Capabilities
Pediatric Strategy, Planning, & Compliance
To optimize pediatric clinical trials, partner with I‑ACT for Children
Children represent one of the most vulnerable groups in clinical research, requiring unique study conduct and regulatory and ethical considerations.
Efficient pediatric clinical trials start with a thoughtful plan and data-driven approach. IACT4C is a neutral forum that helps align stakeholders regarding approaches to study designs, feasibility assessment, and other aspects of pediatric product development planning. It also serves as a resource to sponsors providing an independent evaluation of pediatric programs and protocols.
The goal is to “get it right the first time” by early and continuous engagement of stakeholders, including patients and parents. The objective is to avoid costly and time-consuming delays and create trials that are of optimal medical value, feasible/efficient to conduct, and have early buy-in by patients and investigators.
Subject Matter Experts
The guidance you need for more efficient pediatric research
Our global group of pediatric experts and investigators advise ensuring that pediatric studies are thoughtfully designed to meet regulatory requirements and address the specific health needs of children. The experts’ advice is based on a deep understanding of the intricacies of the pediatric population, including ethical and regulatory considerations and the many operational complexities involved.
Some ways our efforts can make a difference:
Pediatric Research Site Network - Regulatory Quality
Accelerate your pediatric clinical trials with a pre-qualified and experienced site network
The demand for pediatric clinical trials far surpasses the number of available investigators, sites, and patients. With access to IACT4C’s Pediatric Research Site Network, clinical trial sponsors can improve study execution.
Through the Pediatric Research Site Network (PRSN), IACT4C supports and manages over 70 trial-ready pediatric research sites serving all therapeutic areas, including oncology/hematology. Our network is focused on advancing regulatory approvals and informed labeling decisions. All sites in the PRSN undergo a rigorous pre-qualification process. This process ensures that every site brought into our PRSN is in good standing and has the experience and resources to conduct pediatric trials safely and effectively.
Each site in the PRSN has a point of contact (POC) and our experienced Clinical Trial Managers nurture the relationship with the POCs and other key clinical researchers by engaging regularly to keep our “finger on the pulse” and to provide support and get feedback. The POCs also ensure that all research staff are aware of and have access to the IACT4C educational resources.
Having trial-ready sites vastly improves the process for site identification, patient enrollment, and trial execution across all pediatric diseases. By working together and supporting the Sponsor or CRO operations team, we aim to streamline operations, reduce study start-up timelines and improve enrollment and retention.
Ways the Site Network Accelerates Study Delivery
- Sites are committed to faster study startup timelines, boosting patient recruitment and retention
- Sites are assigned an IACT4C Site Champion and Point of Contact to facilitate more efficient communication and enhance site and investigator engagement
- All sites are encouraged to utilize a central IRB
- Facilitate Master Confidential Disclosure Agreements (MCDAs) and Master Clinical Trial Agreements (MCTAs) between sponsors and sites
- Facilitate and support successful Sponsor/CRO - site relationships, peer-to-peer engagement with investigators, study coordinators and study nurses
- Provide ongoing continuing education and mentoring programs for all site network members
- Communication tool across all sites to interact and share information