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Using Electronic Data Capture (EDC) software can save you time and money in the data collection process for your medical device clinical investigation - but how do you determine which one to choose?
In this blog post, we’re sharing 10 of our best tips for selecting the right EDC software for clinical studies in MedTech. We’ll also share some of the tough questions you can ask vendors to better navigate the EDC selection process.
EDC software allows researchers to collect, store, and manage clinical data using electronic case report forms (eCRF) instead of traditional paper-based report forms (CRF).
By going paperless, clinical study sponsors can streamline the data collection process, increase data accessibility and security, and reduce the cost and complexity of running clinical investigations.
But not all EDC software tools are created equal, and it’s important for clinical trial sponsors to choose carefully when placing their trust in any data collection solution. Here’s what to look for during the selection process, along with some questions you can ask vendors to better understand their offerings.
Clinical research can be divided into many distinct categories. There are clinical trials on medical devices, trials on medicinal products like vaccines and pharmaceuticals, and trials on other types of therapeutics (e.g. radiotherapy, surgery, transplantation). We also see physiology and psychology trials, nutritional and diagnostic studies, and epidemiological studies in clinical research.
Whatever your innovation, we recommend choosing an EDC solution that’s purpose-built for your research category. If you’re a medical device company, an EDC solution that’s purpose-built for medical device trials is most likely to suit your needs out-of-the-box with minimal customization.
Is your product purpose-built for medical device trials?
Do you offer ready-to-use templates for MedTech studies?
Do you provide template forms for eCRF or study building in general?
Your clinical study protocol is a document that describes how your study will be conducted, including the objectives, study design, methods, data collection plan, and general organization.
We recommend that medical device companies document a clinical investigational protocol before selecting an EDC system. The idea is to choose an EDC solution with capabilities that fit your study protocol and data collection plan, and to avoid the trap of designing your study protocol to fit the capabilities of a pre-selected EDC solution.
MedTech studies require complex clinical workflows to be aligned with the data collection plan. This can place a big strain on the EDC platform if it is not designed to support device study workflows. This can include e.g. repeated uses or treatments with the device, multi-protocol support (to enable data collection across different indications), or adverse event and device deficiency reporting.
How will your solution support our clinical data collection workflow?
How is data processed before, during, and after my study?
To comply with GCP in medical device clinical trials, investigators need to track and report on device deficiency events that may have resulted in a serious adverse device effect (SADE). An easy way to achieve compliance is to choose an EDC solution that supports adverse event reporting. Greenlight Guru Clinical (formerly known as SMART-TRIAL) delivers an AE reporting module that streamlines GCP compliance by making it easy for researchers to create DD SADE reports and link them to eCRF.
Does your EDC software offer ISO 14155:2020 compliant safety reporting?
What is the workflow for documenting device deficiencies and SADEs?
Software validation is a form of software quality control that checks whether an EDC solution meets the required specifications to be used for its intended purpose.
Medical device regulators require medical device companies to properly validate any computerized systems used in clinical data collection to ensure quality data collection and compliance with the applicable legal requirements. Choosing a pre-validated EDC solution means that medical device companies can move ahead with confidence and focus on executing a high-quality study instead of validating software tools.
Is your EDC software fully validated to ensure it functions as advertised?
How much work is required from the Sponsor, in terms of software validation?
Depending on where your company is located and where you intend to sell or market products, you may need to conduct clinical investigations in compliance with ISO 14155:2020 or ISO 20916 and the country specific requirements, such as FDA’s 21 CFR Part 11, or EU MDR/IVDR.
To avoid any unforeseen regulatory challenges, it’s important to choose an EDC software system that supports the specific compliance needs of your clinical investigation.
Is your tool able to document compliance and validation according to ISO14155:2020, ISO20916? Do you get audited on these requirements every year?
Does your EDC system facilitate compliance out-of-the-box with ICH GCP, FDA 21 CFR Part 11, GDPR, etc.?
We recommend choosing an EDC vendor with exceptional customer support in their services, and also understands the MedTech industry. A responsive vendor can provide much-needed expertise to help you avoid pitfalls and make the most of your investment in EDC software.
By having access to a customer support team that understands the MedTech industry terms and regulatory requirements ensures efficient service and support. Being able to rely on past experiences with other companies in a similar situation is invaluable.
What are your standards or SLAs for providing customer support? Is it included in your service?
How will you help us succeed with your EDC software?
What is your experience with MedTech regulations and requirements?
An EDC software can enable collaboration by supporting simultaneous data access for multiple users while accurately enforcing user permission controls that protect patient privacy. Real-time collaboration improves the efficiency of your study, helps resolve queries faster, and breaks down operational silos between researchers, sponsors, investigators, and downstream data analysts.
At the same time, collaboration also ensures that study setup can be completed efficiently. Teams can collaborate on building and testing a study, using various roles and features to plan data entry thoroughly.
How does your EDC system support collaboration between study stakeholders? During building and production.
What controls do you offer that can help us protect data privacy during collaboration?
Most shoppers think about doing a price comparison between two items, but we always recommend doing a value comparison instead. That means looking beyond the sticker price to understand the features you’re getting from each solution and the potential impact to your bottom line. It also means comparing features between products to understand what’s included with your EDC solution - and what’s not.
What features, capabilities and services are included with my software subscription/license?
What does my subscription NOT include?
Who is your biggest competitor and why should we choose you instead?
One thing you should always do before committing to an EDC software solution is to verify that it can export data in your preferred format and integrate with your downstream data analytics tools. If your EDC can’t export to your data analytics solution, you’ll need to switch to another tool or waste valuable time searching for a workaround.
Which statistical tools does your product support?
What data export formats are supported?
The concept of usability in software design refers to how easily users can interact with the software and navigate user interfaces to achieve their goals.
Your EDC software will be accessed and used by a variety of stakeholders, including clinical study sponsors, monitors, researchers, participants, and downstream data analysts. The easier it is for all of these users to accomplish their goals, the more time and money (and frustration) you’ll save with your EDC software.
Have you conducted usability studies of your EDC software? What were the results?
Do you have any customer references that I can ask about usability?
Greenlight Guru Clinical is an EDC software solution that’s purpose-built to support the electronic data collection, storage, and management requirements of medical device clinical investigations.
Our EDC software delivers out-of-box compliance with ISO 14155:2020, easy-to-use templates for building customized eCRF, a streamlined approach to AE reporting, GDPR-compliant data export, and support for many different protocol designs.
With Greenlight Guru Clinical EDC software, medical device companies benefit from a user-friendly and pre-validated solution that can increase the efficiency and reduce the cost of clinical studies.
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.