Your Premier Randomisation Partner for Biostatistics
Our in‑house Biostatistics Group, comprised of experienced Biostatisticians and Biostatistics Data Managers, is 100% focused on randomisation and IXRS® implementation. Our Biostatistics team works on hundreds of trials per year. That breadth of experience empowers our team with a wealth of knowledge in randomisation design, IRT implementation, and regulatory expectations.
Why Choose Almac Biostatistics?
A Trusted Partner for Collaboration: Providing you with the expertise and insight necessary to support informed and strategic decisions regarding randomisation design.
Adaptive Trial Design Expertise and Consultancy: Modern clinical trials frequently employ adaptive methodologies. You need a partner that can consult not only on your trial’s current randomisation but also anticipate future adaptations to ensure the IRT is prepared for any changes ahead.
Specialized Randomisation Service: Our Biostatistics team is well‑established with decades of experience focused exclusively on randomisation and its implementation in IRT. We cultivated specialized expertise in randomisation to efficiently and effectively support trial Biostatisticians with multiple responsibilities. We are a premier partner that offers specialized end‑to‑end support throughout your clinical trial as an extension of your team.
TMF ready documentation: Our service deliverables (e.g., schedule specifications, schedule files, biostatistics data solutions plans / reports) can be included within the Trial Master File (TMF) and assist with inspection readiness.
Established Expertise in Randomisation
Randomisation Specialists
Decades of experience in randomisation design, IRT implementation, and regulatory expectations
Statistical Memberships
American Statistical Association
Randomisation Working Group
Well‑Established Thought Leaders
Authors of multiple publications
Biostatistics Consulting Services
All our Biostatistics consulting services are delivered by experienced Biostatisticians and Data Managers.
Consultancy
Our services extend far beyond just schedule generation, and this is because consultancy is the heart of our services, leveraging our vast expertise in randomisation methods, IRT standards, and regulatory expectations to optimize efficiency, quality, and scientific rigor into your randomisation process.
Protocol Review
Our team reviews protocols for hundreds of trials annually, bringing extensive experience to every assessment. No matter how complex your randomisation method may be, our biostatisticians reliably create strong implementation strategies that thoroughly meet all protocol requirements.
Schedule Specification & Generation
Randomisation schedule generation is a critical, audit sensitive component of trial execution. Our team adheres to rigorous processes, protocol requirements, regulatory directives, and best IRT implementation practices to ensure statistical integrity, high quality, and regulatory compliance.
Schedule Management
Proper handling of source randomisation data is vital and subject to audits. Our Biostatistics Data Managers securely store all schedule data, guarantee its compatibility with IRT design, and ensure its precise uploading into the IRT.
Algorithm Specification & Validation
Algorithms like minimisation and response adaptive randomisation require statistical accuracy, real-time computation, intricate design decisions, and thorough validation beyond traditional randomisation schedules. Our team is highly skilled in implementing these algorithms through a rigorous process for specification, parameter selection, execution, and validation.
Randomisation Design Simulations
When it is unclear how different randomisation parameter choices will impact treatment balance or predictability, simulations offer a data-driven assessment under simulated real-world conditions. Along with conducting these simulations, our team delivers expert analysis to support the selection of optimal randomisation parameters.
Biostatistics Data Solutions
It can be challenging for Sponsors to navigate the intricacies of IRT data while maintaining blinding or independence. Our team can provide pre-system go-live UAT support, Live Trial Monitoring for IRT data, and End-of-Trial services. With comprehensive plans and expert SAS programming, our biostatisticians streamline complex data and deliver comprehensible reports that effectively illustrate IRT randomisation and kit assignment data.
Regulatory Support
Due to the stringent regulatory requirements surrounding randomisation integrity, consistent regulatory support is essential throughout the trial lifecycle. Our knowledgeable team is well-equipped to deliver comprehensive regulatory assistance for randomisation, including providing guidance, undergoing audits, facilitating reproducibility demonstrations, preparing TMF materials, and addressing other regulatory obligations.
What our clients value about working with Almac Biostatistics
Complex Designs & Delivery
“Despite tight timelines and a complex randomisation 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.”
“Almac Biostatistics Group has been extremely helpful and responsive to our study needs.”
Communication & Partnership
“Great service — strong scientific guidance and clear understanding of sponsor needs.”
“Excellent support and responsiveness — always available, with very quick responses.”
“Communication is always smooth and efficient. The biostatisticians are highly knowledgeable.”
“Clear communication and a consistent focus on the customer.”
FAQs
Almac’s Biostatistics team can generate any type of schedule needed for your clinical trial through following robust specification documentation and utilizing SAS® programming. With extensive expertise, our specialists can custom tailor SAS® programs to address a wide range of design and protocol needs.
- Randomisation – from simple designs (e.g., blocked randomisation) to complex (e.g., variable blocks, multi‑step randomisation, maximum tolerated imbalance (MTI)); also, to accommodate any IRT randomisation need (e.g., cohort management, replacement randomisation, re‑randomisation, adaptive designs, master protocols, complex dose optimzation).
- Clinical Supplies Kit Lists – from standard designs for open label and double‑blind supplies to more complex approaches like vial / carton level / shippable units.
- Random Numbers Lists – typically used for Probabilistic Assignments / Algorithms, or to address specific custom IRT functional need (e.g., authorisation numbers, shamming).
Through protocol review, listening to Sponsor needs, and expertise in IRT randomisation, our Biostatisticians will derive and present a balanced set of options for implementation. For each option, our team will deliver a comprehensive evaluation, outlining important factors to support informed decision‑making to identify the best solution.
Yes, Almac can support Randomisation and Clinical Supplies Kit Schedules generated by outside sources such as the Sponsor or other vendor. Our Biostatistics team have robust processes for the management of externally generated schedules including receipt confirmation, secure storage, IRT compatibility assessment, and accurate uploading into the IRT.
Almac’s Biostatistics Data Solutions help sponsors navigate IRT randomisation and kit assignment data through providing easy to understand plans and reports.
- Pre‑System Go‑Live (Initial or Subsequent Builds): It benefits Sponsors during the UAT to provide IRT outcomes in language both non‑biostatisticians and biostatisticians can understand so they can more efficiently evaluate the acceptability of the IRT system.
- During the Trial: As regulatory bodies have high expectations for the integrity of critical data (e.g., randomisation) – our plans and reports satisfy their requirements for Live Trial Monitoring.
- End of the Trial: Our reports also allow for efficiency in reporting randomisation at the End of the Trial by providing objective evidence of how randomisation / kit assignments were performed within the IRT.