With substantial experience in this field, Almac Clinical Technologies sought to address these pain points through the analysis of over 3,000 clinical trial protocols to identify common needs and functions that can be consolidated into a pre-validated and fully configurable clinical workflow ecosystem. The result is Simplify™, an IRT solution that allows clients to use and configure pre-validated tools and components to help sponsors and investigators focus on trial conduct.
With Simplify, trial workflows can be designed and implemented in days to weeks – depending upon complexity. The specific investigational products, dosing regimens, and patient inclusion/exclusion criteria are unique to each trial, but the underlying designs, randomization plan, and product distribution needs are familiar. Sponsors that don’t want—or have time—to be slowed by extensive discussions around trial requirements, documentation, and User Acceptability Testing (UAT) can pick and choose from pre-validated elements to create and implement the needed IRT system functionality in record time.
Sponsors simply select the functionality (via configuration document) needed for a particular trial, thus reducing the volume of documentation that must be reviewed and signed off in design and UAT. Without a pre-validated route, these time-consuming and laborious steps become high-overhead milestones on a slow journey toward commercialization.
Since core functionality is already configured, tested, and validated in Simplify, sponsors can concentrate on configurations for their specific trial. This is a huge improvement over traditional e-clinical solutions where clients can expend considerable effort reviewing and testing every aspect of trial software.
Simplify, combining fully configurable elements, is highly flexible to meet specific sponsor requirements while saving time and reducing overhead. In the current COVID-19 environment where time is of the essence, Simplify has helped sponsors move from sign-off to patient enrolment in as little as seven days. If the scope changes or evolves after the trial begins, complex and customized functionality can easily be added as needed. Few pre-validated platforms have the flexibility to expand during later-stage trials in this manner.
Streamlining the management of patients and supplies
Once a trial is launched, Simplify automates the randomization of patients, product assignments, and tracking/order supplies. Real-time dashboards and alerts improve trial efficiency with less lag in managing cohorts and monitoring progress. Reporting mechanisms provide real-time analytics to trial monitors, sponsors, and investigators supporting efficient and timely decision making. Dosing decisions, even enrolment decisions, can be based on a complex interplay of biomarkers, laboratory values, and other factors in addition to more familiar patient demographics.
That same focus on efficiency means sponsors can create and manage dynamic supply strategies based on real-time product usage rates and today’s forecasts, not the assumptions and forecasts set before the trial was launched.
In summary, Simplify has the flexibility to accelerate rule-driven decision-making to get trials started faster and conducted more efficiently with fewer hands-on hours from managers who are already overburdened and under-resourced. Doing more with less, and doing it faster, is a strategy for success.
Best experience, best results
Sponsors, CROs, and investigators are doing more and more complex trials than ever before, and with fewer staff and resources at their disposal. The Simplify IRT system allows sponsors to implement and use the functionality they need in a manner that removes unnecessary complexities. This approach helps to reduce the time it takes to initiate a clinical trial so that much-needed therapies get to patients faster than ever before.
When time is of the essence, such as in the face of a global pandemic, IRT systems can truly be a game-changer by helping efficacious drugs show benefit as soon as possible and at a lower cost. Sponsors win, investigators win, and, most importantly, patients win.
To find out more about our IXRS®3 IRT Platform click here.