Bringing Quality, Innovation and Experience to Rescue Studies

 
 

Can you really improve the economics and safety of clinical studies by choosing expedience over expertise?

The answer is a decisive “no,” from every sponsor who’s asked Cenduit to rescue a study after initially choosing an eClinical suite for convenience – only to learn that the IRT module was bolted on, unintegrated, inflexible, and unsupported.

You Get One Chance to Make a First Impression

Too often, sponsors experience problems when their Interactive Response Technology (IRT) is tacked onto a large eClinical suite, without the proper service delivery strategy behind it. The suite providers don’t always understand how to use or support IRT, and sometimes the study hits a wall: The EDC module won’t talk to the IRT module. The drug file order formats don’t adhere to the required standards. Complex supply chain needs go unmet, so the supply chain doesn’t function. Data integration outside the eClinical suite is difficult, costly and time consuming. The list goes on…

The Best IRT System: Invisible and Invincible

IRT exists to randomize patients and control the flow of the study drug. We firmly believe that the best IRT system is the one you never see. Functional systems hide the complexity and keep the user experience super simple, allowing sponsors and sites to focus on their day jobs – looking after patients!

Over the past several years, sponsors have asked Cenduit to take over and rescue studies from technology providers whose IRT implementations didn’t meet expectations. Cenduit focuses on best-in-class IRT. We know how to build truly integrated IRT systems, and people choose us to rescue studies because we’re an integration solutions provider – on every study we deliver. Our System Design and Client Service teams’ wealth of experience and service orientation, combined with Cenduit’s philosophy of consistent innovation, allows us to build high quality, reliable systems for nearly every phase and type of clinical trial from the simple, to the most complex.

Re-Navigating Randomization and Drug Supply While Mitigating Risk

Consider what’s involved in swapping out an IRT system. The system and its technology exist to randomize patients into the study, in a way that is controlled and safe. We approach each rescue study with care. We take a very responsible and prudent approach, always remembering that at the end of the line there’s a human being, often going through a challenging health issue.

Before Cenduit can even begin the process of accepting a rescue study, our experts carefully and thoroughly review the broad situation. Namely, we assign team leads in design and management to carefully review the planning process and develop potential ideas. Our adoption of rescue studies focuses on those that can add real value to the sponsor. Should we discover other issues affecting study operations that have nothing to do with IRT, we identify those issues for the sponsor up front.

Building a Quality Rescue Study – Communication and Collaboration

When Cenduit does accept a rescue study, we immediately begin to address the sponsor’s concerns...

• We meet quickly – often within days – with their study team for a fact-finding mission

• Early in the process, we analyze what’s happening across multiple levels, listen to all parties, and create a mitigation plan of action

• We set expectations promptly, and never over-commit

• We work with the technology provider that’s been de-selected to put the pieces back together in a way that scrupulously maintains data integrity and patient safety

We are meticulous in how we design and deploy any study. If we’re rescuing an existing study, our team also has to reverse-engineer and cross-map existing data. That’s not simple. When we undertake a rescue, we have an inherent responsibility to make sure that we don’t interrupt the operation of the study, while we transition from one system to another. We’re fastidious in maintaining accurate randomization and trial supply management information so that the right kit gets to the patient at the right time - always.

Cenduit is committed to offering our clients tools that help them regain a sense of ownership of their studies and improve daily operations. These tools include…

Early integration demonstrations – our teams prepare demos of how their IRT system and integrations will work very early in the process, so there are no surprises

• Dashboards – these include self-service tools that sponsors and sites can use to save time and maintain control over their studies and patients

• User guides – part of the essential playbook we build for each IRT system, Cenduit prepares and translates detailed user guides for sites, and provides full training to ensure sites are comfortable with the new system

24/7/365 help desk – we staff our global team of IRT experts with the goal of first resolution, with an interactive chat and screen sharing capability, speaking to sites directly for real-time issue resolution

Do the Right Thing, Always

Every day we ask ourselves how we can benefit the patient, reduce costs for sponsors, speed trial delivery, ensure data integrity, improve the supply of drug, and eliminate the potential for study disruption (such as missed patient visits). Our team-based approach, and wealth of experience navigating the rescue study process, combined with our service-oriented culture can truly deliver studies that benefit biopharma’s real client – the patient.

We’d welcome the opportunity to show you how our people and services can help your organization build quality clinical studies that can improve healthcare outcomes.

Posted by Dan Pavitt, Associate Director of Business Solutions

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