Clinical trials have been a complicated and time-consuming affair. Specialists and global authorities have recognized that a reliable and stable data management strategy is essential to the achievement of any specific study objective.
There will be various procedures, continuous supervision and thousand participants participating in each clinical trial. More specifically, a clinical trial typically involves the production of heterogeneous multi-site data with complex formats and inputs. Data can vary from personal details, assignments to teams, logs for medical errors, laboratory results questionnaires.
It is necessary for each study therefore to have accurate, readable, clear, usable and secure data. Furthermore, all methods for collection of data should comply with global ethical legislation and best practices
Paper Vs. Report forms on Electronic Case
In Clinical Research, while ‘one model cannot suit all,’ it is generally possible to divide data collection into paper and electronic formats. Data collection may historically be conducted with the summarization of medical records, laboratory observations, and graphs on paper case report formats (pCRFs). However, it is a time-consuming and error-prone process. There can be readability difficulties, which can also become an audit barrier.
As they are connected with facilitated data monitoring and processing, improved data quality and applicability, and audit facilitation and compliance, eCRFs have become a major element of good source documentation practice. eCRFs allow speedier processing of databases and short study times. In addition, studies show that the use of eCRFs eliminates failures, errors, costs and logistics for transportation. Last but not least, for multi-center trials, eCRFs are particularly useful.
In the process of clinical trials, electronic case report forms (eCRFs) are used to collect patient data. They play a key role in assessing the safety and effectiveness of medicinal products. The collected data must be reliable and full to be effective in a report. Forms must be accurate and complete with close attention to detail. You must comply and document the specifics of the procedure for review. And regulatory standards such as those specified in the FDA must also be met.
In the long run, the fact that eCRF architecture and the use of EDCs provide much more advantage than using conventional paper methods has been confirmed. In addition, the FDA promoted the use of EDCs to simplify the research process and minimize costs.
Five reasons for design of eCRF over Paper CRFs
Data and quality controls in real time;
Better output in data management (less errors in data entry).
EDC systems increase the quality of data considerably. Computerized system enablers readable data, and cleaner data is assisted by automated calculations.
Site data entries;
Access to real-time;
Unified base of data;
Less time for query management.
For each new analysis, digital models are easily modified. Data are only obtained and entered once in the system. The data would normally first be registered on paper (CRF) in a paper-based process and then then entered by the team of data entries in the system and stored in an eCRF. This is not only time consuming, but error-prone process, though well-established.
Backed up data;
Applicable permissions for users and functions.
Software providers ensure the data is safeguarded and secured. Online hosting of the framework. Each User account has designated permissions, and only those holding those roles can perform most acts.
Integrity of data;
Verification of electronic data sources.
An electronic data capture system must follow regulatory criteria and specifications. SOPs are also expected to ensure compliance with regulatory and organizational standards (standard operating procedures).
Researchers can increase patient safety by using electronic solutions. Today EDC systems are the best way to data capture sponsors and researchers as a result of the dramatic changes in clinical test performance arising from the COVID-19 pandemic, including numerous deviations to resolve patient safety.
Today, several research and biotechnology organizations, via innovative technologies to promote clinical trials, realized the advantages of EDC over paper CRF. In several software providers new functional features and upgrades are continually introduced to keep up with market changes. To make it more flexible and useful, Trovend Technology has produced most user-friendly applications in this process. So you can build your own database on your own computer according to your own specifications along with these advanced features of the Electronic Case Report Form.
In addition to collecting high quality medical information, this application will organize the collected data very appropriately to speed up some of your medical research or study work. You would now think that this program will definitely be extremely high in price now that you heard all these kinds of advanced functionalities and applications, at trovend we will provide it at the fairest price.
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