DIGITALIZATION OF CLINICAL TRIALS DATA MANAGEMENT TO IMPROVE DATA QUALITY

Clinical research is one of the most significant aspects of drug development. With advancement in exponential technology and evolving transitions from disease-centered to patient-centered approaches and ever higher regulatory standards, strategic and organizational dimensions of clinical data management (CDM) are quickly changing. Traditional data collection processes are not sufficiently robust to sustain data volume and speed generated during the product life cycle. Electronic Data Capture (EDC) is now becoming an ever-popular solution for streamlining data collection, which gathers clinical data electronically rather than on paper.

Secure data storage and efficient processing of data are also a challenge. It is difficult to capture, process, analyze, document and exchange the data efficiently and cost-effectively with non-intraoperative legacy enterprise systems. The manual transfer of clinical data , for example demographic, safety and access, is inefficient and susceptible to errors when many members are involved in the clinical trial ecosystem. Furthermore, the complexity of operations with multiples versions of data processing procedures and varied technologies used in internal, outsourcing and offshore operational processes is increased by acquisitions and extensive reworking. Trust in data is a permanent challenge and organizations must ensure that the collected data is reliable and accurate.

Data obtained from various sources, including electronic evaluation of clinical outcome, and types of electronic cases are subject to strict regulatory requirements. If clinical records are not handled properly, pharmaceutical firms run a risk of failure to comply, which leads to heavy fines and credibility damage. In order to achieve compliance, data integrity and inspection readiness are necessary, and traceability and auditor ability of information must be improved by means of end-to – end digitalization.

Therefore, we need to accept more patient-centric data gathering criteria to encourage sites and patients to provide exact details of the questions placed in their Case Report Forms. It is considered the future to minimise manual interventions in data collection where solutions allow the incorporation of EHR / EMR play an important role. Using medical devices to capture patient data directly helps to calibration of data, with minimal to no interventions in automated EDC databases.

Make the move to EDC

The advancement of EDC technology impacts the data management environment of clinical trials and provides various advantages for the industry. EDC was initially slow to implement paper-based processes, but users can do much with EDC that can not do with CRFs or regular databases, providing strong investment case. In recent years, the use of EDCs, with paper CRFs only now being taken into account for very specific criteria, has seen a major change. The workflow of safety data with EDCs allows centralized data collection with limited manual data transfer interventions from a variety of sources. With EDC solutions, setup and tracking integration time and effort is saved. Overall, manual interference in the overall data flow guarantees limited possibilities for improved data quality.

Ultimately, EDC provides users with easy access to clean data at low running costs following correct device selection and development as well as effective study management. Switching to EDC has been reported to reduce the time taken to perform a clinical trial study by an average of 30 per cent.

Conclusion

In order to effectively process data obtained from many sources in real time, the pharmaceutical industry has to accelerate their digital transformation and modernize  its conventional CDM systems. In addition to regulatory enforcement and data-centric strategic decision-making, the emphasis on automation technologies needs to be substantially modified. Digitizing and advanced analysis processing across the entire chain of clinical data significantly decreases data collection time, speeding up regulatory submissions and approval procedures, and thereby reducing the time and expense . If you want more details on how we can help you for your clinical trial ,Drop an enquiry