Accelerate your clinical trial from initiation to implementation
Discover the major timesaving impact our latest tools, technology and Science team can have on your overall study timelines in our upcoming webinar.
About the webinar
New options for TQT waivers from First-in-Human and Oncology Phase I studies that can accelerate your clinical trials.
What you will learn:
- Look at how the new guidance can make TQT waivers more accessible for typical drugs
- Follow the journey of several drug candidates leveraging early phase QT assessment
- Examine QT assessment for oncologics and the impact of the new guidance
Helping to fast-track your timeliness across all endpoints
Whether you’re running a trial that includes cardiac safety, eCOA/ePRO, respiratory or imaging, Clario’s Science and Operational teams can advise on how to advance your trial forward, including:
Ensure your trial meets IRB submission and FPI dates with Clario’s latest tools and technology that speed up eCOA setup times:
- eCOA Customer Charter: Decrease the time needed to review and approve the Protocol Design Specification (PDS) process by 50% with our new simplified Customer Charter that uses accessible, easy-to-read language.
- Translation workbench: Expedite deployment in multiple countries and manage translation requests, responses and Quality Assurance (QA) with 20-30% faster translation timelines. Enhanced translation quality means patients have access to timely and accurate translations of their eCOA assessments.
- Custom to configurable study build: Save time in study build for all types of studies thanks to our configurable eCOA model that makes it easy to set up, adapt, build and visualize study designs – all while reducing human error.
- Extensive standardized assessment library: A library of pre-built and pre-validated assessments is ready for immediate deployment, as are thousands of customer-specific assessments to help you meet patient-reported outcome goals with minimal or no modifications.
Shave off months in your study timeline by determining the cardiac safety risk of your compound in Phase I with Clario EPQT:
- Developed with regulators and leading industry experts, EPQT is the only clinically validated approach to determine the clinical safety of a compound in Phase I.
- Knowing QT risk earlier enables you to prioritize your development pipeline and make more confident go/no-go decisions of your compound.
- 10x more data analyzed than conventional methods means increased data quality and more precise QT assessments, helping eliminate the need for unnecessary late-stage TQT studies.
Access expertise across therapeutic areas, endpoint technologies, regulatory, safety and patient engagement throughout the duration of your trial. Our world-renowned Science teams:
- Are involved early on for correct endpoint identification, including any associated digital and trial design strategies that support flexible trial design for decentralized trials (DCTs) and adaptive, seamless design trials.
- Work with sponsors and sites to oversee qualitative and quantitative endpoints so high-quality data can be collected for eligibility, safety and efficacy studies.
- Provide expert independent protocol review, data analysis and maximum trial efficiency in support of regulatory approval for drugs, therapies and medical devices.
- Incorporate the latest developments in clinical research and regulatory compliance, and contribute to the advancement of industry outcome measures.
- Provide strategies and best practices for instrument design that improve the quality of data and the digital patient journey.
- Collaborate with Clario’s experienced logistics teams and local logistics hubs in the US, UK, EU and APAC to keep your trial running smoothly.
Ensure your trial meets IRB submission and FPI dates with Clario’s latest tools and technology that speed up eCOA setup times:
- eCOA Customer Charter: Decrease the time needed to review and approve the Protocol Design Specification (PDS) process by 50% with our new simplified Customer Charter that uses accessible, easy-to-read language.
- Translation workbench: Expedite deployment in multiple countries and manage translation requests, responses and Quality Assurance (QA) with 20-30% faster translation timelines. Enhanced translation quality means patients have access to timely and accurate translations of their eCOA assessments.
- Custom to configurable study build: Save time in study build for all types of studies thanks to our configurable eCOA model that makes it easy to set up, adapt, build and visualize study designs – all while reducing human error.
- Extensive standardized assessment library: A library of pre-built and pre-validated assessments is ready for immediate deployment, as are thousands of customer-specific assessments to help you meet patient-reported outcome goals with minimal or no modifications.
Shave off months in your study timeline by determining the cardiac safety risk of your compound in Phase I with Clario EPQT:
- Developed with regulators and leading industry experts, EPQT is the only clinically validated approach to determine the clinical safety of a compound in Phase I.
- Knowing QT risk earlier enables you to prioritize your development pipeline and make more confident go/no-go decisions of your compound.
- 10x more data analyzed than conventional methods means increased data quality and more precise QT assessments, helping eliminate the need for unnecessary late-stage TQT studies.
Access expertise across therapeutic areas, endpoint technologies, regulatory, safety and patient engagement throughout the duration of your trial. Our world-renowned Science teams:
- Are involved early on for correct endpoint identification, including any associated digital and trial design strategies that support flexible trial design for decentralized trials (DCTs) and adaptive, seamless design trials.
- Work with sponsors and sites to oversee qualitative and quantitative endpoints so high-quality data can be collected for eligibility, safety and efficacy studies.
- Provide expert independent protocol review, data analysis and maximum trial efficiency in support of regulatory approval for drugs, therapies and medical devices.
- Incorporate the latest developments in clinical research and regulatory compliance, and contribute to the advancement of industry outcome measures.
- Provide strategies and best practices for instrument design that improve the quality of data and the digital patient journey.
- Collaborate with Clario’s experienced logistics teams and local logistics hubs in the US, UK, EU and APAC to keep your trial running smoothly.
Solutions you can trust
Successful trials demand proven solutions that deliver confidence at each pivotal moment.
1,000+
the number of potential medicines tested using Clario remote data collection technologies
60%
of all FDA drug approvals in the last five years came from Clario-supported studies
50 years
of Clario’s clinical, global regulatory and therapeutic experience
21,000+
clinical trials spanning more than five million patients in 120 countries
24/7
local support troubleshoots and finds answers to all your questions while reducing site and management burden
Time is of the essence. Let's start accelerating your trial today.
Accurate study data, captured right the first time
As a trusted eCOA provider to over 4,000 studies, our experienced scientists, physicians and statisticians ensure your trial includes only the most suitable outcome assessments and data collection methodologies, resulting in:
High-quality data that leads to operational efficiencies and reduced sample sizes for a shorter trial duration overall
Regulatory-compliant, endpoint data that can be collected remotely or at study visits
Patient-centric solutions that drive engagement and retention