Clinical Trial & Regulatory Unit
The Clinical Trial and Regulatory Services Unit supports investigators in planning and implementation throughout the drug discovery pipeline. Our remit spans to phase 2 clinical trials and includes protocol development and regulatory guidance. Through the services offered, the Unit provides expertise in the regulatory process surrounding the initiation of clinical trials to investigators with little to no experience in clinical research, increasing the access to translational research for all IDDRC investigators.
We maintain IRB protocols to support the clinical research goals of the other sub-cores within the Clinical Translational Core (CTC). The service collaborates with Patient Advocacy Groups, clinical Centers of Excellence, patients and families to best serve the interests of affected populations in the development of therapeutic strategies. We host scientific conferences, patient and family conferences, and family outreach programs in the Intellectual or Developemental Disabilities (IDD) community.
Contact us
Co-Director
Stephanie Brewster, MS, CGC
Email >
This form is only accessible to users on the BCH internal network.
Current Services
- General IRB/regulatory guidance
- Help with ongoing clinical trials/studies
- Protocol/consent development
- Launching of a new research studies
- Preparation of IRB application
- Recruitment planning
- Budget development
- Study staff supervision
- Study staff training
- Regulatory/patient binder audits
Biostatistics Services
Biostatistics Services provide investigators with study design and data analysis support during the planning phase of new clinical and preclinical research projects.
Research Participant Registry
Within the recruitment services, we also facilitate the Research Participant Registry of the Translational Neuroscience Center. Our team of clinicians and investigators — from cognitive neuroscience, psychology, and genetics work — with researchers to answer important questions about brain development and behavior in babies, children, and adults.
We invite members of the public to become part of our team by signing up for our Participant Registry to stay informed about childhood development studies from infancy through adulthood. Our goal is to gain a better understanding of the healthy development of children and improve outcomes for children and families with conditions such as autism, ADHD, epilepsy, sleep disorders and many others.