Your pediatric development milestones are unique, just like the specialized population who rely on your drug to be successful
You are discovering and developing novel pediatric treatments to advance care for the unique needs of infants, children and adolescents. IQVIA understands the need to design trials specifically for pediatric patients. You need a specialized mix of therapeutic, regulatory, and operational strategies to ensure your pediatric studies are successfully planned and executed – with patient safety at the center of everything you do.
Unrivalled institutional knowledge you can rely on. Through both our Pediatrics and Rare Disease Centers of Excellence, we provide counsel on planning and design, reduce protocol amendments, offer Regulatory insights, and suggest unique recruitment models to maximize your opportunities, and with confidence. We customize plans to ensure pediatric trials progress successfully in parallel with adult programs.
- Establish a predictable path forward. The IQVIA CORE™ empowers you to precisely select the best sites for faster enrollment of the right patients. We provide a variety of plans that foresee pediatric trial obstacles. You gain a reality-based and predictable study plan that increases your chances for success. In this highly diversified arena we recognize that your drug and your development process are unique. We’ve provided clinical services for more than 500 pediatric studies involving more than 190,000 patients across 110 countries since 2010.
- Regulatory expertise can determine your success. You require a team that understands the inherent challenges of working with regulatory, and who can help you reap the benefits of exclusivity incentives. The FDA and EMA require evidence of pediatric safety and efficacy, placing additional pressures on drug development programs and requiring a partner skilled at addressing these regulatory obligations. By understanding regulatory expectations and planning ahead to meet them, you can be more certain that your drugs will be delivered to children in need as quickly and safely as possible.
- The right partnerships maximize your potential. We have established relationships with patient advocacy groups, and prime and partner sites that are expert in the special needs of pediatric studies. We recognize the similar operational challenges of Rare Disease and pediatric studies and work across our respective Centers of Excellence to facilitate your success.
Let us help you develop and deliver your pediatric treatment successfully.
By: Claude Hughes
By: Kathy Beach