Top Healthcare Software to Power Decentralized Trials

Because decentralized clinical trials use healthcare software to share data remotely, decentralized trials can’t succeed without the right technology. But with dozens of clinical research platforms flooding the market, it keeps getting harder to figure out what they all do and which ones you need. 

Although every platform has different features, software for clinical trials tends to fall into seven broad categories. You can use this guide to determine what category of healthcare software you’re looking for before you start researching platforms. Knowing what you need ahead of time will help you find a vendor quickly, implement your new software, and get back to running decentralized clinical trials.

1) Design Protocol Software

What it is: This software helps investigators set up the research protocol at the beginning of a clinical trial. Some design protocol programs even come with AI to advise investigators about how to best manage participants and data. 

Who might need it: Principal investigators and other researchers who design clinical trial protocols

How it helps: This software may make clinical trials run faster by saving investigators time during the protocol design stages. It can also help investigators create protocols for decentralized trials if they haven’t used a decentralized method before. 

2) Patient Recruitment Software

What it is: Patient recruitment software helps patients search for clinical trials they may be eligible for and helps research staff find patients who meet the criteria for their trials. Some patient recruitment platforms work with both researchers and patients, while others focus their efforts on one or the other. Patient recruitment software may also incorporate HIPAA-compliant AI. With the patient’s permission, the AI can comb through their electronic health records to determine whether the patient meets the requirements for specific trials. 

Who might need it: Patients who are searching for trials they’re eligible for; research sites who need to meet their recruitment goals 

How it helps: With the rise of precision medicine that only works for people with specific genes and the need to make clinical trials more diverse, many research sites fall short of their recruitment goals. This healthcare software can help research sites find diverse candidates who meet precise genetic requirements and who may not ordinarily have found out about clinical trials. 

3) Patient Engagement Software

What it is: Many software platforms handle both patient recruitment and patient engagement. However, some software is only designed for one or the other. Patient engagement isn’t just about getting patients to enroll in the trial—it’s also about making sure patients keep participating in the trial once they’re enrolled. Patient engagement and retention platforms can remind participants to take their medication, wear their devices, or fill out their patient diaries. 

Who might need it: Research sites who want to make sure they retain patients; participants who want to understand what’s going on in their trial

How it helps: Clinical research staff can’t compile meaningful endpoints if too many patients drop out of trials or don’t follow protocols, so they need to encourage patients to stay actively engaged. This healthcare software keeps participants informed and saves researchers from repetitive, time-consuming tasks like sending reminders. 

4) Trial Start-Up Software

What it is: Trial start-up software helps research sites, sponsors, and CROs get their clinical trials up and running efficiently. This category includes training software, the electronic Investigator Site Files (eISFs) typically used by research sites, and the electronic Trial Master Files (eTMFs) used by coordinating centers, CROs, and sponsors. It may also include the software used to create electronic informed consent forms. Many of Florence’s products, like eBinders and eTMF, fall into this category. 

Who might need it: Clinical research associates and coordinators at research sites, sponsors, and CROs 

How it helps: Getting clinical trials up and running efficiently saves research sites and sponsors money and helps new drugs get to market faster. With site start-up costs hovering around $42,700 (according to Sofpromed), it’s important to save time and money where possible. This healthcare software can help sites and sponsors spend less time getting studies set up and compiling regulatory documents. 

5) Trial Operations Software

What it is: Trial operations software helps research sites, CROs, and sponsors with the everyday tasks of running a trial, like storing data, viewing documents, and updating logs. Many start-up platforms fall into this category too: for example, Florence eBinders can handle both trial start-up and trial operations. However, this category can also include software that isn’t needed until the trial actually starts, like payment collection and monitoring programs. 

Who might need it: Clinical research and clinical operations staff at research sites, sponsors, or CROs

How it helps: Storing all clinical trial documents in one place keeps trials organized and operating efficiently. Trial operations software also makes it easy to keep track of documents, logs, and payments when you’re running multiple trials at once

6) Patient Data Management Software

What it is: Patient data management software collects lab results, clinical assessments, and digital biomarkers for clinical trial participants. Wearables, electronic data capture (EDC) software, and electronic clinical outcome assessment (eCOA) platforms all belong in this category. 

Who might need it: Clinical research and clinical operations staff at research sites, sponsors, or CROs

How it helps: Decentralized clinical trials only work if patients can send data when they’re not at the research site. Patient data management software collects information from wearable devices or local physicians’ offices and sends it straight to the site so investigators don’t have to worry about data going missing or being transmitted incorrectly. Data can also be transmitted to sponsors and CROs quickly and accurately. 

7) Decentralized Clinical Trial Software 

What it is: All of the software on this list can be used during a decentralized clinical trial. But when companies call their product “decentralized clinical trial software,” they usually mean that it is meant for fully remote trials only. These apps and online programs connect investigators to patients without patients ever visiting the research site. 

Who might need it: Sponsors, CROs, or research sites who want to run fully remote trials; patients looking for fully remote trials they can participate in

How it helps: These apps can reach patients who aren’t willing or able to visit research sites and draw more patients into clinical trials, as long as those patients have WiFi and a device. 

Bringing Different Types of Healthcare Software Together

Although these categories can help you navigate the world of clinical research software, no list can fully encompass the nuances of each program. Some software can help with trial start-up, patient data management, and daily operations, while other software focuses solely on patient recruitment or on collecting payments. 

It’s also important to remember that just because software can perform many functions doesn’t mean it’s the best at all of those functions.

Most researchers will want to cut down on the number of individual programs they use, since clinical trial staff are too busy to learn half a dozen new platforms. At the same time, you don’t want to choose multi-functional software only to discover that many of those functions are slow, clunky, or ineffective. 

How Integrations and Single Sign-On Can Help

Integrations and Single Sign-on (SSO) can bring together different forms of software. SSO lets you use multiple programs without logging into them separately, so you only have to remember one username and password. Integrations transfer data between two platforms.

When you combine SSO and integrations, you can log on once to see all of your data in a single place. 

Whether clinical trial software can accommodate integrations depends on whether the software has an open API. Some vendors create “closed systems” that can only integrate with other software from the same vendor. Clinical trial software with an open API, however, can integrate with programs from other vendors as long as those vendors also use open APIs. 

You can get more details about open APIs here, but the basic idea is simple: you need to pick software with an open API if you want to integrate that software with programs from other vendors.

Choosing the Right Software for Your Team

Whether you work for a research site, a sponsor, or a CRO, you need to find software programs that power your decentralized clinical trials without burying you under a pile of technology. 

The first step is to decide which categories of software you need. Then, you can talk to vendors about all of the features their software has, whether the software fits into multiple categories, and if it can integrate with other programs. 

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