Bringing solutions to complex clinical development

Rare Diseases, Advanced Therapies and Pediatrics Team (RAPT)

Your specialized team for complex and novel clinical trials.

The areas of rare diseases, advanced therapies and pediatrics are integrally linked. Of the over 7,000 rare diseases, approximately 80% manifest in pediatric populations and the majority are monogenetic diseases—ideal targets for cell, gene and other advanced therapy modalities.

As drug development is growing exponentially in these areas, our Rare Diseases, Advanced Therapies and Pediatrics Team (RAPT) provides the cross-functional and specialized expertise necessary to advance these complex and novel trials.

Rare Diseases

Cell and Gene Therapies

Pediatrics

Experience matters when choosing a partner.

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In the last 5 years

We’ve been honored to serve as a CRO partner of choice for our biotech and pharmaceutical customers as we’ve advanced their development. We are also known for our thoughtful approach to novel/unknown areas with no development precedence. In the last five years, we’ve supported the following:

877

Rare Disease Studies

156

Advanced Therapies (Cell, Gene, RNA+)

380

Pediatric Projects

Top Therapeutic Areas

Oncology and Hematology | Neuroscience and Ophthalmology | Endocrinology and Metabolism | Cardiovascular and Pulmonary

Get flexible solutions with an integrated approach.

Our team aspires to deliver with quality and exceed our clients' expectations. We problem-solve, innovate and provide the flexibility required to meet the unique needs of rare disease and pediatric patients. We ensure that lessons learned in one area or study are disseminated across the organization and support projects through a highly collaborative approach to build exceptional partnerships with our clients.

Clinical development and consulting services
With early engagement of our sponsors, we can support:

Clinical Development Plans

Protocol design and ICF development

Regulatory agency meetings

Country and site selection strategy

Delivery strategy
Enabling a patient- and family-centric approach
Get proven solutions and services that reduce the study burden while improving your study’s visibility and credibility:

Voice of Patient/Parent insights

Considerations for “Enrolling the Family”

Patient advocacy group partnerships

Patient-friendly materials and study tools

Patient concierge travel and reimbursement

Support retention with risk identification and mitigation
Training and investigational site support
Training and support help complement your messaging and minimize the burden for your sites and partners. We offer:

Study-specific disease/therapeutic/product training for study teams

Specialized vendor training

Comprehensive operational training

Patient journey mapping

Customized patient recruitment and retention

Site education materials and site-specific patient support
Communication and governance oversight
From from pre-award through study close out, we aspire to develop a culture of transparent collaboration with your team by delivering:

Real-time support of study teams

RAPT project/metric reviews

Contingency plan development

Ongoing risk mitigation
Driving more efficient delivery of your studies
Working as an extension of your team, we offer timely troubleshooting for the unexpected and will share our best practices for:

Minimizing blood draw volumes

Enabling the early inclusion of adolescents

Implementing and executing your endpoint strategy

Identifying and preventing risk

Coordinating collaboration across our clinical development services.

Our RAPT members are senior, seasoned professionals, who work seamlessly with Fortrea therapeutic area-specific study teams and related groups, spanning Regulatory Strategy Consulting, Patient Recruitment and Engagement, Trial Strategy and Planning, Clinical Pharmacology, Decentralized Clinical Trials, Mobile Clinical Services and Market Access.

Our approach is both formal and flexible, allowing for real-time support, including:

Quarterly Fortrea community calls and newsletters to share successes and learnings
Targeted team training, as well as participation in our company “WISER” events to share lessons learned
Regular office hours and internal governance review meetings of our RAPT project portfolio

Get to know us

“For more than two decades, I have sought to make a difference for patients by developing new medicines and bringing hope and the promise of a better life to those who are suffering. Rare diseases have been particular interest due to the unique hurdles patients face and the challenges presented when developing medicines for small populations. I am grateful Fortrea has afforded me the opportunity to address these challenges and advance the state of the art in diseases with such significant unmet medical need.”

– Frederick Derosier, DO, Vice President, RAPT

Frederick Derosier, DO Vice President

Louise Kearney, MSc, PMP Executive Director

Leone Atkinson, MD, PhD Executive Medical Director

Meet the team

Your needs. Our solutions.

As a provider of comprehensive Phase I through IV clinical trial management, clinical pharmacology, patient access solutions and other enabling services, Fortrea partners with emerging and large biopharma and medical device and diagnostic companies to drive healthcare innovation throughout the world.