Clinical Data Management; Ensures Collection, Integration, and Availability of Data
Clinical data management (CDM) is a process of collection, integration, and management of clinical data in compliance with regulatory standards. A collection, documentation, and storage of clinical data is important for clinical procedures or trials and to pharmaceutical and biotechnology companies. This leads to the generation of statistically comprehensive, reliable, and high-quality data to reduce time duration from drug development to marketing. Clinical trials have become extremely important to human health and prevention against many diseases.
In the clinical trials, the investigators must collect
sufficient details about the subject. This information is valuable as it helps
the researchers in the future research activities related to the product.
Proper clinical data storage and management is very crucial. Clinical data
needs to be maintained in a standard way to avoid corruption, loss, or
alteration of important data. The data
collected from multiple sources is captured in a paper or electronic format, and
stored in a data repository, in a patient-centric fashion, known as clinical
data repository.
IT companies, contract research organizations (CROs), and pharmaceutical
companies are involved in clinical data management activities. Clinical data management outsourcing is done by the organizations to focus on core
competencies of clinical research and pharmaceuticals, investment in research
and development activities, and reduction in operational expenditure. Moreover,
clinical data management is the primary means of patient records, which include
demographic, clinical, and demographic information, vital signs, laboratory and
radiology information, information regarding medications, and trial information
such as subject name, number assigned to each patient, reasons for
discontinuation, reason for withdrawal, etc.
Clinical data management can help the clinical research
organization in many ways such as designing the efficient data storage and
clinical records as well as helping the clinical team in data warehousing,
deployment, software maintenance as well as other CDM activities. With the
increasing number of clinical trials, the demand for clinical data management
is also increasing. For instance, in November 2020, China’s vaccine developer, CanSino
Biologics Inc. launched Phase III clinical trial for its COVID-19 vaccine in
Mexico.
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