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. 

Explore our areas of expertise

Experience matters when choosing a partner.

Let's Connect

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

Fique por dentro:
Inscreva-se para receber notícias e anúncios da Fortrea.

Inscreva-se já