Engaging directly with patients throughout the entire product lifecycle

Patient-Centered Sciences

Mapi’s Patient-Centered Sciences comprises expertise spanning four decades of innovation and research on directly engaging with patients across the entire healthcare landscape and through the entire treatment lifecycle.

Patient-Centered Outcomes
Mapi is the world-leader in Patient-Centered Outcomes Research. For more than 20 years, Mapi has provided a full service approach including the development, validation, licensing, translation, cultural validation and analysis of Patient Reported Outcomes (PRO). We help medical product companies (pharmaceutical, medical device, biotechnology) at every stage of the development process moving from endpoint selection through PRO development, use in clinical trials, post-approval work and publications. We help our clients negotiate with international drug regulatory agencies and health care payers regarding the appropriate use of patient reported information in clinical trials, drug approval and drug reimbursement. We have experience in over 200 different therapeutic areas, work in over 165 different languages and have the world's largest database of PRO and other clinical outcomes assessments (COA).

Patient Insights & Engagement
Mapi is a world leader in providing an understanding of the patient and the many factors that influence their health behavior and decision-making process to improve clinical trial design, clinical operations and patient engagement activities. Our collaboration with patients, caregivers and patient advocates means we can help our clients better inform and engage with their distinct populations throughout the world. We bring the patient’s voice into all aspects and phases of the product development and commericialization process.

Patient Logistics
Mapi has been working for over the past 15 years in more than 40 countries to help clinical research teams improve the patient experience by providing services to increase patient compliance, improve patient satisfaction and increase patient retention. These activities are directly focused on improvements which help to reduce the need for over-enrollment and decrease the costs of loss to patient follow-up. This is especially important to our clients in clinical development because of the focus on smaller disease populations where there is more competition for patients. As a result, each patient enrolled is substantially more important and sponsors can substantially increase the chance of clinical study success and reduce their time to drug approval by using our patient-focused services.

Advice on Regulatory Environment and Patient Input
Patient reported information and patient engagement are becoming a larger part of drug and medical device approval process at international regulatory agencies. We help our clients understand this environment and build strategies and activities to meet the expectations of this evolving environment.

FDA — Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims

FDA — Patient Participation in Medical Product Discussions

FDA — Medical Devices (CDRH) - Advisory Committee on Patient Engagement

EMA — Patient and Consumer Involvement in Drug Approval Process

These combined services establish Mapi as the clear industry leader in supporting patients or their caregivers, and offer proven results for accelerated drug development, improved recruitment, increased patient engagement, excellence in patient-reported data, and minimized study burden and attrition.

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