Monday , 6 February 2023

Clinical Data Management Process Standardization for Vaccine Trials in an Indian Pharmaceutical Company, Under Indian Regulations

C. Raviteja*1, K. Sunil Kumar2

1Department of Pharmaceutics-DRA, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India.
2Associate Professor, Department of Pharmaceutics-DRA, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India.

A  B  S  T  R A C T
Introduction: Biomedical research studies on human subjects are done under strict ethical and regulatory framework. The data generated from a clinical trial serve to draw scientific inference, therapeutic or prophylactic spectrum, and as evidence that an investigational product is safe and effective for use in human. Aim and Objective: The aims and objectives of this study were to interpret, implement and standardize CDM procedures in a manner to support data output as needed by Indian GCP, meeting audit requirements and thereby enabling regulatory compliance, for vaccine studies. Methods: A survey was conducted to glean in industry perspective of the needs and challenges of CDM practice in India. The survey indicates lack of industry wide common CDM data standard. The ECRIN data management centers survey was used as a reference for the questionnaire. Anonymous input was used and the names of respondents are not disclosed to maintain confidentiality. Results and Discussion: About 58.70% (27 of the survey participants) had the relevant experience of more than 5 years in the area of clinical research. While, 36.96% (17 in number) was from the group with an experience of ‘1 -5 years’ and 4.35% (2 in number) had the experience of less than 1 year. Implementation of CDM procedural steps based on industry prevalent best practices in the context of vaccine clinical trials in an Indian Pharmaceutical company, within the scope of Indian GCP regulations. Conclusion: It is concluded in this study successful implementation and standardization of industry prevalent CDM best practices, validated by QA department, for in-house vaccine trials conducted by an Indian pharmaceutical company, under the Indian regulatory frame work of GCP, was achieved.
Keywords: Bio medical research, regulatory affairs, vaccine trials, GCP, clinical trials 

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