Your Premier Partner for Master Protocols
Master Protocols have more sophisticated needs and fundamental operational challenges compared to traditional clinical trials. Master Protocols can run for many years and may undergo several randomisation adaptations across the trial. Treatment arms can be introduced, paused, re‑introduced, retired; ratios may change; eligibility and site readiness may vary.
Why it Matters:
You need a randomisation partner that can support you with rapidly deployable, advanced technology today and can be trusted to innovate alongside you to meet future needs.
Why Almac for Master Protocols?
Almac is uniquely positioned in the industry to support Master Protocols.
In‑House Biostatisticians: With an in-house Biostatistics team, we can implement any type of randomisation design, no matter how sophisticated. Whether a flexible randomisation approach is the best fit, or other advanced designs like Response Adaptive Randomisation or Minimisation, our team can implement what is needed in IRT.
Adaptive Trial Centre of Excellence: You will have access to industry‑leading expertise focused on the successful implementation of your Master Protocol with an experienced cross‑functional team of IRT professionals.
Our Technology: Our randomisation technology includes a purpose‑built solution for the flexibility needs of randomisation in Master Protocols.
Longevity for Perpetual Master Protocols: Your Master Protocol may run for years, if not decades. You will need advanced technology today, along with a partner that will be innovating alongside you for the evolving needs of tomorrow.
Premier Randomisation Partner: We are the Premier Randomisation Partner for Master Protocols, as we meet all the requirements as indicated in Clinical Trials Transformation Initiative’s (CTTI) “Master Protocols: Operations Partner”1 guidance:
1 CTTI Operations Partners Assessment Tool
Learn more on our Adaptive Trial Designs webpage.
The Most Advanced Technology from the Most Reliable Partner
Benefits of Almac’s Randomisation Solution for Master Protocols
Ease to Use
Randomisation adaptations through a simple user interface.
Efficiency
Efficient randomisation adaptations without the burden of trial disruptions or costly IRT amendments.
Easy to Understand
Single, unified randomisation methodology for the life of the trial so that your team can focus on other important aspects.
Inspection Ready Reports
Regulatorily compliant reports that provide transparency for how randomisation has adapted over time.
Trusted and Tested Methodology
Implemented on dozens of systems in multiple therapeutic areas over the last decade. Our randomisation technology has been revised and refined in response to client feedback and regulatory guidance.
Speed and Agility
Our flexible randomisation technology for Master Protocols is now built into the IXRS platform. This solution is available for immediate deployment and can be custom tailored for your specific trial.
What our clients value about working with Almac for their Master Protocols
Despite tight timelines and a complex randomization algorithm, the team delivered outstanding support.
A smooth process, especially considering the complexity of the design.
The team developed a strong solution for our challenging design.
Great service — strong scientific guidance and clear understanding of sponsor needs.
We truly appreciate your insight and experience on this.