Tech overload is among the greatest challenges sites have when they take on new clinical trials. The average clinical research center has to manage multiple platforms daily, an expectation made much harder by labor shortages.
But for many sites, it’s not just sponsor-provided tools they use. Large institutions often invest in their own tech stacks to make the everyday juggling of protocols and patient care more efficient. The tricky part comes when those sites try to integrate their technologies with those of sponsors. Conflict abounds, timelines get delayed and launches postponed when teams, tools and workflows are incompatible.
Now more than ever, stakeholders need harmony among their disparate systems — and that starts with the right organizational mindset: a culture of connectivity, if you will. Solutions alone can’t solve these frictions and organizations need to think more broadly, said Vishal Janani, Director of Product Management & Strategy, Life Sciences Products at Cognizant.
“You need pharma companies, sites and technology providers to come to the table and ensure that the whole ecosystem works in unison, not just the technologies,” he said. “When you approach program management, governance and contracting in a standardized way, you can start to enable clinical operations transformation.”
How can life sciences companies support this culture of connectivity? Here’s what experts recommend:
Standardize how you standardize
Despite its name, standardization is internally established and not always commonly defined. Even if one sponsor “standardizes” its approach with sites, that consistent process can differ from another sponsor’s consistent process.
So clinical trial stakeholders should be open to collaborating across companies, aligning on unified definitions and processes and being open to accepting change.
“You want to harmonize so that an organization is open to collaborating not just with sites, but also their competition,” Vishal said. “This starts by agreeing on common definitions and templates across technology implementation, governance and contracting, for example. Everyone can work as a single unit to define something which would then be used repetitively thereafter.”
Standardizing technology management
The messy existence of multiple sponsor and site systems creates a need for something that sits in the middle — an integration hub (such as Cognizant’s) that standardizes technology into a consolidated, API-powered space. That’s because the alternative, point-to-point integration, simply isn’t scalable with the volume of platforms in use today.
“A large sponsor has around 20,000 study sites across more than 4,000 facilities and if each of them has their own system, it’s going to be a humongous task to integrate that,” said Kavitha Lokesh, Vice President, Life Sciences Products, at Cognizant. “You can either expose the APIs from your system directly, or you could plug into that integration hub, which itself standardizes all connections.”
That last part is critical, Vishal added:
“The way you design those APIs has to be system-agnostic so that irrespective of the source system, you can leverage the same data across vendors and sponsors without much coding. That supports maintenance and management of the technology, too.”
Standardizing contracting, security and regulatory compliance
Standardization also requires a consistent approach to service-level agreements, security and regulatory compliance. By establishing common expectations and templates, stakeholders can more easily bypass additional negotiations, fast-track connections and ensure data integrity and compliance from vendor to vendor.
“When we standardize the contract, both parties know what they’re getting into, even before initial discussions or work take place,” Vishal said. “It takes away effort and time required to integrate systems and bring sponsors and sites together.”
Standardizing governance and program management
Governance is the glue that holds standardization together and it also holds stakeholders accountable for a consistent vision. When considering standardized governance, Vishal suggested starting simple and progressing from there.
“The first thing is to participate in a central governance and become an active participant of that body,” he said. “Secondly, you need a well-defined charter to establish the role of that body and its approach to everyday operations.”
Charters should include ensuring the security of integration, as well as details such as meeting cadence, new vendor engagement, data management and more, he added.
Achieving a culture of connectivity
As the deluge of platforms hits an unscalable point, sponsors and sites both need a more sustainable solution, Kavitha said.
“Every sponsor is rolling out their platform and expecting sites to come onboard,” she said. “In the meantime, sites are developing their own systems. And that’s the question the industry is asking: How can we connect?”
But remember, it’s not just about the technology, Kavitha added. Transformations require a larger context of standardized contracting, governance and more. With those elements in place, the technology itself becomes more practical.
“We have to give autonomy to the sites and the sponsors,” she said. “Integrating systems and the culture at large, across a complete digitization process is a key steppingstone to get there.”
Looking for a more standardized approach to integrating sponsor and site systems? Cognizant can help.