Pediatric Services Extending Across the Continuum of Drug Development
Our expert team of physicians and pediatric development specialists uses its deep experience and knowledge of the clinical development landscape to create a meaningful strategy and plan to guide and execute your clinical trial.
With our broad range of services, we assist clients in conducting pediatric studies at all stages of development. Specifically, our expertise includes:
- Insight into protocol development, feasibility, study design and study-related issues based on knowledge of current standard of care and regulatory trends, representing each geographic area of clinical development
- Strategic consultation internally and externally on pediatric product development, through multidisciplinary clinical teams with firsthand knowledge of challenges and risk mitigation strategies regarding consent/ascent, recruitment and retention that can streamline operations in global clinical trials
- Consultation with sites on the appropriate regulatory structures and processes and access to investigators with relevant pediatric expertise
- Participation in pediatric regulatory activities to assist with development and execution of global regulatory strategies and dossier preparation
- Broad awareness of the global pediatric development landscape
PPD’S EXPERIENCE IN THE PAST FIVE YEARS:
Global Presence, Local Experts
“We are passionate game-changers, working to reduce unmet medical needs and provide for actionable data serving pediatric patients and families. ”
Pediatric Investigator Network
PPD’s Pediatric Investigator Network (PIN) is comprised of 14 pediatric academic centers of excellence established to speed and optimize the development of therapies for pediatric populations.
Our PIN partnerships give us direct access to pediatric thought leaders and principal investigators across relevant therapeutic areas, helping to facilitate rapid feasibility and protocol input to develop clinical trials that are practical and operationally sound for children. These research-experienced sites also serve as key centers to support the evaluation of new pediatric medicines.
Significant Experience in Pediatric Research
In addition to client consultation, PPD’s pediatric team provides support and consultation to internal study teams during study conduct to maintain continuity of operational execution.
We bring a deep understanding and knowledge of this unique population, enabling us to identify investigators and sites with relevant expertise.
Rare Disease and Pediatric Center of Excellence
Our Rare Disease and Pediatric Center of Excellence team provides tailored thought leadership and innovation in the design and execution of rare disease trials, as well as aligned oversight of program delivery for operational teams. The Center of Excellence offers access to more than 20 rare disease experts who provide strategic insights, across all therapeutic areas, that inform and optimize clinical and regulatory strategy development.
Our deep commitment to advancing research has led us to develop patient-centric solutions to reach, recruit and retain small, globally dispersed populations including:
- Patient-centered research conducted by Evidera to evaluate patient, clinician and caregiver outcomes, utilities and preferences
- Patient concierge that serves as a single point of contact for patients to proactively guide them through participation and manage the logistical aspects of a clinical trial
- Engagement with patient advocacy groups to incorporate patients’ voices into study designs