In 2007 Synergy opened a Clinical Data Management Department with local, low-budget projects and decided to implement an open source EDC solution as a clinical data collection tool. This tool required installation and validation every time a new project was started. When the number of projects started to multiply, management quickly realized they had two options: expand their IT resources to support data management applications or outsource. They chose the second option so they had to find a cost-effective, pay-as-you-go, cloudbased EDC solution which would allow them to move their current EDC projects without interruption.
Mid-trial decisions to address unexpected issues—such as a product shortage—deserve to be made with all the facts. Often, those facts are hard to come by and require visibility to the entire supply chain. That was the case for one sponsor conducting a complex Phase III trial across a number of countries. Almac Clinical Technologies and Almac Clinical Services teamed up to provide a complete risk assessment and cost analysis of various solutions, making the most cost-effective choice obvious.
Managing large global trials involving tens of thousands of patients is only possible with the help of automated systems such as Almac’s IXRS. Yet, even with the use of software to randomise patients and manage kit assignments, anomalies can crop up in the way that sites deal with patients and kits.
Protocol changes—even those made because a drug is performing better than expected—can wreak havoc with study timelines and budgets. When one emerging biotech faced a protocol change that would render the IRT system for Part II of the study unusable, Almac staff snapped into action with a creative, schedule-saving solution.
What do you do when a “what if” scenario becomes a distinct possibility and has the potential to interrupt your mega-study involving over 10,000 patients in hundreds of sites in various countries around the globe.
A classic 3 + 3 study design to find the Maximum Tolerated Dose (MTD) may be straightforward and rule-based, but that does not equate to “simple.” One U.S.-based study team responsible for testing an oncology drug on two continents, quickly realised this.
Imagine a sponsor, a Contract Research Organization (CRO), and Almac Clinical Technologies all focused on the success of a clinical program involving five Phase III trials. Add in the need for 24 system amendments within six months, and you have the very definition of complexity. Using superior project management expertise and relationship management skills, the Almac team flawlessly implemented all system amendments on time.
In IRT design, as in life, timing is everything. System specifications shared during the requirements gathering phase are usually no problem for developers. But those same specifications, shared days before the study “go-live” date for a global trial conducted in multiple languages, present an enormous challenge. When one sponsor learned of last-minute changes to their IXRS required by regulators, the study team had little hope that they’d meet their announced study start date. Almac’s Clinical Technologies team, however, was determined to help the sponsor launch the study on time.
Imagine British computer scientist Tony Hoare once said, “There are two ways of constructing software design. One way is to make it so simple that there are obviously no deficiencies. And the other way is to make it so complicated that there are no obvious deficiencies.” Almac Clinical Technologies always subscribes to the first approach, even when elements of the study protocol could add additional layers of complexity to IXRS. This was the case when one sponsor wanted the study’s IRT system to accommodate a very flexible protocol.
The sponsor needed to know if almac clinical technologies’ ixrs could accomodate certain deviations to the standard dispensing rules and visit schedule.
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