The paradigm within the healthcare industry is changing, and Market Authorization is no longer the end-game. Today, focus on Market Access and anticipating Market Adoption by both prescribers and patients is key. To ensure success, a strategy 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 100 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
- Full Insight: from Strategy to Execution
- All Stakeholders: Industry Payers, Regulatory Authorities, Payers, Investigators, Academic Researchers, and Patients
- Full lifecycle: Early Development to Real World Evidence
- Cross-Cultural: Conceptual, Linguistic, Metric Equivalence
- Fully capable in simultaneously developing multi-language cross-cultural scales
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.
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.
ePRO, eCOA, and eDiary development
Mapi creates electronic tools for assessing patient reported outcomes that are 'born digital.' We combine our scientific expertise and our extensive partnerships with EDC providers and smartphone application developers to bring our clients innovative new tools that combine the best of traditional methods with new tools that expand the assessment of patient outcomes.
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.
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.
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.