- July 30, 2021
-- Clinical data management is the actual development, execution, and supervision of plans, programs, policies, and practices which control, deliver, and protect the value of information and data assets in clinical research courses or study. CDM has diverse connectivity with several cross-functional features, which has come a long way over the last few decades. It is a recognized profession that has a growing demand in today's research world. It is gaining importance even outside the pharmaceutical and medical world.Challenges in clinical data management
The medical device industry, biotechnology, pharmaceutical industry, academia, and government have now understood EDC's efficiency and benefits. Although the main aim of CDM shall not change, there is no room for doubt that the management process shall transform with the use of EDC and other e-clinical systems. The major challenges include:
- Clinical form design and balancing needs: There are interdisciplinary several CRF design challenges that involve technology, protocol-driven science, validation, work-flow, and standardization usability for EDC studies. The final report, which is the product of complex computer programs and statistical analysis, is dependent on the data collected in the CRF. The entire data collection process, including checking, analyzing, and presenting it, is done using sophisticated technology and employing highly skilled professionals. The growing need for post-marketing data acquisition in large-populations for safety studies presents multiple challenges, including collecting, integrating, and analyzing lists of growing data sources.
- Sensitive clinical operation with process re-engineering: This is another challenge faced during clinical process re-engineering to make sure that EDC studies are planned and implemented in the context of addressing clinical support and safety process improvements. The organization needs to optimize daily clinical operations. The trend of outsourcing this aspect continues to grow, as many organizations increase the percentage of trials performed by CROs. While outsourcing, one must realize that there are several issues present, including data safety. The knowledge and integration give the long-term value while placing the right people for the job.
- Continuous technology improvement: The challenge also lies in the improvement of technology and its flexible configurations. Several interconnected clinical systems can participate and support a clinical research trial operation, showing the need to use contextual systems processes while investigating and resolving any probable issues. Today's technology-enabled environment, clinical data management, and willingness to improve among several groups are the key to engendering clinical efficiencies and cost benefits.
- Clinical research professionals that are gone through the best of clinical research training (https://www.clariwell.in/best-clinical-research-courses-i...) have to anticipate and embrace attentively to prepare for the further challenges from both systems and business engineering perspectives.
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