecycle of the drug and the disease (PhI – Post Market).

Patient-centered services for the entire development process

  • Mapi provides insight from the beginning of strategy development all the way to execution
  • We keep all stakeholders involved and engaged: industry payers, regulatory authorities, payers, investigators, academic researchers, and patients
  • Our services cover a product’s full lifecycle, from early development to real world evidence
  • Mapi provides conceptual, linguistic, and metric equivalence for cross-cultural projects
  • Our experts develop cross-cultural scales in multiple languages simultaneously

Mapi’s Patient-Centered Outcomes Services Help Your Team Focus on Who Matters Most: The Patients

Strategic Consulting: Mapi’s experts are on-hand to help you navigate the options you need to
consider when embarking upon discussions concerning COAs.

COA Endpoint Strategy: Mapi sees your drug lifecycle in its entirety. We develop endpoint strategy that will support you all the way through regulatory submission to prescriber buy-in.

COA Development: With over 80 scales developed by our experts, we have a wealth of knowledge on optimizing development, managing cross-cultural issues, and successfully creating a meaningful COA for patients.

Psychometric Validation: Our experts have psychometrically validated over 100 COAs and we are well-versed in modifying and validating COAs in new populations to adopt them for your specific therapeutic indication and population.

Preference Studies: Discrete Choice Experiment (DCE) studies help you to explore respondent trade offs by using a rigorous methodology that will help build your communication to HCPs, payers, and regulators.

Mixed Methods Research: Our approach combines both qualitative & quantitative methods. For example, we incorporate qualitative exit interviews into clinical trials while also utilizing statistical techniques to reinforce the findings of your qualitative research.

Statistical Analysis of COA Results: Our team of biostatisticians specialize in quantitative data analysis and will support your statistics teams in interpreting COA results and help build a meaningful story and communication.

Adherence & Acceptance: Mapi has developed specific expertise in the development and validation of adherence measures for real life studies and routine clinical care.

Screening Tools: Over the past decade, Mapi has refined the development of screeners to guarantee adoption by HCPs in their everyday clinical practice by evaluating the patient’s opinion through a solid tool that is accepted both by patients and HCPs.

Expertise in Rare Diseases