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.
EO2 Concepts is an advanced wound care technology company. The company develops and commercializes electrochemical low-dose tissue oxygenation and wound monitoring systems. Their flagship product, TransCu O2®, is an FDA cleared Class III medical device intended to treat difficult to heal wounds such as venous leg ulcers, diabetic foot ulcers and pressure ulcers.
Intuitive Surgical, worldwide leading technology medical device company, was expanding the use of their number one medical device to new therapeutic areas. It counts over 1,670 surgical systems installed in over 1,500 hospitals. This post-marketing study was key to show how their surgical robot could benefit other types of surgery. The sponsor was looking for a way to efficiently manage such large amounts of data while staying on time and on budget.
Providence Medical Technology, a fast-growing medical device company with its headquarters in Lafayette, CA, was seeking a rapid and accurate method to collect data for its retrospective observational clinical study.
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