ECRF SMARTER PAPERLESS APPROACH FOR CLINICAL TRIAL STUDIES

One of the most significant aspects of clinical research is clinical data management. The key trend in the development of clinical trials is using electronical data management (paperless approach). Any problems emerging in this field will cause many delays and difficulties in processing information. Instead of paper CRFs, eCRF and EDC systems are being introduced, and several of these types of devices are already involved in projects. However, the electronic systems have still not been used by all sponsors and the CROs. There are number of reasons for this, such as higher eSource costs compared to paper, difficulties in the initial use stage, etc.

Electronic resources are implemented in clinical trials as an alternative to paper. Initially, this was achieved in major clinical research (phase III and post-commercialization). The data volumes for these projects are huge, and the compilation on paper and analysis and transformation in a single database was inappropriate. Furthermore, it is difficult to track and regulate the dynamic of studies. This resulted in several mistakes and delays, resulting in losses and complicating the entry to the market of the product.

In clinical trials, electronic resources were introduced as more effective, which is why electronic systems were introduced to simplify and automate most processes. With their support, research can be performed more effectively, mistakes can be reduced when gathering data and clinical research budgets streamlined.This strategy yielded impressive results and led to limited trials. Let us talk about the implementation of this strategy and what motivates new companies to incorporate eSource.

Improved data quality                                                                                                                  

One of the strongest reasons for validating the reliability of electronic systems is enhancing clinical data quality. This section describes EDC (Electronic Data Capture) and eCRF applications. They aid the processing of clinical data inside the electronic system and enter it directly into the database without using paper CRFs.  Paperless approach helps to collect more effective data at the end of the evaluation, simplifies processing and provides accurate information on the product’s efficacy.

Enhanced clinical trial output

The use of electronic systems increases the overall performance of the study.  The use of these systems allows for the whole study to operate faster,

• Increases the study speed. Electronic systems allow you to start your project more than once quickly and reduce your planning time. This is done by using electronic data management systems, which speed up the signature and organize all activities necessary. It also saves the time required to create and distribute CRFs, ICFs, and diaries etc., based on paper. All this is now performed in electronic systems within few weeks and is ready for validation immediately afterwards.
• Reduces delays in clinical trials. Remote monitoring can be effectively implemented using electronic systems such as EDC and CTMS (Clinical Trial Management System). This makes it possible, without visiting the site, to track the dynamics of the project remotely. It helps diagnose and solve the problems causing research delays quickly.

Cost Reduction

Total costs for clinical trials can be reduced considerably using electronic systems. A reduction in delays, for instance, prevents unexpected costs and meets the research budget. Budget optimisation is also accomplished as high-quality data can be obtained instantly by electronic systems.

In some cases it may seem more costly to start electronic systems than paper testing. However, note that the expenses for paper-based experiments are not taken into account: direct costs for monitoring, transport, lodging, data cleaning and the extension of the test. The use of eSource reduces such extra costs and thus reduces the overall project expense.

Enhanced readiness for auditing and monitoring

The minimisation of the use of paper documents simplifies regulatory interactions. All data and documents are collected in one location, through electronic media or an electronic system in this case. This makes it easier for investigators to identify and provide the necessary details, making the company almost always ready for inspection.

In the case of paper data, all necessary documentation can be identified and collected in a timely manner and organized and prepared for search. And selection and systematization are more efficient for electronic systems.

Summarizing

There are many advantages to the paperless approach in clinical trials, like:

• enhance data quality by using eCRF, automated inspections and queries;
• improve the productivity of research by reducing the probability of project delays and problems;
• Minimizing expense of the project by reducing the risk of unexpected expenditures.