Clinical researchers deserve a great deal of credit. Bringing a new medical product to the marketplace today means negotiating a wide range of obstacles, from recruiting of patients to adjusting regulations to growing costs for research and development. In the wake of all this, the determination of clinical researchers to stay focused on their objective of preventative medicine and life-saving is why we find clinical research so inspiring.
But it also poses the question: what can we do to resolve this rise in complexity and cost in clinical trials to ensure that they do not inhibit our ability to provide life-saving therapies to people in need? How do researchers change their workflows in order to respond to these challenges? The industry has addressed this question in a variety of ways – the eSource revolution and the advent of virtual and hybrid trials are just a few of them.
Another strategy that has been gaining momentum: the design of innovative clinical trials. Any company finding ways to keep their research going forward in the face of increasing costs and uncertainty should determine whether innovative approaches to the design of clinical trials will improve their progress toward their objectives. At this pivotal moment for our industry, it is a smart idea to look at the advantages of being able to track data from sites in real time and to retain control of data quality and patient safety.
Clinical Studies Electronic Data Capture System (EDC) Specifically built for small and medium enterprises
In many areas of our everyday lives, technology has substituted paper-based approaches, but some research sponsors still rely on obsolete paper reports for critical clinical trial data capturing. In the context of the entry of data, the composition of the database, and the conduct of research in clinical trials, Electronic Data Capture(EDC) is used to support medical devices and pharmaceutical organizations. EDC technology has advanced as questions about data privacy have become something of the past due to human error and problems with communication caused by less trustworthy IT systems. During the last decade, EDC has become increasingly popular in clinical trials.
The amount of information collected before, during and after clinical trials continues to increase as the medical industry embraces emerging technologies and developments, including electronic record keeping. Thus, extensive data collection and effective management are now a priority for pharmaceutical and clinical research firms (CROs)
Electronic data capture upsides:
Collect reliable data in paper form from clinical research can be easily established, data quality and smoother. Electronic data acquisition (EDCs) is a way to collect clinical trial data of high quality. The benefits of EDC and how clinical trials are improved are necessary to understand:
Configure studies in days, not months with our easy-to-use and built-in gui. Depending on the method you chose, it may be reasonably straightforward to start a full clinical trial in an EDC system.
Improves quality of data
EDC System is an essential tool for developing and storing electronic case report forms (eCRFs).This ensures correct data, flag errors or results are lacking predetermined parameters. Program editing in eCRFs prevents unnecessary or irrelevant data from being collected before data is entered, making sure only logical values are registered.
Accelerate completion of research
The EDC method helps trials to be conducted more efficiently because it streamlines the work needed to perform a trial. Forms are generated, data is entered, queries are resolved, and data is locked in a single structure, in real time. This decreases waiting time and/or travel time for monitors, data managers and coordinators, and the faster they complete their part, the closer the study will be to completion.
Make it easy to find what you need
The EDC approach allows registered users with an Internet connection remote access to clinical data from any geographical area. You will spend less time thinking about where to hold your forms because patient data is processed and backed up securely in a cloud-based system. Since all forms are available in one location, it is also simple to reuse them through multiple protocols.
It’s more stable
The data reported on paper can be modified in a way that is almost impossible to detect. The EDC system has an audit trail feature that monitors any shift. Since patient safety is a major concern, data can only be accessed via role-based permissions in the EDC system. Electronic signatures require a specific username and password to log in and perform those activities. Many technical safeguards must be in place for the EDC system to be compliant, including the 21 CFR Part 11 guidance issued by the FDA. You need to start with a validation system ready to complete the validation process.
The Trovend e-CRF offers a fully featured, 21 CFR Part 11 EDC compliant solution, providing both investigators and monitors with a powerful but easy-to-use data entry and monitoring environment. Trovend’s e-CRF facilitates all steps of the clinical trial process, from the translation of the clinical trial protocol to the consolidation of all data obtained, ready for reporting and review. It is accessible online and can be accessed safely from anywhere by registered users.
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