Strategic implementation of CDISC across pharmaceutical companies- an integrated approach
Journal Title: IOSR journal of Business and Management - Year 2018, Vol 20, Issue 9
Abstract
Strategically planned implementation process across pharmaceutical organisations will ease the submission process. It results in increased efficiency, cost effectiveness, avoid unforeseen surprises and it reduces stress for the employees. Although it is a challenging task for implementation and execution of CDISC (Clinical Data Interchange Standard Consortium) compliant dataset, a well-planned submission process will lead to successful regulatory submissions. This avoids re-opening of data bases and helps in smoother submission processes. There is a need for technical expertise and effective cost management implementation process. CDISC vision is to enlighten patient care and safety through higher class of medical research. CDISC mission is to improve medical research and healthcare related areas. The major goal is traceability from collection of data till analysis. Food drug and administration (FDA), Pharmaceuticals and Medical Devices Agency (PMDA), Prescription Drug User Fee Act (PDUFA) has mandated the electronic common technical document (eCTD) format for regulatory submissions. Sponsors need to reconsider whether they need to convert and standardize the data when the study data goes for submission approval or efficiently adapt from the beginning of the trial with the collaboration of global study team. This paper will help sponsors to adapt the strategical implementation process from the beginning of the trial and helps companies to overcome the challenges faced during the implementation. This paper also discusses how feasible is to invest internally or outsource to contractors or consultants considering the cost effectiveness and the skilled resources and validation of work being carried out.
Authors and Affiliations
Alagupriya Somasundaram, Dr. S. Madhavan
Keywords
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- EP ID EP412437
- DOI 10.9790/487X-2009011420.
- Views 36
- Downloads 0
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