Our rare disease research teams are focused on the design and execution of rare disease drug development. We are recognized as leading experts in assisting biotech and pharma companies in the rare disease niche. Through our Site Management model, Study Physician team, and Patient Engagement support, we find hard-to-locate patients around the globe, and work with physicians to create the study designs and operational strategies to support complex clinical programs.

Ergomed’s Patient Engagement Officer

Bojana Mirosavljevic is an internationally awarded rare disease expert, fund-raiser, and lobbyist. Winner of European Black Pearl Award for Written Media 2018 (EURODIS European Organization for Rare Diseases, Brussels).

Solutions-driven and patient-centric service:

• Provides input into all relevant study documents, including protocols
• Reviews all patient-facing material
• Provides a rare disease perspective to the project team
• Close collaboration with Patient Advocacy Groups
• Ability to leverage extensive patient advocacy network

Patient Organization Representative Board

Ergomed launched a Patient Organization Advisory Board based on the growing recognition – both within the biopharmaceutical industry and regulatory agencies – that patients need a greater voice in the development of new medicines. Rare disease patients are often experts in their conditions, and patient groups can be a driving force in pharmaceutical R&D. Members of the advisory board strengthen our patient-centric approach in clinical research. They offer patients and their representatives more opportunities to provide patient input into the clinical-stage drug development planning. The advisory board consists of up to seven experts from patient organizations, representing a wide range of therapeutic areas. It will play a key role in driving successful rare disease drug programs for our clients.

Our continued efforts to leverage the valuable knowledge available within patient organizations in the preparation and execution of rare disease clinical trials will contribute significantly to Ergomed’s goal of assisting our clients in delivering new therapies for rare diseases.

Ergomed Orphan Toolkit

Since rare disease patients are scarce and scattered, it’s essential to offer tools that help decrease the patient and family burden. Ergomed offer a wide array of Patient Concierge Services to increase recruitment and retention and ensure a successful trial:

• Family reimbursement services
• Interaction with patient groups
• Cross border referrals
• Homecare
• Patient and family travel
• Interpreter

Rare Disease Drug Development

Rare disease drug development is Ergomed’s core strength, and we are committed to helping those in need. Our expert team allows our clients to implement patient driven solutions in clinical trials. We believe that patients will define our future landscape, including the rise of both precision and preventative medicine.

The key factors that set Ergomed’s expertise apart are as follows:

  • Unique insights into rare disease and orphan drug development programs, solving specific challenges and needs that rare disease trials require to address challenges of safety and efficacy

  • Global access to hard-to-find patients in under-served regions

  • A regulatory consultancy service for complete support of orphan drug-related interactions with the EMA and FDA (e.g., Orphan Drug designations, PIP, Protocol Assistance/Scientific Advice)

  • A unique site management model that allows for faster recruitment of quality patients and site coordination

  • Patient Concierge Services, reducing study burden on patients and their families

  • Engagement with Patient Advocacy groups and support organizations, raising disease and study awareness, contributing to enhanced enrolment and retention

  • Ergomed’s Patient Organization Advisory Board representing the patient’s voice to enhance study design and execution

Ergomed is proud to have a strong heritage in assisting biotech and pharma companies with rare disease drug development and offers a full range of high-quality clinical research and trial management services.

View our Case Studies here:

Cross-border Enrollment

Alkaptonuria

Wilsons Disease