Since the outbreak of Coronavirus (COVID-19), the pharmaceutical industry and the CROs have been dealing with a long list of issues, and the top of the list is to ensure the consistency of the trials. With evolving obstacles to registration, start-up research, patient retention and site visits, the situation calls for alternative models to be used by sponsors, such as the use of advanced technology to help companies ensure continuation of trials with limited risk and the highest level of compliance.
Digital technologies will advance how companies approach clinical studies by integrating useful data from diverse data sources, significantly enhancing patient experience, increasing the effectiveness of clinical trials, and increasing the number and quality of data obtained in trials. Investment in resources and time is required to ensure that each trial database is thorough. If companies do not make this investment, there is a possibility that improvements or additions will be made later, which will be expensive and will have wider consequences for operations.
Make the transition to the EDC
The introduction of EDC technology is transforming the data management system of clinical trials, bringing many benefits to the industry. Adopting EDC instead of paper-based approaches was initially sluggish, but users can do things with EDC that they can’t do with paper case report forms (CRFs) or standard databases, making a strong justification for investment. In the last few years, there has been a significant change in the adoption of EDC with paper CRFs being considered now for very specific requirements. EDC is used to help medical devices and pharmaceutical companies achieve optimum productivity in data entry, database structuring and clinical trial research.EDC technology has progressed as previous issues about data privacy have become a thing of the past due to human error, and compatibility problems caused by less effective IT systems. Hospitals all over the world are better equipped, workers are much more comfortable with electronic systems, and customers are now much more informed of the time that can be saved by using EDC.
Digital templates are easily changed to accommodate any new research, saving time that would be spent on designing and processing paper CRFs. On average, it has been shown that EDC decreases pre-study preparation time by 41%. Using EDC, data is collected and inserted into a data collection tool only once, for a paper system , the data must first be inserted into a case report form and then entered into an electronic system by a data entry group.
EDC also allows data management to take place immediately and does not require extensive work by a data management department for processing. Unlike paper studies in which the data management department conducts logic checks against data collected weeks or months ago, EDC system logic checks are carried out when the site enters and submits data , allowing it to be maintained in real time.
Nowadays, many research and biotech organizations know the advantages of EDC over paper CRF and exploit emerging technology to facilitate clinical trials. In this phase, Trovend Technology has developed the most user-friendly applications to make it more flexible and useful. So, along with these advanced features of the Electronic Data Management System, you can easily build your own database.
This framework would not only collect high-quality clinical data, but would also manage the data collected in a very convenient way to speed up some of the clinical research or study work. In view of the substantial reduction in time from data collection to database release, Trovend Clinical Trial Data Management systems ensure a commitment to minimize related research costs.
Please contact us today to know how we can support your clinical trials data management.
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