Advanced Clinical Trial Framework

Assess

Conduct a thorough needs assessment to understand the specific requirements and objectives of the trial, ensuring alignment of all stakeholders and identifying potential gaps.

Details:

Stakeholder Engagement:Involve all relevant stakeholders, including clinical teams, patients, regulatory bodies, and sponsors, to gather comprehensive requirements.
Gap Analysis:
Identify any gaps or challenges in the current trial design and execution plans.
Technology Assessment:Evaluate the readiness of current technologies and platforms to support the adaptive trial.

Benefits:

Alignment:Ensures all stakeholders have a shared understanding of the trial's goals and requirements.
Risk Mitigation:Identifies potential issues early, allowing for proactive risk management.
Efficiency: Saves time and resources by addressing gaps before the trial begins.

Outcome:

Deliverables: Saves time and resources by addressing gaps before the trial begins.

Readiness assessment report evaluating the current technology and process readiness.

Gap analysis report identifying potential challenges and areas for improvement.

Specify

Produce a detailed design specification in a standardised format, outlining all design requirements and essential components.

Design the data management plan and intelligent Case Report Form (CRF) to maximise automation opportunities, ensuring high-quality data collection and management.

Details:

Design Specification:Develop a design specification that includes all essential elements needed by the design partners, such as Berry.
Standardisation:Ensure the design specification is in a standardised format that meets the needs of external consultants and partners.
Technology Utilisation:Use the Protocol Builder tool to generate and refine the design specifications.

Benefits:

Clarity:Provides clear and detailed preliminary specifications for trial design, reducing ambiguities.
Consistency:Standardised formats ensure consistency and ease of understanding for all stakeholders.
Preparation:Prepares the trial design for efficient execution and regulatory review.

Outcome:

Deliverable: A comprehensive preliminary design specification document that serves as a blueprint for the adaptive trial design.

Simulate

Perform statistical simulations to evaluate and optimise the adaptive trial design, enhancing trial efficiency and reliability.
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Details:

Simulation Tools:Use Berry consultants to conduct robust statistical simulations.
Design Optimisation:Evaluate various trial design scenarios to identify the most efficient and reliable configurations.
Performance Metrics:Assess key operating characteristics, including impact of alternative end-points, populations, stratification, and assumptions regarding size of treatment effect and incidence of primary end-point including impact on type I and type II error. Specification of factors that influence trial duration, cost, and likelihood of positive trial result.

Benefits:

Optimization:Identifies the most effective trial design, maximizing efficiency and reliability.
Informed Decision-Making:Provides data-driven insights to guide trial design decisions.

Outcome:

DeliverableA detailed simulation report with optimised trial design recommendations.

Design

Automatically generate a detailed trial design, including protocol documents, ensuring compliance with regulatory standards and industry best practices.

Details:

Protocol Development:Use the Protocol Builder tool to create a comprehensive trial protocol.
Regulatory Compliance:Ensure the trial design meets all regulatory requirements and industry standards.
Collaboration and Documentation:Record trial design meeting minutes and link decisions to configuration choices within the trial builder.

Benefits:

Quality AssuranceEnsures high-quality trial protocols that facilitate smooth execution.
Regulatory Readiness:Aligns documentation with regulatory requirements, simplifying approval processes.
Efficiency:Accelerates protocol development through automated tools and processes.

Outcome:

Deliverable:Complete and regulatory-compliant protocol documents, ready for trial execution.

Automate

Design the data strategy and intelligent Case Report Form (CRF) to maximise automation opportunities, ensuring high-quality data collection and management.

Details:

Data Strategy Development:Use the Data Designer to create a bespoke trial data strategy, leveraging preconfigured variables and standardised data instruments.
CRF Design:Develop detailed CRF designs that incorporate automation opportunities and advanced validation rules.
Integration:Ensure the data strategy and CRF designs are compatible with Clinical Trial Management Systems (CTMS) for seamless integration.

Benefits:

Data Quality:Ensures high-quality data collection and management through detailed validation rules.
Automation:Maximises efficiency and reduces manual errors by automating data processes.
ComplianceEnhances compliance with jurisdictional data protection laws.

Outcome:

Deliverable: High-quality, automated data collection and management processes, with approval-ready documents for regulatory submission.

Adapt

Offer continuous support throughout the trial, including adaptive design modifications, ensuring the trial remains on track and responsive to emerging data.

Details:

Ongoing Support:Provide continuous support to adapt the trial design based on emerging data and changing conditions.
Monitoring and Modifications:Regularly monitor trial progress and make necessary design modifications to maintain efficiency and effectiveness.
Technology Expansion:Plan for future technology expansions to support ongoing adaptive capabilities.

Benefits:

Responsiveness:Ensures the trial can adapt to new data and changing conditions.
Support:Provides ongoing support to address issues and optimize trial performance.
Future-ProofingPrepares for future expansions in adaptive capabilities.

Outcome:

Deliverable: A dynamic and responsive trial design, with ongoing support to ensure the trial's success and adaptability to new data.

Smart Trial Framework

Assess

Specify

Simulate

Design

Automate

Adapt