PharmaNet has the expertise and hands-on experience to successfully conduct studies in infants, children, and adolescents. Our pediatric-specific services include:
 Consulting on chemistry issues, including age-appropriate formulations |
||
| Interpretation of the FDA's Modernization Act (FDAMA) and Pediatric Rule |
||
| Attention to age-specific informed consent and assent issues |
||
 |
Medical oversight of active clinical trials, with emphasis on patient eligibility and monitoring of efficacy and safety in pediatric populations | |
|
Input into study reports and regulatory filings, including interpretation of age-dependent laboratory and other data | |
| Identifying appropriate pediatric investigators from: |
||
| our database |
||
|
ongoing relationships in academia (including investigators affiliated with Pediatric Pharmacology Research Units) | |
| community-based physicians |
||
| Monitoring by experienced CRAs, many with prior pediatric-trial experience |
||
|
Implementing strategies to boost enrollment, consistent with applicable ethical and age-based standards | |
Our experience in pediatric studies includes:
| Drug/device for delivery of local anesthesia in children |
| Type II diabetes mellitus in children and adolescents |
| Cystic fibrosis |
| Juvenile rheumatoid arthritis |
| Oral yeast infection |
Phillippa Smit-Marshall, MD Executive Medical Director, Europe and Asia-Pacific Dr. Smit-Marshall trained in pharmacology and internal medicine in the UK before joining the pharmaceutical industry nearly 20 years ago. During that time she has worked for both industry and CROs and she has been involved in the development of drugs in children across several indications including epilepsy; growth disorders associated with renal failure; intrauterine growth retardation and Turner Syndrome; cystic fibrosis, and schizophrenia. Philippa chairs the institute of Clinical Research’s Special Focus group on Pediatrics. |
504 Carnegie Center, Princeton, NJ 08540