Building in Quality to Design Trials for Change


Over the past several years, there’s been a ten-fold increase in the level of complexity in clinical trials, amid the speed of technological change in eClinical. The overarching reason: sponsors want to achieve increasingly ambitious research goals in a growing number of indications, across geographies and global patient populations, faster than ever before.

These environmental factors are driving the need for increasing flexibility to adapt and change studies. In this environment of “designing for change,” many sponsors are asking their eClinical technology providers to condense the clinical trial design and build process from months to weeks.

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

Efficiency and speed to expedite delivery are absolutely critical. Equally important: the ability to design for inevitable study changes. Today, we see system changes during system development, immediately post go-live and throughout the study lifecycle. This is due to the need to rapidly respond to regulatory input and market changes, as well as in response to analysis of study conduct data.

This rise in protocol amendments is an opportunity for sponsors to save on costs, particularly during mid-study changes. A sponsor might spin off of the initial protocol with an amendment to introduce a new treatment arm, cohort or drug type. Or, they might request a double-blind Phase I, and an open-label Phase II. While this might be less expensive for the sponsor, IRT providers must adapt to become much more creative within their study design.

Sponsors requesting increased protocol amendments can also trigger Study Change Requests, or SCRs. (Read my colleague Chris Gent’s piece on SCRs here.) Unless the underlying IRT system at the heart of the trial is both fully configurable and customizable, the requested change might not always be possible, or might not meet the desired amendment timelines. Conversely, increasing numbers of SCRs could have a negative impact on timelines, as well as on patient retention and safety. Or, SCRs could simply halt the trial entirely.

Deliver Change, Maintain Quality

The sponsor’s team is focused on the entire spectrum of the trial. With a hyper-focus on delivering the desired outcome for their study, a reliable, experienced IRT provider can keep the day-to-day operations running smoothly as unanticipated protocol amendments arise. Cenduit clients are confident in the configurability of our platforms, and in the experience of our teams to make protocol amendments not only possible, but seamless.

Designing IRT systems for change is always at the forefront of our build. Cenduit’s System Design and Client Service PM subject matter experts (SMEs) review and unravel even the most complex protocols. Our focus entails getting from spec to live as quickly as possible. When a client – whether a sponsor or CRO – asks Cenduit to incorporate a protocol amendment, our team rapidly:

  • Analyzes how the change will affect the trial moving forward

  • Determines the best way to implement the change

  • Works with multiple eClinical technology providers to make the change

  • Performs regression testing to ensure there will not be any negative impact on the trial

Keys to Ensuring a Configurable Trial

In the 8 years since I joined Cenduit, our team has consistently broken new ground in combining innovation and common sense to help clients navigate the clinical trial landscape. Our proven approaches include...

Setting Realistic Expectations – The Cenduit motto, “Do the Right Thing, Always” applies to every aspect of our client relationships. Our team does not over-promise what’s possible to deliver within the client’s timeline. We work closely with the client from the start to set clear expectations, with no surprises.

Dedicated SMEs for Each Facet of Trial Design, Build and Delivery – Our diverse, global/localized team of service experts includes dedicated, distinct System Design PMs and Client Service PMs who build and maintain client studies, and CORE teams for sponsors whose studies need a deeper consultative approach, such as emerging biopharmas. Our PMs become SMEs in their disciplines because they are 100% dedicated to their focus area; they do not split their time between building and maintenance. System Design PMs concentrate on the design and specification stage, while partnering closely Client Service PMs who provide expert maintenance.

Establishing Ongoing 1:1 Communications –Throughout numerous client satisfaction surveys, our clients rate Cenduit PMs and SMEs as delivering above and beyond in service excellence. Clients appreciate the level of detail, dedication, professionalism, and personal care. In fact, many clients tell us their professional relationships with our team members often develop into friendships, as they work together to achieve mutual outcomes.

Configurability – The Foundation of a Safe, Efficient Economical Trial

With customizable configurability and the agile build of an IRT system, changes take less time, with no disruption. Configurability and smart “designing for change” ensures that changes can be made at any time throughout the study quickly, and without timeline or cost surprises.

We’d welcome the opportunity to talk with you about how Cenduit quality, innovation and expertise can change the economics and improve the science of your clinical programs. Contact us to learn more.

Posted by Mark Gasdaska, Associate Manager, Project Management