Professional Services

Biostatistical Services, Systems and Data Integrations

 
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Trust our industry-leading experts for better trial outcomes

When you partner with Almac Clinical Technologies, you have access to experts who can help ensure the most optimal design and implementation of your protocol, as well as provide superior delivery of data transfers and integrations needed for your IRT system.

Our in-house biostatisticians and data services professionals have a deeper understanding of protocol-specific nuances and are able to synthesize impact analyzes well beyond the capabilities of our competitors. This is in part due to the vast experience with over 2,800 clinical trial specifics.

Regardless of the size or complexity, let our professionals be your trusted ally, giving you the insights you need to make decisions that benefit your patients and enable better trial outcomes.

Clinical biostatistical services

We are the industry leader in complex clinical study design consultancy. Our renowned expertise covers adaptive trial design implementation, covariate adaptive dynamic randomisation methodologies and cohort designs. Biostatistic Services in clinical trials will provide the information you need to make the decisions that will benefit your patients.

Our world-class Biostatisticians set us apart from the competition – their expertise, experience and reputation is 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 needs of your study are fully understood and accurately implemented.

Biostatistical consulting – IXRS® Interactive Response Technology

We are pioneers in adaptive and other dynamic clinical trial randomisation techniques. To assist you in the design and implementation of dynamic randomisation and dose titration schemes, our in-house Biostatisticians offer upfront clinical biostatistics consultancy during the planning phase. Their expertise will also be applied throughout your study’s life cycle to ensure its successful execution.

Selection of methodology and associated parameterisation:

  • Choice of stratification factors and/or block size
  • Optimal set-up for covariate adaptive clinical trial randomisation
  • Regulatory considerations
  • Simulation programs available to enable quick determination of optimal methodology
  • Impact on supply requirements and overage
  • IXRS® implementation of adaptive trial designs
  • Considerations related to forced randomisation, subject replacement, randomized sub-study assignment and re-randomisation.

 

Randomisation methodologies via IXRS® Interactive Response Technology

  • Permuted block list approaches (central, simple through to complex stratification)
  • Covariate adaptive (dynamic) randomisation methodologies, including:
    • Pocock and Simon minimisation with biased-coin assignment
    • Dynamic hierarchical methodologies
    • Custom methodologies
    • Adaptive trial designs

Adaptive trial designs

Well-designed adaptive trials result in lower drug development costs, reduced timings, faster decisions and improved patient safety. IXRS® Interactive Response Technology and eCOA (Electronic Clinical Outcome Assessment) tools capture safety and efficacy data and make it viewable in real-time – providing sponsors with the information they need, when they need it quickly.

We have implemented more than 100 adaptive studies and established a reputation as a market leader in adaptive trial designs including:

  • Fixed interim designs
  • Bayesian response adaptive algorithms

Clinical randomisation list generation services

Subject randomisation lists:

  • Fixed or variable block sizes, stratification, cohorts, sub-study assignment, subject replacement lists and re-randomisation.
  • Clinical supply kit lists:
    • Double-blind and open-label kit lists
  • Random number lists:
    • For biased-coin assignment and authorisation codes
      I. Rand List generation services
      II. ePRO (Electronic Patient-Reported Outcome) or psychometric support and services

Clinical trial data integration

Cost-effective and highly efficient strategies

Our clinical trial Data Services team is dedicated to creating strategies that can accommodate your needs quickly and methodically. We have extensive experience working with all formats necessary for data transfer and integrating with central laboratory systems, Clinical Trial Management Systems (CTMS), Drug Supply Management Systems (DSMS), leading Electronic Data Capture (EDC) software and other data analysis and management systems.

As partners, we take pride in finding solutions for the various clinical trial data challenges you may face. With our vast experience in nearly 2,500 integrations, we can also advise you on implementation practices common to your industry peers and help you implement common software technologies – improving your overall operational readiness and ease of adoption.

Through consultancy, our team works to identify relevant IRT data to integrate with any target system. We support numerous file formats, transmission methods and frequency needs. Custom decodes of data are also supported, to allow for reduced coding and the easier processing of data.

We are proud members of CDISC, which establishes standards for the integration of clinical trial data from all sources.

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