3 - Specific competencies and capacity to provide export advice
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
TEDDY - European Network of Excellence for Paediatric Research |
|
| Number of peer reviewed publications in the last 5 years | 62 | Please refer to Annex 2 |
| Number of competitive grants obtained in the last 5 years | 7 | Listed publications have been either performed on behalf of the Network or derived by TEDDY activities. |
| Access to expert groups | Yes | PA/UNEPSA- European Paediatric Association, SIOP Europe, EU Society for Paediatric Endocrinology (ESPE), EU Society for Paediatric Infectious Diseases (ESPID), EU Respiratory Society (ERS), Società Italiana per le Malattie Respiratorie Infantili (SIMRI), EU Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN), Società Italiana di Pediatria (SIP), Societé Francaise de Pediatrie, Asociación Española de Pediatrïa (AEP), Sociedad Española de Infectología Pediátrica (SEIP), Società Italiana di Ricerca Pediatrica (SIRP), Thalassaemia International Federation (TIF), Società Italiana di Farmacologia (SIF), European Society of Developmental Paediatric and Perinatal Pharmacology (ESDPPP). |
| Capacity to answer external scientific questions | Yes | Among others, TEDDY includes expertise in: - clinical trial management; - methodological aspects of clinical research, innovative/traditional studies design, monitoring and statistical evaluation, recruitment capacity; - formulations; - pharmacovigilance and longterm studies; - ethics (advise on documentation to submit to the ECs including assent forms tailored by age, ethical provisions including third countries); - PKPD studies (population PK study modellisation, extrapolation). |
| Site feasibility | Yes | Assessed case by case on the basis of a ‘feasibility questionnaire’ prepared according to the peculiarities and needs of each specific trial. |
| Participant recruitment | Yes | The Network is able to ensure the participation of third countries in some therapeutic areas. A consistent and meaningful communication with site personnel is promoted and established and study progresses for each trial are timely communicated through regular newsletters and updates and alerts on the Network and projects websites. Regular monitoring visits are performed to verify that the patients safety and well-being are protected, the reported trial data are accurate, complete, and verifiable from source documents and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s). |
| Budget calculation for studies | Yes | The Network regularly provides budget calculations for clinical trials and agreements, including financial distribution site by site. |