Complex Innovative Designs

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Almac Clinical Technologies is home to the industry’s only in house Biostatisticians and Adaptive Design Center of Excellence.

Complex Innovative Designs require flexible solutions and a world of expertise. Almac Clinical Technologies has an unrivalled reputation for providing IRT software that enables an unmatched level of flexibility. Our team is 100% dedicated to your IRT randomisation implementation, which means you have access to the industry leading expertise needed to successfully implement your adaptive trial.

Almac’s extensive experience includes IXRS® implementation of clinical trials involving adaptive designs, including:

  • Master Protocols
  • Platform
  • Basket
  • Umbrella

With over 20+ years of experience, Almac Clinical Technologies is uniquely positioned to turn our expertise into innovative solutions for your clinical trial.

Read how Pancreatic Cancer Alliance was able to accelerate the outcomes of their perpetual adaptive trial with Almac’s IXRS® platform.

Adaptive Trial Design – Center of Excellence

Access to industry leading expertise focused on successful implementation of your study’s complex innovative design.

  • Utilising best practices for design and implementation
  • Partnering with you to cover key question and considerations
  • Ensuring all IRT aspects are accounted for

Experienced in studies requiring multi-dimensional adaptations, sub-study and sub-group populations and perpetual adaptations.

  • Randomisation scheme built with flexibility
  • Seamless adaptions allowing ability to add, drop or change existing parameters
  • Avoids timely and costly amendments by allowing real time implementation
Complex Innovative Designs Delivered in Partnership

Almac is Compliant with the Clinical Trials Transformation Initiative’s Guidance for Master Protocols

Uniquely sitting within a clinical study’s EDC and database infrastructure, the web-based randomization system (WBRS) plays a vital role in the success of a Master Protocol design. It allows seamless, on demand adaptations including seamless onboarding of new treatment arms.

Based on CTTI’s guidance, we hit all the requirements for your preferred IRT vendor for Complex Innovative Designs.

  • Dedicated Biostatisticians creating complex randomization designs
  • Expertise in master protocol designs
  • Consultancy and guidance on WBRS implementation
  • Relationships across the e-clinical ecosystem as part of a team of partners
  • An understanding of the critical connections enabled through systems integration
  • Site and patient-centric response systems
  • A 24/7 global technical support service desk

Find out more about CTTI’s guidance documents for Master Protocols

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