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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.

Refill of liquid on tubes, by Louis Reed. Refill of liquid on tubes, by Louis Reed.

Our clients

Unmanaged risks such as insufficient site experience or overly strict participation criteria can derail clinical trial timelines, incurring lost revenues and delaying patients’ access to innovative medicines. With exclusive data from over one million clinical trials, advanced analytics and AI, our clinical trial success assurance empowers you to address and mitigate critical risks in clinical trials, from early planning through execution.

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

The amount of data collected in clinical trials and the requirements imposed by regulators are ever increasing, giving rise to an 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. Our Trial Success Assurance (TSA) presents a novel lever to optimize study design and execution with an objective assessment grounded in big data, complementing the approach of clinical research organizations that are grounded in networks of expertise and trust. 

Modular approach tailored to your needs

We designed TSA as a modular offering to provide fast access to initial diagnostics, and to deep dive into site selection, protocol optimization or operational oversight as and when needed. The study health check provides a holistic risk assessment of the study setup: Within 6 weeks following receipt of the study protocol and the planned sites, our expert team provides actionable insights into study design, protocol, inclusion/exclusion criteria, site selection and operational feasibility based on historic clinical study and site data. Our site optimization deep dive is based on historic site performance, epidemiology, demographics and available real-world patient data. It takes into account planned and ongoing competing trials and provides enrollment forecasts given the current and a suggested optimized set of study sites. Protocol diagnostics optimizes feasibility and patient accessibility by simulating the real-world impact of eligibility criteria, protocol burden, and recruitment complexity. Our strategic monitoring layer combines continuous monitoring of globally registered clinical trials for relevant competitive events, with the option to integrate with your clinical trial management system, empowering risk-based monitoring with predictive analytics and early warning alerts. 

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.

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 are 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 that can enrol a significant part of your 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

Implementing AI in clinical trials
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 enrollment, site performance, and competitive dynamics, ensuring trials stay on track throughout execution

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?

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Philipp M. Diesinger

Partner, Rewire DACH

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