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Quanticate - Clinical Research Organization

EXPERTISE

Rescue Study Clinical Research Organization (CRO)

Get your study back on track and set up for success, with our global team of biometric experts

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NAVIGATION

We understand that when a clinical trial encounters unexpected challenges, it can induce significant distress, which can jeopardize data integrity and study validity. Additional obsticles, such as regulatory compliance concerns, resource constraints, and technological issues, further contribute to trial complications. As experts on rescue studies in clinical trials, you're not just getting a service provider; you're gaining a partner committed to turning your clinical trial around, and sharing our expertise, as well as our knowledge. Our global team of specialists use a proactive and patient-centric approach tailored to your specific needs, to identify and tackles challenges swiftly. This ensures your research is resilient against unexpected setbacks moving forward, to get your study back on track and set up for success. 

Discover how Quanticate can help get your clinical trial back on the road to market success.

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The benefits of a Specialist Biometric CRO

  • Prompt and proactive planning: Early identification and resolution of challenges are crucial. Our team specializes in quickly developing strategic plans tailored to your study's unique needs.

  • Customized rescue operations: We know every trial is different. Our tailored rescue solutions are meticulously crafted after diving deep into the specifics of your study.

  • Versatility across therapeutic areas: Our extensive experience covers various therapeutic areas, giving us the insight and flexibility to handle even the most complex rescue scenarios.

  • Collaborative support and approval: We involve everyone in the rescue mission! A unified effort with cohesive team understanding and management buy-in is essential.
  • Resource optimization and financial prudence: Ensuring efficient resource allocation and budget management are fundamental to our approach to maintain a smooth transition without financial surprises.
  • Effective communication and vigilant monitoring: Transparent communication and regular check-ins are pillars of our methodology. We keep all parties informed and assess progress continuously to guarantee milestones are met.

Our Tailored Approach for Successful Trial Recovery

Identification of Issues

Determine the specific problems leading to the need for a rescue study, such as recruitment challenges, data quality issues, or logistical setbacks.

Stakeholder Meeting

Gather all stakeholders, including sponsors, clinical investigators, and regulatory bodies, to discuss the identified issues and potential solutions.

Plan Development

Develop a detailed rescue plan, including revised protocols, timelines, and budgets. This might involve changes to study design, additional training for staff, or the introduction of new technologies or methodologies.

Regulatory Approval

Submit the revised plan and any protocol amendments to the relevant ethical and regulatory bodies for approval.

Implementation

Roll out the rescue plan across all sites, ensuring consistent and thorough application of the new protocols and procedures.

Data Monitoring

Implement a robust data monitoring plan to allow for interim analysis and close tracking of the rescue study progress, ensuring adherence to the revised protocols and identifying any new issues promptly.

Data Management

Ensure that data management systems are capable of handling changes and that data integrity is maintained throughout the process.

Communication

Maintain open and regular communication with all stakeholders, including trial participants, throughout the rescue study to ensure transparency and trust.

Completion and Reporting

Upon completion of the rescue study, analyze the data, compare it with the original trial data, and prepare detailed reports for submission to regulatory bodies and publication.

Have a Clinical Trial Where Your Drug Efficacy is in Doubt?

Our experienced team of expert statisticians are on hand to step in, assess the situation and implement effective strategies to rescue studies facing difficulties. Request a consultation today to find out more on why you should choose Quanticate, the leading rescue studies CRO.

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Additional Resources

BLOG

This guide demonstrates how to reassess, revise & recover your clinical trial successfully with a rescue study, & the benefits of choosing the right CRO.

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BLOG

This paper reviews the different approaches to sourcing in clinical development. Quanticate is seeing a wide range of sourcing scenarios and this paper assesses these different strategies.

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