Clinical Trial Technology And Complexity In The Real World – Why You Need A Flexible Edc System

By Author: Giselle Bates
Total Articles: 27
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The concept of EDC (electronic data capture) systems in clinical trials was first introduced over two decades ago. However, these archaic legacy systems are in no way equipped to deal with the sheer volume of data captured in a modern clinical trial. Over time, software firms offering an EDC system for clinical trials have established a significant market for their solutions, and yet innovative intuitive functionality is still lacking in most.

The idea of “if it isn’t broken, it doesn’t need fixing.” has held back innovation in the EDC tool system segment resulting in inherently flawed systems that could cost sponsors millions, not to mention years of wasted time.

As data management teams cope with the increasing complexity of trial design and protocol amendments, the fragility of legacy EDC software systems is becoming increasingly apparent. An inability to adapt to change and frequent downtimes are issues that can be worked around but they place an unnecessary burden on data management teams, resulting in fatigue, error, and most importantly, delays. In short, “It works well enough” just doesn’t ...
... cut it anymore. In short you need a highly efficient yet flexible EDC system.

This is where Octalsoft’s EDC system states its superiority as the best EDC software. Here are four ways Octalsoft's EDC solves these legacy challenges.

1. Capable of including Amendments with zero downtime

Existing EDC software systems are frequently cited as a source of customer dissatisfaction, given the frequency with which they crash anytime there is a change.

The fundamental database foundations of a traditional/legacy EDC are too rigid, which means that any time there is even the slightest change, the primary data structure needs to be reconstructed from the ground up.

In the fast-paced setting of a modern clinical trial, it is simply no longer acceptable to shut down the EDC software for hours at a time due to a large number of amendments and pivots that frequently take place in clinical investigations.

The contemporary and adaptable data structure of Octalsoft's regulatory compliant EDC system makes it possible for adjustments to be made with no downtime, removing the necessity to migrate data whenever an amendment is made and preventing end users from being kicked out of the system. This is more than just "no system downtime," it is in fact "no downtime for end users."

2. Maximizing Custom Functions
Every clinical trial is unique and hence requires an EDC that can adapt to the trial's specific requirements. Being forced to invest in additional systems just because the functionality of the EDC is sub-optimal is an expensive and wasteful approach. Octalsoft’s EDC tool includes every functionality that a modern clinical trial could need inclusive of a cloud-native platform and customization opportunities so that your EDC scales in tandem with your objectives.

Octalsoft's EDC software can handle complex edit checks directly from the system without requiring any external programming. Users can also organically add assessments, set derived values, and override targeted Source Data Verification in addition to emergency protocol deviations with minimal effort.

3. Intuitive and Effective Study Builds
Building out intuitive and effective studies is yet another essential component of efficient EDC tools. The integrated environment of Octalsoft’s EDC offers a simplified study builder functionality that allows users to do so in much shorter time frames without having to hand over control to development execs to convert protocols to code.

The Event Group functionality allows designers to work collaboratively within a single environment that ranges from individual treatment arms to a full sub-study of the master protocol. Subject Groups support named groups to facilitate seamless tracking and reporting.

The Octasoft EDC system validation difference report compares two distinct versions of a casebook. It identifies modifications for accurate User Acceptance Testing (UAT) by focusing on specific items, thus significantly reducing time and cost when it comes to including amendments.

Form Linking allows the user to establish a bi-directional connection between forms so as to easily capture relevant insights without switching between screens. e.g. An adverse event could be connected to its corresponding medication.

4. Enhanced UX
Handling the need gaps of legacy EDC software systems served as a strong foundation to build upon. Octalsoft identified the opportunity to make the entire user experience of our EDC a lot more streamlined and enjoyable for our users.

Octalsoft’s EDC user interface is designed to be both modern as well as deeply intuitive so that the user can navigate the system easily without spending hours in training sessions. There are many additional functionalities within our EDC system that make for a stellar UX.

The Autosave feature allows users to never lose any data, eliminating the stress and data loss) associated with systems timing out.

The EDC’s quick view feature offers CRAs and DMs an expansive yet cohesive view of task statuses. This is a massive upgrade from the form-by-form navigation of a legacy EDC. It does away with cluttered fields that are irrelevant to the task at hand.
This feature is designed to help users work in a way that is comfortable and yet does not compromise productivity or output quality. CRAS can now work incrementally without having to launch tiresome manual searches for every byte of data.

In Summation
Better features lead to an enhanced user experience and better UX leads to enhanced productivity and efficiency. This in turn results in better data and thus a better study. But our spirit of consistent innovation doesn’t stop with our EDC. As a core component of our eClinical suite Octalsoft's EDC is simply the starting point for revolutionizing clinical data management.

Interested in knowing how you can streamline capture, analyze, and report clinical trial data with the utmost precision? To find out, Book a Demo with us NOW!