Our in-house biostatisticians and data managers have a deeper understanding of protocol-specific randomisation nuances and are able to synthesise impact analyses well beyond the capabilities of our competitors
Regardless of the size or complexity of your clinical trial, let our biostatistics professionals be your trusted allies, giving you the insight that you need to make the optimal randomisation decisions that benefit your patients and enable better trial outcomes.
Clinical Biostatistical services
We are the industry leader in complex clinical trial designs and consultancy for randomisation implementation. Our renowned expertise covers a broad range of randomisation designs – from simple blocked randomisation techniques to adaptive trial designs, covariate adaptive randomisation, and complex innovative designs such as Master Protocols.
Our world-class Biostatisticians and Biostatistics Data Managers set us apart from the competition – their expertise, experience, and reputation are of the highest caliber in the clinical R&D community.
From simple to complex studies, our knowledgeable and customer-focused Biostatistical Consultants will ensure that the randomisation needs of your study are fully understood and accurately implemented.
Biostatistical consulting –
IXRS® Interactive Response Technology
Our in-house Biostatisticians offer upfront consultancy for randomisation methodology selection, blinding considerations, and IXRS implementation (based on extensive experience and a solid understanding of regulatory guidance) during the design phase. Their expertise will also be applied throughout your study’s life cycle to ensure its successful execution.
Simulation Services: Almac’s Biostatisticians can perform SAS simulations to facilitate data-driven decisions for randomisation methodology and parameter selection by comparing the expected treatment balance across various options/scenarios.
List Generation Services: Almac Biostatisticians can generate the required lists for your study (Subject Randomisation, Clinical Supplies Kit Lists). This service includes list specification documentation, generation of Dummy and Live versions via SAS, reports, list verification, delivery(s) / approval(s), and IXRS import/verification.
Biostatistics Data Management Services: Almac’s Biostatistics Data Managers are responsible for importing all lists into the Live IXRS. Almac has a robust process for the management of lists, receiving and analysing client-provided lists, and IXRS import / verification.
Other IRT Services & Support