AI-Powered Biostatistical Validation for Contract Research Organisations

Win More Projects, Reduce Delays, and Optimise Your Trial Strategy

Leverage TrialKey’s advanced AI technology to optimise your clinical trial protocols. From preliminary design to full execution, we help you create data-driven, optimised trial protocols that increase RFP win rates, improve recruitment, and deliver successful outcomes every time.

Group analysis for AI-powered biostatistical validation in clinical research, optimizing trial design success rates

Request a free Preliminary Report

Benefits of Using TrialKey's AI Agent

  • Improved Productivity

    Automates data processing, simulation, and benchmarking, allowing teams to focus on higher-value tasks.

  • Reduced Costs

    Lowers costs by streamlining processes, reducing inefficiencies, and accurately predicting outcomes.

  • Informed Decision-Making

    Delivers reliable predictions and insights to refine patient recruitment strategies, endpoint selection, and site planning.

  • Better Stakeholder Experience

    Reports are concise, actionable, and designed to improve decision-making for researchers, sponsors, and teams.

  • Global Applicability

    TrialKey supports clinical trials globally, including drug trials, medical devices, alternative therapies, and novel conditions, across all phases from preclinical to late-stage trials.

  • Scalable

    The platform's scalable model caters to both small companies running a handful of trials annually and major companies running thousands of trials each year.

Optimised Trials: AI-powered graphics by TrialKey enhancing clinical trial design for biotech and pharmaceutical industries

End-to-End Reporting for CRO Success

Preliminary Business Development Report

Present a compelling case to sponsors with our AI-backed preliminary report. Designed to support your RFP, this 3-4 page report provides:

  • Success Probability Score: Showcase your trial’s projected success with our proprietary simulation.
  • Competitive Benchmarking: Show potential clients how your design compares to key competitors.
  • Visual Insights: Probability density graphs and other data visuals illustrate predicted outcomes.
  • Technology Landscape: A detailed analysis of technologies used in similar trials, complete with a success breakdown.

Learn more about the Preliminary Report here.

Comprehensive Execution Report

After securing the project, TrialKey provides a detailed, data-driven report to support every stage of trial execution, from protocol refinement to competitive analysis and risk mitigation. Our Full Report delivers:

  1. Site Selection and Recruitment Strategies
    Receive tailored recommendations on the best trial sites and patient recruitment methods based on our extensive data analysis. We identify sites with proven recruitment success and high patient availability to optimise enrolment timelines.

  2. Inclusion/Exclusion Criteria Optimisation
    Get data-backed refinements for patient eligibility criteria. Our analysis ensures criteria are optimised to enhance enrolment while maintaining statistical power and scientific integrity.

  3. Endpoint and Protocol Design
    TrialKey’s advanced AI simulations provide insights into primary and secondary endpoints, suggesting adjustments that can increase the likelihood of achieving trial success.

  4. Competitive Landscape Analysis
    Stay Ahead of Competitors in Your Therapeutic Area
    Our report includes a comprehensive view of the current competitive landscape. Using data visualisations like heatmaps and tree maps, we show which companies are actively researching the same condition. This section includes:

    • Key Players and Research Volume: Identify leading companies in your therapeutic area, their research investment levels, and trial activity. The size of each company in the visualisation reflects their research volume, helping you understand where to position your study.
    • Success Rates and Benchmarking: Visual cues, such as colours, indicate each company’s reported success rates, providing a clear benchmark for expected outcomes. You’ll see which trials succeeded and understand best practices that could benefit your protocol.
    • Potential Collaborations or Conflicts: Discover potential collaboration opportunities with non-competing entities, or assess overlapping research that may impact recruitment competition and trial visibility.
  5. Risk Mitigation
    Identify and strategise around common trial risks. Our platform highlights potential challenges such as patient dropout rates, recruitment delays, and site performance issues, offering proactive measures to address them.


Key Visual Insights in Our Full Report

Each full report includes customisable, interactive visuals, allowing you to:

  • Understand Research Trends: Quickly see how your trial fits within the broader research landscape and gauge your competitive position.
  • Communicate Trial Value: Use data-driven visual insights to present a compelling case to stakeholders, highlighting both your trial’s uniqueness and alignment with industry trends.
  • Optimise Trial Design Based on Competitive Insights: Tailor your trial design based on the success metrics and strategies of top-performing studies.

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Key Advantages of TrialKey’s Biostatistical Validation

Unmatched Data Precision

30+ Years of Global Trial Data
TrialKey processes vast datasets from both structured and unstructured sources, ensuring every insight is backed by historical trends, competitor data, and trial benchmarks.

AI-Powered Simulations for Protocol Success
We leverage machine learning to simulate trial outcomes, helping you refine endpoints, minimise risks, and design protocols with a high probability of success.

Real-Time Competitive Insights

Competitor Benchmarking
See how your trial design stacks up against competitors in the same therapeutic area, with comparisons on success probabilities and best practices.

Unstructured Data Analysis
Extract hidden insights from unstructured sources, including trial announcements and global registries, with NLP-driven analysis that traditional platforms miss.

Patient-Centric Trial Optimisation

Tailored Recruitment Strategies
Get targeted recommendations to reach the right patients faster. Our data-driven site and recruitment insights ensure your trial is on time and on budget.

Inclusion/Exclusion Criteria Refinement
Increase enrolment success with AI-driven adjustments to eligibility criteria, enhancing statistical power and reducing delays.

Transparent Process for Reliable Outcomes for Clinical Research Organisations

  • Protocol Review & Analysis
    Upon receiving your trial protocol or synopsis, our AI models pull relevant data from global registries, generating initial recommendations based on proven success factors.

  • Preliminary Report for RFP Success
    Within five business days, receive a success probability score, competitor insights, and data visuals to strengthen your proposal.

  • Comprehensive Data Collection
    Once the project is secured, we perform a full analysis of both structured and unstructured data, ensuring all critical insights are considered.

  • Detailed Full Report for Execution
    TrialKey delivers a comprehensive roadmap, covering site selection, recruitment, protocol optimisation, and competitor analysis to ensure a streamlined execution.

Benefits of TrialKey’s Compensation Model for CROs

  • Risk-Free Initial Engagement
    TrialKey’s free preliminary report gives CROs the confidence to evaluate the potential and precision of our advanced AI-powered tools before committing.
  • Transparent Pricing
    The fixed fee structure eliminates uncertainty, enabling CROs to budget effectively without hidden charges or unexpected expenses.
  • Streamlined Process
    Our invoicing and payment terms are designed for simplicity and efficiency, allowing CROs to focus on trial success rather than administrative burdens.
  • Adaptability for Decision-Making
    The non-funding clause empowers clients to explore TrialKey’s capabilities with no financial pressure, ensuring decisions are well-informed and data-driven.

Proven Compliance and Partnership Transparency

As a publicly listed company, Opyl follows strict ASX compliance standards, ensuring transparency in every partnership and major contract.

  • Customised ASX Announcements
    For each partnership, we create tailored ASX disclosures covering financial terms, project scope, and duration, ensuring all parties remain fully informed.

  • Collaborative Communications
    Key project updates are shared in standalone announcements or quarterly reports, based on the project scope and mutual agreement.

Partner with TrialKey Today

TrialKey is more than a feasibility tool – it’s a competitive advantage.

Our AI-powered biostatistical tools provide tailored insights, helping you validate your research question, determine sample sizes, and optimise study protocols for clarity, feasibility, and reliability.

Join the CROs transforming clinical trials with TrialKey.