Clinical Data Management Helps Overcome Complex Nature of Modern Drug Development and Regulation System

Nov, 2021 - by CMI

Clinical Data Management Helps Overcome Complex Nature of Modern Drug Development and Regulation System


Clinical Data Management is an important phase in clinical research that contributes to generation of reliable, high-quality, and statistically significant data from clinical studies. This aids to make a dramatic reduction in time between drug development and commercialization. Clinical data management also assists in keeping clinical records accurate and up-to-date. It also involves coordination and teamwork among trial investigators, the medical data management system, the database management team, the information security team, regulatory agencies such as Food and Drug Administration (FDA), and the quality assurance teams.

With the advent of molecular biology and other new technologies, pharmaceutical and generic companies are faced with challenges in meeting the regulatory requirements of the FDA and other regulatory agencies. The regulations regarding the protection of clinical samples and information are being constantly revised to improve the quality of care, safety, and the integrity of the process of clinical trials. This has been greatly facilitated by the existence of large clinical trial databases. However, it is essential for pharmaceutical and generic companies to utilize the information generated from clinical trials in a reliable manner in order to meet their regulatory and legal obligations.

Clinical data management system aims at improving the quality of results and minimizing the risk posed by the errors made in data entry, recording, processing, and sharing of the data. It validates the clinical trial's demographic information, clinical data, and other important information such as study protocol and other important documents. It also takes care of the validation process for regulatory submissions and ensures adherence to Good Clinical Practice standards.

Clinical data management system can be implemented in various environments such as clinical research management organizations, hospitals, nursing homes, and patient information registries. Although the system has been implemented in various settings, the most notable use of this application is in clinical trials conducted by pharmaceutical and biotechnology companies. The main purpose of the system is to standardize the collection, storage, retrieval, maintenance, analysis, maintenance, and release of life sciences data and related information.

Clinical data management applications can either be implemented as an on-site clinical research management organization or off-site clinical research management organization. Off-site clinical research organizations may utilize either the EHR or EMR as their main data management system. On the other hand, on-site clinical research management organizations may implement both the EHR and the EMR.

Clinical research associates play a vital role in the entire process of clinical data management. They ensure that all components of the system are functioning optimally. This includes ensuring that all data meets quality standards, maintaining accurate records, checking for errors and omissions, analyzing data to identify trends and developing plans to resolve problems. To become a successful clinical research associate, it is important that you have a comprehensive understanding of how the entire system works.