Abstract

CLINICAL DATA MANAGEMENT(CDM) PROCESS STANDARDIZATION FOR VACCINE TRAILS IN AN INDIAN PHARMACEUTICAL COMPANY UNDER INDIAN REGULATIONS

K. Pooja*, M. V. Nagabhushanam, A. Jaya Tejeswini, G. Kavya Latha, Brahmaiah Bonthagarala, G. Ramakrishna and Y. Ratna Sindhu

Abstract

Framework that might emerge from establishing CDM procedural paths could improve clinical data management practices and thereby supporting regulatory compliance. India is fast becoming hub for vaccine research and development. Efficient and quality clinical data management remains a challenge. Effective CDM not only support consistent performance desired to meet increasingly tough and an inherently dynamic regulatory compliance requirements but it also drives all stages of drug development economics both prior to and subsequent to product registration and marketing, addressing key challenges not limited to the following. Such clinical scales are also the need for regulatory review to aid in drug development procedures as per GCP. Standardized CDM definitions, the process of developing and implementing technical standards, CDM data formats are needed to optimize data management. There are concerted efforts in the pharmaceutical industry to adopt a common data standard in various aspects of clinical studies and product development, for example, CDISC (standards for the interchange of clinical, non-clinical, laboratory, and statistical data) and GMP.

Keywords: Clinical Data Management (CDM), Vaccine Trails, Good Clinical Practices (GCP), CDISC (standards for the interchange of clinical, non-clinical, laboratory, and statistical data) and GMP.