Specialized Expertise to Overcome Unique Challenges of Pediatric Clinical Research
Pediatric clinical research presents a unique set of considerations, including recruiting, inclusion/exclusion criteria, subject compliance, and retention. Clinical development in a pediatric population demands a pediatric CRO with both medical and regulatory expertise as well as experience working with this vulnerable and special patient population.
Navigate the many complexities of pediatric clinical trials with a team of highly qualified and experienced medical, regulatory, and operational experts who understand the unique concerns raised by ethics committees, investigators, and parents. As a full-service clinical research organization (CRO), Medpace can help develop strategies to address specialized needs and drive the successful conduct of a pediatric study.
Making the Complex Seamless® in Global Pediatric Clinical Trials
Medpace has built an experience base in the management of pediatric clinical trials throughout our 30 year history. Sponsors from emerging biotechs to global pharmaceutical companies trust Medpace to lead their pediatric clinical development across a wide range of therapeutic areas, including infectious diseases, type 2 diabetes, familial hypercholesterolemia, and neuroblastoma.
Our medical, operational, and regulatory specialists have relationships with investigators, deliver faster enrollment timelines, and obtain access to country-specific pediatric patient populations.
Pediatric CRO Capabilities
Proactively plan and execute trials of all sizes by partnering with the Medpace Pediatric Team to conduct your clinical trials. Gain a competitive advantage through our global expertise and experience while benefiting from:
- Global operations support pediatric recruitment and execution of studies around the world while maintaining ethical considerations at both local and global levels
- Improved efficiency through experience in rare diseases and orphan indications which often involve pediatric populations
- Increased efficiency for addressing the testing components of pediatric trials through global laboratory services including fully-integrated central laboratory, bioanalytical lab, and imaging and ECG core labs
The Complexities of Pediatric Rare Disease Clinical Trials
Regulatory and Operational Strategies for Success
Patient Recruitment & Retention
Trials involving children and adolescents are particularly challenging for recruitment and retention. The enrollment of subjects in a pediatric clinical trial has the complexity of family dynamics, legal status, and requirements of informed consent and assent. Our dedicated patient recruitment and retention team works hand-in-hand with the project team and employs creative strategies to reach recruitment and retention goals.
Strong Site Relationships
Pediatric sites must be carefully selected or a study can quickly stall. We work closely with sites to lower the risk of lengthy negotiations, deficiencies, and queries. Medpace leverages our relationships with investigators for more accurate feasibility, faster recruitment, and improved retention, allowing Sponsors to meet project milestones in these challenging studies. Additionally, our experience working with academic groups and pediatric research networks is a fundamental contributor to successful enrollment and start-up.
Pediatric Clinical Trial Experts
Medpace’s scientifically-driven approach to pediatric clinical research gives Sponsors the advantage of early and ongoing insight and guidance from therapeutic experts throughout the trial design and execution. Our team of in-house pediatricians are embedded throughout your study and have extensive clinical experience treating sick children as well as designing, conducting, and managing pediatric studies. Our team of in-house physicians provide strategic direction for study design and planning, train operational staff, work with Investigators, provide medical monitoring, and meet with regulatory agencies.
The Medpace Global Regulatory Affairs Team helps Sponsors develop strategies and navigate the requirements for complex pediatric trials. Our dedicated team helps formulate pediatric development strategies (Pediatric Study Plans (iPSP) and Pediatric Investigation Plans (PIP)) as well as coordinate each aspect of engagement — balancing strategy, data, analysis, and timelines by globally optimizing regulatory interactions and strategic approaches. Additionally, our start-up teams understand country specific and regional regulations, enabling us to develop proactive solutions to regulatory issues and challenges within achievable timelines, ensuring your trial is initiated on-time and on-budget.