10 Tips for Selecting the Right EDC Software for Clinical Investigations

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.

FREE RESOURCE: Click here to download our 15-in-1 clinical investigations content bundle to help you run studies and collect clinical data more efficiently.

What is EDC Software?

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.

10 Tips for Selecting the Right EDC Software for MedTech Clinical Trials

1. Choose a Purpose-built EDC for Your Research Category

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.

Ask Vendors This:

• 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?

2. Pick an EDC with Features that Fit Your Study Protocol

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.

Ask Vendors This:

• How will your solution support our clinical data collection workflow?

• How is data processed before, during, and after my study?

3. Select an EDC with Support for Device AE/SAE 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. Greenlight Guru's EDC platform (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.

Ask Vendors This:

• Does your EDC software offer ISO 14155:2020 compliant safety reporting?

• What is the workflow for documenting device deficiencies and SADEs?

4. Find a Pre-validated Solution as per MedTech Regulatory Requirements

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.

Ask Vendors This:

• 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?

5. Choose an EDC that Supports MedTech Compliance Needs

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.

Ask Vendors This:

• 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.?

6. Customer Support with MedTech Experience and Know-How

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.

Ask Vendors This:

• 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?

7. Choose an EDC Software that Facilitates Collaboration

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.

Ask Vendors This:

• 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?

8. Do a Value Comparison

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.

Ask Vendors This:

• 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?

9. Verify Data Export Capabilities

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.

Ask Vendors This:

• Which statistical tools does your product support?

• What data export formats are supported?

10. Focus on Usability

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.

Ask Vendors This:

• 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?

FREE RESOURCE: Click here to download our 15-in-1 clinical investigations content bundle to help you run studies and collect clinical data more efficiently.

5 EDC platforms worth shortlisting for CROs and small biotechs

Everything above applies whether you are a five-person device startup running your first feasibility study or a CRO setting up the fortieth study of the year. But the two buyers weigh the tips differently. A CRO cares most about tip #2 (features that fit variable protocols across sponsors) and tip #8 (value, since setup hours eat into margin on every study). A small biotech cares most about tip #4 (pre-validated) and tip #10 (usability, since there is no dedicated data manager on staff). Here is how five platforms commonly on these shortlists compare against those specific tips.

1. Greenlight Guru Clinical EDC

Purpose-built for medical device and diagnostics investigations, which answers tip #1 directly. Validation documentation ships with the platform (tip #4), so a small biotech is not left assembling that evidence on its own, and a CRO can put it straight into a bid. eCRF templates and study configurations carry forward between studies, which is the tip #2 answer a CRO needs when every new sponsor arrives with a different protocol. Sponsors keep unconditional access to their own data with no export fee, and pre-market studies, PMCF surveys, and registries all run from the same platform, so a small biotech does not face a migration when its first study moves from feasibility into post-market follow-up.

The onboarding speed shows up in customer accounts rather than just marketing copy. Loop Medical, a Class II device company that had been managing international studies on paper, set up a new study in a couple of weeks without anyone working on it full time. Kerecis moved its compliant studies off Excel and reached full data compliance across both the US and Europe. InnoCon Medical's clinical project manager put the site side of it plainly: the platform is simple for sites to use, which matters directly for tip #10 when a study has no dedicated data manager watching over site staff.

2. Castor

New organizations report needing one to three hours of training before starting a study, which is a strong answer to tip #10 for a team with no dedicated clinical operations staff. Castor markets support for medical device work including MDR and PMCF studies, and it is 21 CFR Part 11, HIPAA, and ISO 27001 compliant. Confirm directly with the vendor whether device-specific safety taxonomy and validation documentation ship as standard or get configured per study, since that detail is not published.

3. Medrio

Site-centric workflows and a no-code form builder suit smaller sponsors who need real functionality without enterprise complexity, and offline capture is useful for CROs running sites with unreliable connectivity. Device work is not the platform's stated focus, so ask specifically what tip #5's compliance questions turn up regarding ISO 14155 rather than assuming Part 11 coverage extends that far.

4. ClinCapture

A modern cloud platform built for digital-first research from the start rather than adapted from paper workflows, with decentralized and hybrid study support. Device-specific configuration is possible but not the design center, so tip #4's validation question is one to put in writing before a study starts, not after.

5. OpenClinica

The open-source option, and the right one to evaluate when a CRO or biotech has real in-house technical capability and wants control over hosting. More than 15,000 studies and three million patients on the platform by the company's own count. The trade-off against tip #4: the sponsor or CRO owns the validation evidence rather than receiving it, which is a meaningful amount of work for a team without a dedicated function for it.

None of these five platforms are being ranked against each other here. Which one fits depends on which tips above matter most for the specific study and the specific team running it.

Greenlight Guru Clinical EDC Software Is Purpose-fit for MedTech Clinical Studies

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.