Site, Sponsor, and Mobile Technologies in Clinical Trials: The Technology Landscape

More than 250 companies create site, sponsor, and mobile technologies for clinical trials. Choosing between that many platforms can be overwhelming, especially when the average clinical research team already logs into six software platforms for every study. 

Yet technology also has tremendous potential. Platforms like Electronic Data Capture (EDC) electronic Investigator Site File (eISF), and electronic consent (eConsent) software can remove routine busywork, connect sites and sponsors, protect data quality, and accelerate trials. 

So how do you figure out what technology will help your team, and which technology will only lead to frustration? 

Andrea Bastek, PhD and Beau Bruneau hosted a summit with clinical research professionals to discuss what types of technology exist, who should own them, and how to decide which software is right for which team. 

Keep reading to find out more about clinical research tech, and check out our 2023 State of Clinical Trial Technology Report to discover how 450 other teams use software.

Types of Clinical Trial Technology

At Florence’s virtual clinical research summit, the attendees talked about five kinds of clinical research software: 

  1. Regulatory
  2. Operations
  3. Investigational Product (IP) administration
  4. Clinical protocol execution
  5. Data collection

These aren’t the only categories clinical trial software can be sorted into, but they offer a helpful starting place.

1. Regulatory

Regulatory software consists of platforms like: 

These platforms focus on helping sites, sponsors, and CROs maintain their regulatory documentation. Regulatory software is already popular: 

Unfortunately, eISFs and eTMFs are often disconnected. Sites have to complete their documents in an eISF, then upload them to an eTMF. Better integrations between eTMFs and eISFs could lead to less repetitive busywork for sites.

2. Operations

When clinical research teams talk about operations software, they mean platforms that help with the day-to-day management of clinical trials. Examples might include: 

Operational software can overlap with regulatory software in some cases–for example, sites can use an eISF or eReg platform both to store regulatory documentation and to manage data during a trial. 

One software platform can also fit into multiple categories. Florence’s SiteLink™ includes an eISF/eReg platform for research sites, as well as feasibility features and remote site access for sponsors. Florence refers to these integrated, site-sponsor collaboration platforms as Site Enablement Platforms.

3. Investigational Product administration

The Investigational Product is the drug or device tested in a clinical trial. Software used for Investigational Product administration might include: 

  • Randomization software (to determine which patients receive a treatment or a placebo) 
  • Trial supply management software (to track the shipping and arrival of IPs) 

IP administration software tends to be highly specialized and doesn’t overlap with other categories as often as Regulatory and Operations software do.

4. Clinical Protocol Execution

Clinical Protocol Execution is a broad category for software that helps sites, sponsors, and CROs carry out their protocols. This category also includes a few patient-facing and mobile technologies in clinical trials. 

Technology for patient engagement includes: 

  • Electronic informed consent (eConsent) 
  • Patient payment software
  • Telehealth

Other Clinical Protocol Execution technology doesn’t involve patient interaction. These platforms could include: 

  • Patient recruitment or patient matching software 
  • Protocol helper software (for quickly referencing protocols) 

Patient recruitment is one of the fastest-growing technology categories, with dozens of vendors. Sponsors ranked patient recruitment as the number-one problem they wanted to solve through tech in our 2023 State of Clinical Trial Technology survey, so this category will likely continue to grow.

5. Data

This category includes any software used to collect data during the clinical trial process. Software platforms in this category are: 

  • Electronic source data (eSource) 
  • Electronic Clinical Outcome Assessment (eCOA) 
  • Electronic Patient-Reported Outcome (ePRO) 
  • Wearables/sensors
  • Electronic Health Record/Electronic Medical Record (EHR/EMR) 
  • Electronic Data Capture (EDC)
  • Clinical Data Analysis

eSource and other forms of data-based technology have become common, with 72% of sponsors deploying eSource to research sites in 2023. 

The data category also contains many patient-facing and mobile technologies. ePRO software and wearables, in particular, are often used to let patients submit data from home. 

So with all of this technology, who should own what–and how do you know which technology you need? Here are three key considerations to help your team make technology decisions.

Key Takeaways about the Clinical Research Technology Landscape 

Even with a categorization system for their technology, clinical research teams are still left with hundreds of platforms to choose from. So how do you make sense of what clinical research software your team needs? 

At our virtual clinical research summit, we heard three guiding principles from research teams: 

  1. The team who uses tech is often not the team who purchases it: we need to emphasize ease-of use for the end user. 
  2. Sites and sponsors both want the other to accept their technology. Collaboration is key. 
  3. It’s not enough for technology to be available–it needs to solve the specific challenges clinical research teams face. 

These principles can help sites, sponsors, and CROs choose the right technology for their teams.

1. The team who uses tech is often not the team who purchases it:  ease-of-use for the end user is critical. 

Sponsors or CROs often purchase technology for sites to use. 67% of sites receive ePRO software from their sponsors, 59% receive eCOA software, and 37% receive eConsent software. About a quarter (28%) receive an eISF or site feasibility software.

Sponsors giving technology to sites can be helpful–if sponsors understand sites’ workflows and provide technology that’s easy for them to use. Florence advocates for Site Enablement software, site-centric platforms for collaboration between sites, sponsors, and CROs.

How can sponsors and CROs determine whether a platform will enable sites? Strategies include:

  • Involving site users in choosing technology
  • Searching for vendors with high site adoption rates
  • Ensuring sites control who has access to their documents and data

With these strategies, clinical research teams can find software that works for the user, not only the purchaser.

2. Sites and sponsors both want the other to accept their technology. Collaboration is key. 

When asked how they would like sponsors to approach technology, the majority of sites chose “Accepts site-owned technology” as their number-one priority. 

But sponsors also said their number-one priority for sites was “Accepts sponsor/CRO-provided technology.” What’s the solution to this site-sponsor conflict? 

Integrations are one option. If a site’s preferred platform and a sponsor or CRO’s preferred platform are integrated, each team can use the platforms they prefer, and collaboration becomes easier. 

Many vendors also make more than one product: for example, they might make an eISF and an eTMF, or an EDC and eConsent platform. But with hundreds of styles of clinical trial software, it’s doubtful one vendor could make a great version of them all. Integrations let sites and sponsors pick the best version of each platform and still collaborate.

3. Technology needs to address clinical research’s specific problems. 

Technology should help clinical trial teams, not overwhelm them. But clinical research teams still face many challenges that technology platforms haven’t been able to solve. 

For example, dozens of platforms now exist to help with patient recruitment. But recruitment remains sponsors’ number-one problem they’d like to solve with technology, and 80% of sites don’t meet their recruitment goals on time. 

That means it’s time, not to build more technology, but to listen to what sites and sponsors need from their technology. Should recruitment technology target patients using different tactics? Are there demographics that are underserved? Is better patient matching needed for precision medicine trials? 

Just because technology exists doesn’t mean it meets teams’ needs. Technology vendors need to commit to listening to clinical research professionals–and clinical trial teams need to seek out vendors who will accept and incorporate their feedback.

Moving Forward with Site, Sponsor, and Mobile Technologies

Clinical research teams have to choose between hundreds of clinical trial software platforms, and it’s easy to get overwhelmed. To find technology that will accelerate trials instead of slowing them down, research professionals need integrated, easy-to-use platforms that focus on enabling all stakeholders–sites, sponsors, CROs, and patients. 

To hear what other sponsors, CROs, and sites seek out in their technology, read our 2023 State of Clinical Trial Technology Report, with insights from 450 clinical research teams on the future of the technology landscape. And if you missed the chance to attend the Innovation Summit, you can find the full recording here.