Andres Garcia, Chief Technology Officer at Florence Healthcare

In my previous article, I emphasized the importance of technology vendors opening up their systems to enable collaboration with other vendors, sponsors, CROs, and sites in order to advance clinical research and ultimately benefit patients waiting for treatments or cures that may not currently exist – “playing well in the sandbox” together.

We are entering a critical phase in which open collaboration will be an essential way forward to truly make a dent in the increasingly difficult challenges that clinical research operations face. 

As science advances by giant leaps, the operational aspects of clinical research are lagging significantly and not moving at the same pace. Clinical operators, including Sponsors, CROs, and Technology vendors, need to become adept at having their systems talk to each other while still maintaining their independence and ability to innovate at different speeds.

It’s no surprise that many of the operational challenges we experience in the clinical research industry are self-inflicted. Interoperability, standardization, operational excellence, and efficiency have been solved in other industries for decades. One example is the financial industry, which has successfully implemented standard protocols like SWIFT for secure and efficient communication between banks.

To achieve these goals in clinical research, there must be a cultural shift towards open collaboration, interoperability, and the willingness to embrace change from all industry players, including vendors like Florence.

The operational changes required in the Clinical Research industry are not rocket science. From a technology standpoint, they are well known and arguably “easy” to address. The major challenge lies in the attitude of industry players to embrace this type of change.

At Florence, we understand that we represent a small yet crucial part of the larger clinical research operations ecosystem. No vendor can claim that they “do it all.”

Our most important job is to create software that enables sites to perform better, faster, and more efficiently while running a trial. We don’t stop at providing great software; we ensure that our software can be used as a component of a much larger infrastructure that includes other systems, which when combined, create enterprise workflows.

Let’s discuss a few concepts that will help clarify this idea.

• Automation: The programming of tasks or series of tasks to be executed without the need for human intervention.
• Integration: The process of bringing together various types of software subsystems to create a unified single system.
• Orchestration: The coordination and management of multiple applications and/or services, stringing together multiple tasks to execute a larger workflow or process.

We believe that creating software with solid bi-directional APIs is essential for industry progress and for creating integrations across systems and vendors that serve our customers’ needs.

The next frontier for the progress of our industry includes solutions that transport and transform data and documents across multiple systems and vendors. Examples include initiating a trial in a CTMS, which generates the study space in an eISF, automatically routing IRB documents through different systems, or completing a consent form by a patient and automatically routing it to the ISF, which in turn creates other mechanisms.

In my next article, I will explore some examples in more detail and discuss the characteristics that a vendor should exhibit to be a good candidate for enabling orchestration of workflows across systems.

I encourage all industry players – technology vendors, sponsors, CROs, and sites – to:

1. Evaluate and reassess your current systems and practices in light of interoperability and collaboration.
2. Engage in dialogue and partnerships with other industry stakeholders to identify opportunities for improvement and synergies.
3. Actively seek and implement solutions that promote collaboration and streamline clinical research operations.
4. Advocate for the adoption of industry standards and best practices, and invest in the development of solutions that meet these criteria.
5. Share your successes and lessons learned with the broader clinical research community to foster a collective growth mindset.

Together, we can work to break down barriers, embrace innovation, and create a future where clinical research operations are more efficient, effective, and patient-centric. Let’s take the first step by committing to open collaboration and interoperability, and work collaboratively to shape the future of clinical research for the betterment of patients worldwide.