- Clinical Technology Services
- Advanced Drug Supply Support Services
- Integrated Supply Chain Management
- Patient Management
- ePRO Solutions
- Biostatistical Services
- Almac Interactive Reporting™
- Clinical Helpline
Almac offers world-class Biostatistical Services related to patient randomisation methodologies, IXRS® implementation considerations and electronic Patient Reported Outcomes (ePRO). The strength of this offering revolves around the quality of Almac’s Biostatisticians, their expertise, experience, and reputations in the clinical R&D community.
Almac’s Biostatisticians can provide consultancy advice relating to crucial aspects of trial planning such as study design, randomisation strategy, blinding and regulatory considerations. In addition, Almac is a renowned industry leader in providing expert advice in complex study designs (e.g., adaptive trial design implementation, covariate adaptive [dynamic] randomisation methodologies and cohort designs).
From simple to complex studies, Almac’s knowledgeable and customer focused Biostatistical Consultants will ensure that your needs are fully understood and accurately implemented within the IXRS® so that study objectives are fully met.
IXRS® Randomisation Methodologies
- Permuted block list approaches (central, simple through to complex stratification)
- Covariate adaptive (dynamic) randomisation methodologies, including:
- Pocock & Simon Minimisation with Biased-Coin Assignment
- Dynamic Hierarchical methodologies
- Custom methodologies
- Adaptive Trial Designs, including:
- Fixed interim designs
- Bayesian response adaptive algorithms
Dedicated IXRS® Biostatistical Consulting
- Selection of methodology & associated parameterisation:
- Choice of stratification factors and/or block size
- Optimal set-up for covariate adaptive randomisation
- Regulatory considerations
- Simulation programs available to enable quick determination of optimal methodology
- Impact on supply requirements/overage
- IXRS® implementation of Adaptive Trial Designs
- Considerations related to forced randomisation, subject replacement, randomised sub-study assignment, re-randomisation, etc.
Randomisation List Generation Services
- Subject Randomisation Lists
- Fixed/ variable block sizes, stratification, cohorts, sub-study assignment, subject replacements lists, re-randomisation, etc.
- Clinical Supply Kit Lists
- Double-blind & open-label kit lists
- Random Number Lists
- For biased-coin assignment, authorisation codes, etc.
ePRO/ Psychometric Support
- Guidance on regulatory considerations
- Assessment of instrument migration from paper to IXRS® (phone & web)
- Provide psychometric consulting in relation to instrument use & implementation in IXRS®
- Consult on instrument validation
Almac’s customer service is consistently rated one of the highest in the industry by sites and sponsors. Our project teams go above and beyond to ensure that all users’ needs are met throughout the life of a trial.
Almac’s technology and services have been deployed globally since 1995 in over 85 countries and 60 languages.
Satisfied users are productive users. Almac is always looking for new ways to improve the user-friendliness of our technology.
Almac has conducted over 1900 clinical trials worldwide, involving 1.8 million patients at 130,000 sites in over 85 countries and 60 languages. Our clinical technologies’ client base includes approximately 250 firms, with several Top 50 biopharmaceutical firms and over 150 small and medium-sized companies.