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Clinical Trial Success Assurance

De-risking clinical trials with data, AI, and deep operational insight, saving costs and bringing innovative medicines to patients faster

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Refill of liquid on tubes, by Louis Reed.

Uncertainties and risks can derail clinical trial timelines, delaying market entries and delaying patients’ access to innovative medicines. With data from over one million clinical trials, advanced analytics and AI, Rewire’s Trial Success Assurance empowers clinical researchers to significantly reduce trial risks - from early planning through to execution stages.

A novel approach to clinical trial optimization grounded in big data and AI

Increasing medical complexity and requirements imposed by regulators are giving rise to unprecedented operational complexity. To serve the healthcare industry’s need for effective clinical trial design, Rewire entered a partnership with GoTrial, a platform that collects, harmonizes and curates clinical trial data from worldwide registries, building up a knowledge base of over 1 million clinical trials. Rewire’s Trial Success Assurance (TSA) presents a novel lever to optimize study design and execution with an objective assessment firmly grounded in big data.

TSA comes with a built-in option for risk-mitigation through our partner Munich Re

A growing number of clinical trial sponsors seek not only to reduce risk but also to transfer residual risk. In partnership with Munich Re, a global reinsurance and specialty insurance group, TSA provides options to insure against the risks of enrolment shortfalls. By combining unprecedented data, deep subject matter expertise and high-quality data science capabilities and AI with reliable insurance services our TSA product elevates clinical research and ensures trial timelines are met.

By combining unprecedented data, deep subject matter expertise and high-quality data science capabilities, we accelerate your clinical trial in an independent, data-driven way.

Discover how we can help

A modular approach tailored to your needs

Study health check

Deliver objective risk intelligence at the protocol and site level - empowering smarter and faster clinical trial setup, execution and adjustments of ongoing studies

Site optimization

Maximize enrolment success by identifying, prioritizing, and phasing clinical trial sites based on predicted performance, patient access, and competition risk

Protocol optimization

Optimize protocol feasibility and patient accessibility by simulating real-world impact of eligibility criteria, protocol burden, and recruitment complexity

Strategic monitoring

Enable real-time operational oversight and proactive risk management across enrolment, site performance, and competitive dynamics, ensuring trials stay on track throughout execution

Rewire your clinical trials with AI

TSA complements best practices with objective perspectives grounded in big data & advanced analytics

From execution to strategic assurance

Example: In one case, TSA identified that narrow eligibility of a study severely restricted the patient pool. Adjustments informed by data benchmarks expanded the patient pool by more than 40%.

From expert judgement to global data intelligence

Example: Based on data from over 1 million clinical studies and over 900 thousand site profiles, TSA flagged a high risk of under-enrolment in a multi-country trial after detecting that over 80% of planned sites were simultaneously involved in competing studies.

From static assumptions to dynamic simulation

Example: TSA compared a study protocol to 21 highly similar trials and showed protocol adjustments that could significantly reduce projected enrolment delays, enabling mitigation before study start.

From bespoke services to modular deployment

Example: A late-phase sponsor received a full TSA report of eligibility diagnostics, site risk scoring, and enrolment simulation within 6 weeks of submitting their protocol.

From operation planning tool to enabler of risk transfer

Example: Munich Re offers an enrolment performance insurance for clinical trials based on TSA outputs, marking a new frontier in how clinical trial risk can be managed.

Our track record speaks volumes

Rows of lab tubes sit in a tray. Photo by Nathan Rimoux on Unsplash.

40%

Increased patient pool

We identified overly complex and restrictive eligibility criteria that excluded patients who were likely to benefit from treatment in a study that struggled to find eligible patients.

25%

Enrolment target added

We suggested an optimized set of high-potential sites predicted to enrol a significant part of a study's target patients.

What if we could tap into the world’s largest knowledge base of clinical trials to turn study planning and execution into a predictable process, grounded in evidence?

We can.

Ask us how

Unlock the power of data & AI for your clinical studies today.

Get in touch.

Looking for an objective assessment of your clinical trial, powered by big data & AI?

Philipp M. Diesinger

Partner, Rewire DACH