|
Data: 19/11/2012
Development. Activities during study conduction:
• Supervision of the correct development of the trials, paying special attention to the rhythm of recruitment, adopting the appropriate measures if needed.
• Supervision of the adequate monitoring of the study by the CRA or external CRO.
• Implementation and maintenance of an adequate relationship with the study investigators, participation to investigators’ meeting.
• Review of adverse events occurred during the study and report to the Drug Safety Manager and Clinical Research Director, ensuring that the procedure is done in accordance with the existing regulations and relevant SOPs.
End of study. Activities after end of clinical phase
• Review (blinded/open) of database; review of listings, medical writing for the preparation of study report;
• Study results presentation/publication. Update of the IB, IMPD and other relevant document (e.g. annual safety report, IND update etc) with the study results
End of Clinical Development:
• Preparation of all documentation summarising the Clinical studies (written summary of efficacy/safety), input to the Summary of Product Characteristics;
• Discussion with regulatory authorities along the approval process leading to the Marketing authorisation (worldwide).
We especially appreciate receiving résumés from the disability protected class, as defined by Law 68/99, which meet the requisites illustrated above.
Per ulteriori informazioni potete consultare il seguente link.
Pagina precedente
|
