Trial Implementation

Precision & Speed in
‍Clinical Trial Implementation

Discover how smarter, adaptive clinical trial design can accelerate development, reduce costs, and improve outcomes. Berry Consultants is a global leader in adaptive clinical trial design, leveraging Bayesian analysis and custom trial simulation to create more efficient, data-driven studies for drugs, biologics, and medical devices. From early-phase exploration to pivotal trials, our evidence-based approach supports better decisions at every stage.

Implement your trial design with confidence. Berry specializes in the seamless implementation of adaptive clinical trials, utilizing both Bayesian and frequentist methods to ensure precision, speed, and scientific integrity. From interim analyses to regulatory support, our statisticians and unblinded teams deliver expert guidance you need to keep trials on track and on time.

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Seamless Implementation

Efficient implementation with precision, speed, and operational excellence.

Clear, Custom Reports

Intuitive reports with clear visuals to support key trial decisions.

DSMB Integrity

Expert support for transparent, secure DSMB interactions.

FACTS (Fixed and Adaptive Clinical Trial Simulator) is the industry’s most powerful tool for designing, simulating, and analyzing adaptive clinical trials. With capabilities spanning from phase I dose escalation trials to adaptive platform trial designs - FACTS helps teams design custom trials to fit their unique clinical goals.

Adaptive Trial Implementation Process

At Berry, we understand that great trial design means little without flawless implementation. Our approach to adaptive trial implementation focuses on efficiency, precision, and seamless collaboration. Here's how we do it:

Seamless Collaboration: We work closely with clients’ operational teams and CROs to ensure smooth implementation of adaptive designs, no matter the complexity.
Rapid Interim Analyses: Our pre-built programming foundation allows us to complete interim analyses within 5 business days of data receipt, so decisions can be made without delay.
Unblinded Expertise: Our dedicated unblinded team, including expert statisticians, manages all interim analyses to maintain the integrity and confidentiality of your trial.

This process ensures your trial remains agile and efficient from start to finish.

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Reporting & Regulatory Support

Clear, comprehensive reporting is essential for trial success, especially when dealing with adaptive designs. Berry supports reporting, from interim analyses to final analyses. Our process includes:

Custom Reports: We create custom interim analysis reports with visualizations, combining clear tables and intuitive figures to make complex results easy to interpret.
Regulatory Guidance: We provide best-practice guidance on how to address regulatory agency feedback, ensuring your implementation plans meet expectations.
Publication Support: Our team offers comprehensive manuscript reviews to support your publication efforts, ensuring your research stands up to peer review.

With Berry's clinical trial expertise and reporting excellence, you’ll have confidence of every decision point in your trial.

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Data Safety Monitoring Board (DSMB) Support

For trials requiring oversight by a Data Safety Monitoring Board (DSMB), Berry provides specialized support for the unique requirements of adaptive trials. Our team’s experience includes:

Charter Development: We assist in drafting detailed DSMB charters that clearly define roles, processes, and communication plans.
Interim Analysis Presentations: Our statisticians present unblinded interim analyses to DSMB members in closed sessions, ensuring confidentiality and scientific integrity.
Expert Guidance: Our team members have extensive experience serving as independent DSMB members, giving us a unique perspective on how to present and interpret your trial’s data.

By partnering with Berry, you’ll have seasoned experts guiding your DSMB interactions, ensuring your innovative trial is implemented efficiently.

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Trial Design

Therapeutic Areas