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The purpose of a clinical investigation (or clinical study) is to determine the safety and effectiveness of a novel treatment, such as a medical device. Biostatisticians make determinations about the results of a clinical investigation by analyzing data from Case Report Forms (CRFs) completed by investigators for each patient during the investigation.
In the past, CRFs from a clinical study would be completed on paper, packed into boxes, and shipped from the study location to a secondary location for analysis. But today, a growing number of medical device companies are going paperless and using web-based Electronic Data Capture (EDC) Systems to collect, store, and manage clinical data.
Software-based EDC systems give clinical study managers the ability to streamline the data collection process, capture more accurate data, and enhance data security and accessibility - all while saving time and reducing the cost of completing a clinical study.
In this blog, we’re breaking down everything you need to know about EDC Systems and the transition from paper-based to digital CRF record-keeping for medical device clinical studies.
An Electronic Data Capture (EDC) system for clinical trials or studies is a software solution that makes it easier for medical device companies to digitally collect, store, and manage the patient data collected. Nowadays, many clinical EDC systems are distributed in the Software-as-a-Service (SaaS) business model and accessed by sites and sponsors over the Internet.
Clinical EDC systems allow the sponsor of a clinical study to create customized electronic case report forms (eCRFs) that can be completed by the researchers performing the study. Clinical Electronic data capture systems can be configured and programmed by data managers to validate user inputs, ensuring that any data collected is both accurate and complete.
After sufficient data has been collected, clinical EDC software allows clinical study managers to export the data to external tools for analysis.
“Direct data capture” (DDC) is the process of entering data on the spot into an electronic tool. For example, one can input data directly into an eCRF. To know how to make better decisions that will inform your design and implementation of an eCRF, check out our “10 best practices for eCRF in Medical Device Trials.”
In Greenlight Guru Clinical’s electronic data capture (EDC) software, medical device manufacturers can enter clinical data contemporaneously (during visits) or at a later point in time. Designed to fit MedTech needs, you don’t need technical skills to get started. Our ready-to-use templates, modules, and features will help you to easily design the optimal clinical study.
Greenlight Guru Clinical’s EDC software allows clinicians to collect patient reported outcomes electronically on any device, thanks to bring-your-own-device (BYOD) capabilities. Our clients make full use of the Greenlight Guru Clinical ePRO capabilities by tailoring it to their clinical study needs. It can fulfill your post-market requirements as well as product and market research.
We're taking a moment here to define what eSource is, in the context of collecting and managing clinical trial data. eSource is a term that you might have encountered in the clinical trial space. Several online sources portray eSource as a modern solution, outweighing electronic data capture.
EDC systems of today however include the real-time capabilities of eSource. While there used to be differences between when and what data an electronic data capture system collects, nowadays there is no clear divide.
By definition, eSource (electronic Source) collects data at the source. Examples of source data can be visit-based data inputs (e.g. blood pressure, concomitant medication, weight etc.) That is also what most electronic data capture systems can do nowadays. One can say, EDC systems are a type of eSource.
Greenlight Guru Clinical is a modern EDC system made for medical devices & diagnostics that is able to collect and store both clinical and compliance data. It can be used as a hybrid solution, to collect data during visits, or input data at a later time. One of the greatest advantages of SMART-TRIAL EDC compared to others on the market, is that it considers the needs and workflow of clinical teams.
The terms EDC and eCRF come up often when we’re discussing digital clinical trial data management for medical devices, so it’s important to define each one and understand how they’re different.
An Electronic Data Capture (EDC) System is a software application that helps streamline the process of collecting, storing, and securing data from clinical studies, while an electronic Case Report Form (eCRF) is the digital version of a Case Report Form (CRF) used by researchers to record data from about patients participating in a clinical trial.
Stated differently, the term “eCRF” refers to the digital forms that researchers will complete when using EDC software for a clinical trial, while the term “EDC” refers to the software itself.
Clinical EDC systems are purpose-built to collect and organize data from clinical trials/studies, including eCRF documents and readings from medical devices and other instruments.
An eCRF can include information such as:
Patient characteristics and demographic data,
Clinical study site and patient’s treatment group,
Patient health status, history, and vital sign measurements,
Patient lab reports and test results,
Readings from patient-attached medical devices (e.g. blood pressure, heart rate, oxygen saturation, blood glucose level, etc.)
The purpose of a clinical study is to gather data regarding variables that are relevant to the research hypothesis. For medical device companies, the purpose of a clinical study is to evaluate the safety and efficacy of a medical device for treating a specified disease or condition in patients.
Because each clinical study is different, data collection practices vary significantly between clinical studies. EDC systems allow clinical trial sponsors to design customized eCRF forms to ensure that researchers collect the necessary data as per the stated research hypothesis and data collection plan.
For clinical studies following a paper-based data collection strategy, there’s only one real option for data collection: researchers complete paper CRFs, store them, then box and ship them to clinical trial sponsors where biostatisticians will analyze the results.
