The benefits of EDC software/ CDMS in clinical data management are recognized by major skate holder such as GSK, Merck, Novartis,… and they are planning to use CDMS in 100% of their clinical trials.
Clinical Trial need high-quality data
Quality of data collected during the clinical trial is the single most important key to its success. The need for high-quality standards for data used in clinical trials has been acknowledged for more than two decades now. Efforts in quality assurance in clinical data management have been increasing, as reflected in the increase of related publications, books, industry guidelines.
In this context, a conventional method with paper and spreadsheet cannot meet clinical data management demand anymore. Data now means “electronic data”, which is electronically collected, stored, transmitted, and archived data for critical data-based decision making. CDMS (Usually known as EDC) origins actually begin in the mid-1970s with a contract research organization known then as Institute for Biological Research and Development (IBRD). Dr. Richard Nichol and Joe Bollert contracted with Abbott Pharmaceuticals for the IBRD ‘network’ of Clinical Investigators to each have a computer and ‘directly’ enter clinical study data to the IBRD mainframe. IBRD then cleaned the data and provided reports to Abbott. However, this practice was more popular back in the mid to late 1990s.
Today, after a long time of improving and advancing, The benefits of CDMS are recognized by major skate holder such as GSK, Merck, Novartis,… and they are planning to use CDMS in 100% of their clinical trials. Global e-Clinical solutions market is still estimated to reach 7.61 Billion by 2022, at a CAGR of 12.4% from 2016 to 2022. Obviously, EDC has become the industry standard for information analytics in clinical trial management.
CDMS (EDC) will cut study duration by 22%
5 reasons listed below will make you understand why CDMS must be used in clinical trials
- Improving Data Quality
CDMS is particularly good at enforcing certain aspects of data quality. Edit checks programmed into the software can make sure data meets certainly required formats, ranges, etc. before the data is accepted into the trial database. The number of queries while using CDM drop by 86%.
- More Efficient Processes
CDMS can help guide the site through the series of study events, requesting only the data needed for the particular patient’s circumstance at a particular time. It faculties the process of clarifying data discrepancies with tools for identifying and resolving data issues with sites, and can help reduce the number of in-person site visits required during a trial.
- Faster Access to Data
Cloud-based CDMS systems can provide near real-time access to data in a clinical trial. This insight enables faster decision making and can support adaptive trial designs
- Scaling to multi-center study across globe
Today clinical trials are going to expanding and be much more complex that requires trial range is not only multi-center but also multi-national. With a cloud-based platform, CDMS is absolutely able to solve this issue. Data recorded and transited through nations and centers by a cloud-based system will be ensured about secure, identicalness and zero lost data. The data manager can review data occasionally, even on a daily basis so they see the trends in the data more easily, identify queries and flag them for resolution.
- Cost effective and Time-saving
Because of superior advantages comparing to the conventional method mentioned above, using CDMS will help to decline entire study duration by about 30%, cut time to database lock by 43%. The decline in monitor process cost, drop in the number of data entry labor by the sponsor or CRO and other benefits make the clinical data management process total cost go down by 15% compared to conventional method.
Going forward, CDMS is playing a more significant and larger role to make bigger impacts on the clinical trial. It has been performed mostly in trials in Phase 3 and later, and its presence will expand, but it also being considered for earlier studies. With this move, it will be capable to create electronic data sooner on, constantly bringing greater efficiencies and cost savings.