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Monitoring and Managing

Managing clinical data is a critical aspect of running an effective clinical trial. Patient data needs to be collected according to the study protocol so that statistical analysis of the data can be conducted to prove the hypothesis of an investigational medicinal product (IMP). Effective data management is also key to helping drug companies achieve targeted costs and timelines, as the quality of the clinical data is the backbone to ensuring a successful trial that demonstrates a drug is safe and fulfils its desired effect.

Data can be managed in many ways during clinical trials, whether that be with global standardised data formats for regulatory submissions, electronic data capture platforms that are fully validated and compliant, or bespoke case report form (CRF) designs to ensure all the right data points are captured.

Data Infrastructure and Process

Establishing a robust database is key to the success of any clinical trial. The database architecture must allow all the data points required for the analysis to be collected as per the protocol, without ambiguity and in a way that can be traced back to the original source data (records at the clinical site) for each patient involved in the study.

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Praveen Dass is the country head and Vice President of clinical data management for Quanticate. In his role, he is responsible for operations at the company’s office in India and is the global head of data management. Praveen has extensive leadership experience across large full-service global CROs and large multinational business process outsourcing service providers. He started his career in clinical research as a clinical data management operations manager and has since been responsible for building and managing service delivery teams across varied functional domains such as clinical data management, pharmacovigilance, and programming. Praveen also serves on the Society for Clinical Data Management Steering Committee in India.
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Praveen Dass
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