The Use Of Electronic Data Capture Tools In Clinical Trials - Octalsoft

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A clinical study is designed to assess the safety and efficacy of a novel therapy. Biostatisticians analyze data from Case Report Forms (CRFs) completed by investigators for each patient during the study to make decisions regarding the outcomes of a clinical trial.

CRFs from clinical studies were formerly performed on paper, packaged into boxes, and delivered from the research site to a secondary location for processing. To gather, store, and manage clinical data, an increasing number of sponsors and CROs are going paperless and employing web-based electronic data capture tools, (also known as EDC systems).

Clinical research managers may use EDC solutions to speed the data collecting process, acquire more accurate data, and improve data security and accessibility - all while saving time and lowering the cost of conducting a clinical trial.

We'll go over all you need to know about EDC Systems and the shift from paper-based to digital CRF record-keeping for clinical trials in this blog.

What is an Electronic Data Capture (EDC) Tool?

An Electronic Data Capture (EDC) system is a software solution ...
... that helps researchers gather, store, and manage patient data obtained during clinical trials. Several EDC systems are now delivered via the Software-as-a-Service (SaaS) business model and accessed via the Internet by sites and sponsors.

EDC tools in clinical trials enable a sponsor to produce customized electronic case report forms (eCRFs) that may be filled by the researchers conducting the study. Data managers can arrange and implement electronic data capture systems to check user inputs, ensuring that any data obtained is both correct and comprehensive.

EDC software allows clinical research managers to export data to external tools for analysis once it has been gathered.

EDC Vs eCRF - what’s the difference?

When addressing digital data management for clinical trials, the phrases EDC and eCRF come up frequently, so it's crucial to define each one and understand how they vary.

An Electronic Data Capture (EDC) System is a software application that aids in the process of collecting, storing, and securing data from clinical studies, whereas an electronic Case Report Form (eCRF) is a digital version of a Case Report Form (CRF) used by researchers to record data from patients participating in a clinical trial.

In other words, "eCRF" refers to the digital forms that researchers would fill out while utilizing EDC software for a clinical trial, but "EDC" refers to the software itself.

What kind of data can you collect in an EDC system for clinical trials?

EDC systems are data capture tools in healthcare, designed to collect and organize data from clinical trials/studies, such as eCRF documentation and readings from medical equipment and other instruments.

An eCRF may contain the following information:
Patient characteristics and demographic data,
Clinical research location and patient's treatment group,
Patient health status, history, and vital sign measures,
Treatment effects/use
Patient lab reports and test results,
Patient-attached medical device readings (e.g. blood pressure, heart rate, oxygen saturation, blood glucose level, etc.)

A clinical study's goal is to collect data on factors that are relevant to the research hypothesis. A clinical trial is used by firms to assess the safety and efficacy of a medication in treating a specific illness or condition in people.

Because each clinical trial is unique, data-gathering procedures varied greatly between studies. The use of electronic data capture tools in clinical trials is used to create customized eCRF forms to guarantee that researchers gather the essential data in accordance with the specified study hypothesis and data collection strategy.

6 Advantages of using EDC software

In 2023, the most efficient sponsors and CROs will use EDC software to collect, store, and safeguard the data gathered during clinical trials. We highlight six primary benefits of EDC software and why it makes sense to abandon paper-based data collecting in the following sections.

1. Streamlined data collection process
Employing a software-based EDC system for clinical trials simplifies data collection throughout the medical device lifecycle.

Physical CRFs must be completed by researchers, sent to the study sponsor, and transferred by data entry teams into a computer database before analysis can take place in traditional paper-based data collecting. Employing EDC software for clinical data collecting avoids this time-consuming process by allowing researchers to produce data in a digital format using an eCRF.

EDC also simplifies data gathering in clinical trials by facilitating the automated transfer of clinical data from PRO equipment and medical devices.

2. Improved data quality
Another advantage of using an EDC system for data collecting in clinical trials is improved data quality.

Clinical research managers reduce the probability of data input and transcription mistakes, which occur at a greater rate in the complex paper-based data collecting method, by simplifying the data collection process.

To guarantee that data inputs are accurate and appropriately structured before they reach the trial database, EDC systems can additionally include software-based processes for increasing data quality, such as edit checks, numerical data validation, and remote monitoring.

These EDC system characteristics allow researchers to resolve data input errors and inconsistencies before they affect the study's findings.

3. Enhanced data authenticity and security

Capturing clinical trial data in an EDC system is an excellent technique to secure the data's confidentiality, validity, and dependability.

Whereas paper-based CRFs are readily lost, stolen, or destroyed - either on-site or in transit - eCRFs produced in a software EDC system are instantly uploaded to secure cloud storage, where data loss is eliminated. EDC systems can additionally include security measures like role-based access controls (RBAC), multi-factor authentication, and others to guarantee that only authorized people have access to the data.

4. More accessible clinical data

Another benefit of storing clinical data in an EDC system is that the information is more easily accessible. After researchers have completed an eCRF and saved it in your EDC system, anybody with the right authorization can view it immediately from anywhere in the world with an Internet connection.

Instead of having to wait for a box of paper CRF forms to come in the mail, data reviewers may begin evaluating and analyzing eCRF data immediately after it is prepared. With near real-time data access, clinical trial administrators may notice trends and make well-informed judgments.

5. Accelerated completion of clinical studies

The most time-consuming procedures in analyzing clinical data from paper-based CRF forms include transcribing, cleaning, preparing, and converting the data, and creating the database structure prior to analysis.

Using eCRFs EDC tools in clinical trials to enter data directly into an EDC system standardizes the data entry process and eliminates the need to invest significant time and effort in data transcription and preparation after the data has already been gathered. As a result, clinical data gathered through EDC software may be examined significantly sooner after researchers collect it.

6. Reduced clinical operations costs

Using an EDC system to collect data lowers the total cost of conducting clinical trials. EDC systems lower the overall cost of data gathering and analysis required to complete research by expediting the data collecting process, utilizing automation to ensure high-quality data, and eliminating the need for data cleaning and preparation.

In Summation
Octalsoft's EDC system enables seamless collaboration among clinical investigators/site personnel, CRAs, data managers, and any additional consultants necessary, such as central labs or central radiologists.

Octalsoft's EDC enables easy and automated collaboration between various stakeholders, with worldwide connectivity, real-time recruitment progress tracking, and subject statuses on the EDC dashboard, hierarchical workflows for data entry, verification, and validation, real-time automated edit checks, insights into data queries and resolution on a very user-friendly interface.

Join us in shaping the future of clinical research with Octalsoft's EDC! Click here to Book a Demo Now.