To better understand how electronic data capture fits into the clinical study workflow, let’s look at three methods researchers use to input data into clinical EDC software:
The first option for EDC data collection is direct data entry. Researchers can login to the EDC software using secure access credentials, open the relevant eCRF for the study, and enter clinical data into the system where it immediately becomes available for data reviewers and other stakeholders.
Researchers can also choose to complete CRF forms the traditional way, using paper, then transcribe those paper CRFs into the EDC system at a later time.
Having said that, we do not recommend simply copying the paper-based CRF to an electronic CRF inside an EDC system for a number of reasons. The most important being, previous challenges encountered on paper, will be transferred to the electronic format.
Check out or free eBook ''7 Principles to Designing an eCRF'' to learn best practices to designing an eCRF to reduce costs and save time.
Transcription-based data collection may also take place when data from patient-reported outcomes (PRO) or electronic health records (EHR) is entered into the EDC system.
An important advantage of using electronic data capture (EDC) instead of paper-based data collection is the ability to capture data via automatic transmission. Modern EDC systems can receive data transmissions from ePRO instruments (which are sometimes a part of the EDC software system), and connected medical devices (DHT)s, automating those portions of the data collection process.
Adverse Events Reporting Modules
Connected devices and wearables integration
Integration options via application programming interfaces (APIs)
The most efficient medical device companies in 2023 are using EDC software to collect, store, and secure the data they collect in clinical investigations. Below, we summarize six major advantages of EDC software and why it makes sense to move away from paper-based data collection.
Using a software-based EDC system for clinical trials helps streamline the data collection process throughout the medical device lifecycle.
With traditional paper-based data collection, physical CRFs must be completed by researchers, shipped to the study sponsor, and transferred by data entry teams into a computer database before analysis can occur. Using EDC software for clinical data collection bypasses this lengthy process by empowering researchers to create the data in a digital format with an eCRF.
EDC in clinical trials also streamlines data collection by enabling the automatic transmission of clinical data from PRO instruments and medical devices.
Improved data quality is another advantage of deploying an EDC system for data collection in clinical trials.
By streamlining the data collection process, clinical study managers cut down on the possibility for errors in data entry and transcription that occur at higher rates in the convoluted paper-based data collection process.
EDC systems can also incorporate software-based mechanisms for improving data quality, including edit checks, numerical data validation, and remote monitoring, to ensure that data inputs are accurate and correctly formatted before they reach the trial database.
These EDC system features give researchers the opportunity to correct data entry mistakes and discrepancies before they can influence the outcome of the study.
Collecting clinical trial data in an EDC system is a great way to ensure the security, authenticity, and reliability of the data.
While paper-based CRFs can easily be lost, stolen, or damaged - either on-site or in transit, the eCRFs created in a software EDC system are immediately uploaded to secure cloud storage where there’s zero risk of data loss. EDC systems can also incorporate security features, such as role-based access controls (RBAC), multi-factor authentication, and more, to ensure that only authorized persons may access the data.
Another advantage of recording clinical data in an EDC system is that the data is more accessible. Once an eCRF has been completed by researchers and saved in your EDC system, it can be accessed immediately from anywhere in the world with an Internet connection by anyone with the appropriate authorization.
Instead of waiting for a box of paper CRF forms to arrive by mail, data reviewers can start reviewing and analyzing eCRF data just moments after it has been created. With near real-time access to data, it becomes easier for clinical trial managers to detect trends and make well-informed decisions.
When it comes to analyzing clinical data from paper-based CRF forms, the most time-consuming tasks include transcribing, cleaning, preparing, and transforming the data, and defining the database structure prior to analysis.
Entering data directly into an EDC system with eCRFs standardizes the data entry process and reduces the need to invest massive time and effort in data transcription and preparation after data has already been collected. As a result, clinical data collected in EDC software can be analyzed much sooner after it is collected by researchers.
Collecting data with an EDC system reduces the overall cost of conducting clinical trials. By streamlining the data collection process, leveraging automation to ensure high-quality data, and reducing the need for data cleaning and preparation, EDC systems reduce the total cost of data collection and analysis needed to complete a study.
The ability to execute clinical studies more quickly means that medical device companies can fast-track their pathway to market authorization and start realizing profits even sooner than expected.
Greenlight Guru Clinical is the first and only data gathering and management system that’s purpose-built for medical devices and diagnostics.
With Greenlight Guru Clinical, medical device companies can create customized eCRFs and digitize data collection for clinical investigations, in-human studies, and post-market surveillance activities.
Greenlight Guru Clinical is out-of-the-box compliant with ISO 14155:2020 and includes templates for data collection planning and regulatory compliance that help medical device companies execute organized, cost-effective, and compliant studies that bring products to market faster.
Ready to Learn More? Contact us for a customized demo.
Páll Jóhannesson, M.Sc. in Medical Market Access, is the founder and Managing Director of Greenlight Guru Clinical (formerly SMART-TRIAL). Páll was previously the CEO of Greenlight Guru Clinical where he led the team to create the only EDC specifically made for medical devices.