Before a research site can take advantage of new technology platforms, it must first ensure it has a solid foundation from which to build.

Research sites that have not prepared for the coming wave of technology advancements will find themselves lagging behind their peers – and potentially locked out of participating in the clinical trials of tomorrow. Especially in light of COVID-19 that has resurfaced important conversations surrounding real-time and remote access to the information (data and documents) maintained at the research site.

Prior to the disruption to clinical research continuity, our Annual State of the Industry Survey of clinical research sites revealed four significant technologies that are important to leadership teams. While there are countless technology platforms to be considered, these are the four that emerged as essential for preparing your organization for technology transformation.

In this article we will discuss the three main ways to prepare your Research Site for technology transformation, reveal the top four technologies most research sites are already using or preparing to use in the near future, and discuss the technology adoption curve to determine where your site falls in adoption of innovation.

If you are interested in viewing the entire 2020 Clinical Research State of the Industry report, which includes more information on how technology is impacting clinical research, please download the full report here.

Three Key Elements to Prepare your Site for Technology

As you begin to consider technology for your site, it is important to begin preparing your organization for the changes to come. This preparation will ensure a smooth transition from your current operational processes to those that take place in an electronic platform.

At Florence, we have implemented hundreds of research teams and currently have over 7,200 research teams active in our technology platform. From this experience, we’ve found that there are three key elements required for a clinical research site to prepare for technology change.

Get out of Paper

For clinical trial organizations to take advantage of any of the future technology innovations, they must first be entirely out of paper.

It is impossible to participate in the clinical trial of tomorrow – including virtual trials, remote monitoring, real-time data exchange, and real-world evidence – when a site is maintaining its records in either a paper file or a generic, disconnected, document management tool.

A majority of research sites have already made this shift, with 61% planning to be on an eRegulatory platform before the end of 2020. However, for the remainder, it is vital to future operations that a transition to eRegulatory be an essential element of your 2020 strategic roadmap.

As you explore your options, it’s vital you invest in a best-in-class eRegulatory vendor that will in turn, invest in you. Build your list of all required or must-have eReg features and think-through those features that are important to needs specific to your organization, so you are better prepared to evaluate potential eReg options. We built a eRegulatory capability checklist to help get you started.

Take the time to understand the nuances of your current workflows and processes to be able to explore eReg options that allow you to maximize those – instead of changing your operations to meet a platform’s limitations.

Ensure System Integrations

The ability to integrate all of your clinical trial software platforms is essential for taking advantage of the coming wave of technology as well as the essential platforms for operations today.

Without open integrations, “one-size-fits-all” platforms will lock you into systems that do not allow you to take advantage of best-in-class software solutions – or invest in new future technologies as they emerge.

When examining integrations, it is vital to remember that there are two stakeholder groups to consider:

  • Internal Stakeholder Groups – Integration between the various platforms your team uses, such as the CTMS, eReg, and EMR, is vital for streamlining collaboration.
  • External Stakeholder Groups – As the industry moves towards a connected ecosystem, it is crucial that you verify that your internal systems can integrate with external systems – such as IRB Portals and Sponsor eTMF platforms.

Be sure to talk with any prospective software vendor about their ability to integrate with other systems. Your software vendor must assume a posture of an Open API – meaning they allow other solutions to integrate with their tools. This Open API will enable you to take advantage of current and future best-in-class software platforms.

 To verify your vendor aligns with this, ask them:

  • Do you have an Open API?
  • Do you limit API calls?
  • Is your API clearly documented?
  • How are your APIs secured?

For more information about what to ask a vendor regarding integrations, read the Florence Guide to an Open API Article.

Prepare your Workforce

Successful adoption of technology at your research site requires an adequately prepared workforce. The skills needed to manage clinical trial operations will be vastly different in three years as technology automates and replaces numerous operational tasks.

As you prepare your workforce for this transition, Florence recommends three courses of action:

Key Technology Adoption in 2020 Among Clinical Research Sites

The most effective way of displaying technology adoption is by placing it on the technology adoption lifecycle curve. This curve indicates where a technology is in its maturity, and how highly you should be prioritizing it to remain relevant.

Innovators are risk-takers who have the resources and desire to try new things, even if they fail.

Early adopters are selective about which technologies they start using. They are considered the “one to check in with” for new information.

Early majority take their time before adopting a new idea; they are willing to embrace new technology as long as they understand how it fits.

Late majority adopt in reaction to peer pressure, emerging norms, or economic necessity.

Laggards are traditional and make decisions based on past experiences. Laggards run the risk of becoming impossible to do business with as they maintain antiquated systems and processes.

eRegulatory Adoption Lifecycle

Electronic Regulatory Platforms (eRegulatory) have seen a very fast maturity among the adoption lifecycle curve as they become essential for conducting clinical trials.

Annually Florence asks the question: “Do you have or plan to have an eRegulatory platform by the end of this year?”. The results clearly show a rapid progression among the eRegulatory lifecycle curve. This growth indicates that organizations without an eRegulatory platform by the end of 2020 run the risk of entering laggard stage in 2021.

eClinical Technology Adoption

In addition to eRegulatory at 61% adoption by the end of 2020, three other technologies emerged as clear priorities for 2020.

CTMS: At 69% planned adoption by the end of 2020, the CTMS is projected to enter the laggard stage by the beginning of 2021. If you do not have a CTMS platform it is essential to invest in this technology now.

eConsent: At 28% planned adoption by the end of 2020, eConsent is an early adopter platform that is projected to enter the early majority in 2021. This is a crucial technology when considering ways to move your clinical operations off of paper as well as how to meet the convenience and technology expectations of potential study participants. If you do not have eConsent you should begin exploring this technology.

eSource: At 21% planned adoption by the end of 2020, eSource is expected to enter early majority in 2021. If you are not investing in eSource – either direct data entry or automated collection from the EMR – you should explore this technology in 2020.

Now more than ever, taking a critical inventory of your research site technologies is essential to understand where you will fit in the scope of the modern clinical trial. Will you be equipped to pivot to remote operations if needed again in a future disruption like natural disasters or public health risks, can you meet the growing demand of technologically savvy clinical research professionals, and can you prove that your operations are as efficient as they could be? If the answer to any of these questions is no, it is time to start making changes.

Florence can help. Contact us today for a free consultation and ROI analysis.