Study Change Requests – A Test of Agility, Efficiency and Experience


Clinical studies are like fingerprints: no two are identical. The notion of a purely “configured based system” is a myth.

Study protocols are becoming more complex and trials are dying faster, with patient recruitment remaining the number one problem. We’re seeing more and more studies with protocols that change as we are configuring the system in our IRT environment, or that change shortly after go-live. In fact, about 50% of studies will need a protocol amendment, often on the fly.

Read the Whitepaper: Top Five Reasons You Need IRT Expertise, Not Just Software

When a sponsor requires an amendment it triggers the change control process, or what we call a Study Change Request, or SCR. These can be simple, like clarifying usage instructions; or they can be significant, like requiring changes to the study design.

This trend is being driven by costs. Sponsors want to save money by doing fewer, more complex trials. The thinking is that if a sponsor runs one large, complex trial with a flexible protocol they can get results quicker, and make changes as they deploy.

Of course, because of reporting requirements sponsors want changes completed as soon as possible. But speed doesn’t necessarily translate into quality, and mishandled SCRs can delay a study for months, or even kill it. Clients have to trust in the experience and skillset of the IRT provider’s team and their ability to fulfill SCRs while scrupulously maintaining data integrity and patient convenience and safety.

Building in Innovation, Quality and Expertise

Cenduit’s quality-first CIRT platform and Quantum Interactive™ design tools are supported by a team whose integrity, commitment to quality and experience are changing the way biopharma views project management. Our world class Project Management and Client Oriented Resources & Engagement (CORE) teams continually refine our processes as we work with clients to define, build, test, confirm, and deploy quality studies.

Our teams create client delight by listening closely to clients and to the voice of the patient. We align technical resources with our CORE teams, whose deep relationships with clients give us insight into how they implement studies. This enables us to build studies with as much planned as possible before go live. Unknowns and changes don’t trouble us, because our team has the expertise to react quickly and adapt a study – often in days – while ensuring continuous compliance following our robust SCR processes.

A core principle of our service delivery model is to redefine the Operational Excellence model. Quality is built into our culture, and it affects each piece of the process and workload. We call it “industrializing our operations.” (You can read more about our OpEx approach in my blog Where OpEx Meets Client Delight.) We use a Lean methodology and Lean efficiencies to strengthen our unique methods, and deliver delight to our clients. In addition, we host an internal virtual innovation platform that helps us innovate new ways to keep studies moving smoothly by providing a central place for our teams to share ideas.

SCRs are a fact of life. Contact us to learn how your organization can leverage our innovative technology and processes to deploy customizable, configurable studies with the quality built in to handle SCRs quickly while maintaining data integrity and patient safety. 

 Posted by Christopher Gent, Associate Director, Operational & Process Excellence