The Utilities and Benefits of Electronic Data Capture Software in Clinical Trials

 It is now common for people to visit their doctors when they feel sick, and the physician diagnoses the problem and prescribes the appropriate medicine they acquire from a pharmacy. However, the medicines reach there after stringent and regulated tests in human subjects – called clinical trials, whose results are carefully studied by regulatory bodies before they permit marketing. The information from these clinical trials - the data - is immensely important, and researchers take the utmost care to maintain the quality. In modern times, electronic data capture software use has increased significantly. 

What is electronic data capture (EDC) software?

In clinical trials, data about a new medicine or instrument is collected across multiple parameters, and the sample size often increases consecutively. The data is traditionally first recorded on paper and then digitized by recording it in non-secure programs. Afterward, during digital transcription, the data is saved in an electronic Case Report Form (eCRF) – which is sent to the sponsor for statistical analysis. The entire process takes considerable time and risks data quality reduction. 

With EDC software, these two primary issues are solved outset. EDC software is essentially a computer program that stores patient data. So the researchers can input data directly into the software, which will prepare the eCRF by itself and store the data as long as needed. Most of these are now cloud-based, so access from anywhere is not a problem. The number of research teams opting for EDC clinical trials is increasing significantly. In most cases, organizations are opting to build in-house EDC systems. 

Advantages of EDC software

Apart from the time–saving and maintaining the data sanctity, Electronic data capture software also provides several important benefits compared to the traditional data capture system. Some of these advantages are mentioned below:

• Accuracy 

It is not uncommon to enter inaccurate data by mistake during traditional data capture methods. With modern EDC systems, it is possible to add restrictions on the program to prevent the human error of mistakenly entering illogical data. These programs can also automatically calculate parameters for data cleaning. 

• Security 

Recording sensitive clinical trial data on paper or public software is not secure, and one can easily tamper or manipulate them. In the new-age EDC clinical trial systems, the data remains secure in a web-based interface. As separate digital credentials control the access, data protection remains optimum. The restricted permission also enables reduced data manipulation, resulting in statistically significant tamper-free information. 

• Organization 

It is harder to filter out certain required information quickly with paper-based data capture systems. Most Electronic data capture software has in-built search options, allowing the user to find the required information within a few seconds. Moreover, these programs can store every piece of information with greater visibility while consuming less space and paper. 

• Regulatory compliance

EDC software is compliant with the necessary regulations, ensuring data integrity. Almost all EDC software have standard operating procedures to maintain organizational and regulatory policy agreement. So, the researchers will always have scientifically sound data at their reach. 

Increasing popularity

There is no mandatory legal requirement for using EDC clinical trial systems to date. However, the scientific community is slowly getting to know the utilities of this software, and their use is increasing significantly over the years. With its faster, cleaner, and shorter processes – along with more comprehensive and robust analysis - Electronic data capture software is now becoming an essential part of clinical trials and associated research.