The Clinical Trial Protocol Challenge

Clinical trial protocols are becoming increasingly complex, causing significant delays and costs.

Protocol Complexity

Increasing complexity is creating bottlenecks in clinical trials

70%

Protocols requiring amendments

£350k

Average cost per amendment

3+

Months of delay per amendment

1000s

Of lives potentially affected

1

Complex Eligibility Criteria

Overly restrictive or ambiguous eligibility criteria lead to recruitment challenges and increased screen failures.

2

Costly Amendments

Over 70% of protocols undergo at least one substantial amendment, each costing an average of £350,000.

3

Trial Delays

Protocol complexity delays trials by up to three months, directly impacting patient access to potentially life-saving therapies.

Our Solution

AI-Powered Protocol Optimization

BioPace serves as an intelligent co-pilot for protocol development, helping you create clearer, more operationally feasible protocols before trials begin.

Complexity Analysis

Our advanced NLP and ML algorithms analyze draft protocols to identify high-complexity areas and quantify operational burden.

Risk Assessment

Flag potential risks to recruitment or compliance with data-driven insights that help you prevent issues before they arise.

Smart Suggestions

Receive interactive, explainable reports with data-driven suggestions for improvement while maintaining regulatory compliance.

Before BioPace

Complex Manual Process

Protocol design relies on manual checks and subjective reviews

Costly Amendments

70% of protocols require amendments costing £350,000 each

Trial Delays

Up to 3 months delay per amendment, affecting patient access

After BioPace

AI-Powered Intelligence

Automated analysis of complexity, operational burden & risk factors

Proactive Improvement

Data-driven recommendations before issues impact your trial

Faster Time to Market

Fewer amendments and delays, resulting in quicker treatment availability

How It Works

Streamlined Protocol Optimization

Our platform makes it easy to identify and resolve protocol issues before they impact your trial.

1

Upload Your Protocol

Simply upload your draft protocol document to our secure platform.

2

AI-Powered Analysis

Our algorithms analyze the protocol for complexity, inconsistencies, and operational challenges.

3

Interactive Report

Receive a detailed, interactive report highlighting specific issues and opportunities for improvement.

4

Implement & Iterate

Make informed revisions to your protocol based on our suggestions, and re-analyze as needed.

Protocol Analyzer Dashboard

Protocol Complexity Score

Updated 2 min ago
0 78% - High Complexity 100

Eligibility Criteria

12 issues detected

Procedural Burden

Medium-High

Amendment Risk

82%

Recruitment Impact

-34% estimated

Top Recommendations

  • 1

    Simplify inclusion criteria #3 and #7 to broaden eligible population

  • 2

    Reduce frequency of non-essential measurements in visit schedule

  • 3

    Clarify ambiguous language in study procedures section 4.2

Our Vision

Accelerating Medical Innovation

We're committed to helping pharmaceutical companies and CROs bring life-saving therapies to patients faster.

Patient Impact

Even modest time savings can have significant health impacts. Accelerating the availability of a cancer therapy by three months could translate to thousands of lives extended or improved.

Healthcare Crisis

Protocol complexity has become a silent crisis in global healthcare. Our goal is to address this bottleneck in the development of life-saving treatments through intelligent protocol optimization.

Inclusive Trials

Simplified protocols enhance the trial experience for both participants and healthcare professionals. By flagging overly restrictive eligibility criteria, we help make clinical trials more accessible and diverse.

Ready to optimize your clinical trial protocols?

Join us in our mission to accelerate medical innovation through smarter protocol design.

Get Started Today

Ready to Optimize Your Clinical Trial Protocols?

Contact us to learn more about how BioPace can help reduce protocol amendments, improve site engagement, and accelerate time-to-market.

Our Office

London, United Kingdom

UK-based HealthTech Startup

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