Unique logistical challenges and lack of precedence can make rare disease trials intimidating. Worldwide offers customized insight, deep expertise and novel solutions to get the most out of your efforts.
The standard approaches used in large-scale studies often don’t apply to the world of rare disease research, so intelligent innovation and careful consideration can help maximize the impact of all data, even from a small number of patients. You need a team that combines deep scientific expertise with fresh perspectives on design and patient outreach—experts with decades of experience in the basics and the willingness to innovate to find a unique approach that will work for your program.
Joanna has more than 30 years’ experience in directing global projects in many therapeutic areas across all phases of clinical trials. As a key member of Worldwide’s leadership team, her personal aim is to motivate and empower project teams to achieve project goals and surpass customer expectations. Her career has focused on managing portfolios of work in the endocrinology and inflammatory therapeutic areas, and she has significant experience in autoimmune diseases, rare disease indications, biosimilars, and rheumatology.
Derek has worked in clinical research for more than ten years with a focus almost exclusively in rare and pediatric diseases, including non-malignant hematology, autoimmune diseases, metabolic disorders, movement disorders, and other genetic conditions. At Worldwide, he leads and supports corporate initiatives within rare and pediatric diseases and maintains relationships with over 45 patient-focused advocacy organizations. Derek holds a master’s degree in Pharmacology and Toxicology from Michigan State University and is pursuing a master’s degree in Genetic Counseling from Bay Path University.
Ian’s career in clinical research spans three decades and includes experience in both CROs and pharmaceutical companies. At Worldwide, he works to improve the lives of patients by shepherding novel treatments from the lab to the marketplace. Ian oversees strategic development, project management, and operational delivery across immunology/inflammatory diseases (including rheumatoid arthritis, lupus, psoriasis, IBD, asthma, COPD, and more), rare diseases (such as sickle cell disease, IPF, bullous pemphigoid, cutaneous T-cell lymphoma), and oncology.
This paper will examine the approach to feasibility in rare, geographically dispersed populations with particular attention to the perspectives of those stakeholders responsible for facilitating trial design and operations.Learn More
Read how we helped our sponsor navigate a challenging protocol and unexpected challenges while still delivering the study on time.Learn More
Our unique approach to GBM draws on a holistic and comprehensive set of services, empowering sponsors to make informed decisions faster.Learn More
Our expertise in biomarker development and custom-validated clinical assessments takes the guess work out of selecting the proper endpoints for your clinical trial.
Finding patients remains a critical piece in rare disease research. We have decades of experience working with patients, families, advocacy groups, and key opinion leaders in rare conditions to help recruit and retain our most vulnerable patient populations.
Worldwide collaborates early and often with regulatory agencies to improve the selection of outcomes measures and the appropriateness of endpoints. Our nimble global network helps ease the way toward submission—without last-minute surprises—for approval by regulatory agencies around the world.
Rare disease trials are increasingly more complex. Worldwide navigates these immense logistical challenges using smart operations planning, our vetted global network, and our experienced team to ensure that even the most complex rare disease trials run smoothly toward a new drug application.
Rare and orphan disease clinical research presents a unique set of obstacles. That’s why your drug development program deserves a partner with the right tools to help you navigate the journey.
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