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.
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. 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.
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. 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.
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.
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.
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.
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.
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.
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.
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.
SMART-TRIAL 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 SMART-TRIAL EDC, medical device companies benefit from a user-friendly and pre-validated solution that can increase the efficiency and reduce the cost of clinical studies.
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