Trials large and small benefit from Clario scientists
Collect data that’s meaningful, accurate and higher quality when you engage our teams early in your trial planning.
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Cardiac Safety
Clario scientists have an intimate knowledge of the regulatory landscape and actively participate in shaping guidelines through committee membership and study support. In particular, Clario sponsored the pivotal IQ-CSRC study, which demonstrated the efficacy of the exposure-response analysis as a replacement for the Thorough QT (TQT) study and directly contributed to shaping the December 2015 ICH E14 regulatory guideline revisions.
Dr. Borje Darpo’s extensive representation of the European pharmaceutical industry on the ICH E14 working group further enhances Clario’s regulatory expertise in cardiac safety revisions.
Choosing Clario scientists to optimize your clinical trial protocol ensures that you have access to the best scientific expertise available – helping minimize risk and maximize data accuracy.
ECG
Clario boasts a proven track record of expertise in cardiac safety, particularly in the field of centralized ECG. Our experience in cardiac safety spans over 50 years, having carried out more Phase I studies than any other ECG core lab.
Highly accurate, centralized ECG has the potential to improve enrollment rates by preventing patients from being unnecessarily excluded, which can happen up to 45% of the time with standard site-based ECG.
- Centralized ECG reduces false positive QT signals by ensuring accurate measurement at baseline to avoid misleading results when participants later show a normal QT.
- It also minimizes patient interruptions, as 77% of dosing interruptions have been found to be erroneous, meaning that patients may have stopped a potentially helpful treatment unnecessarily.
- Moreover, manual entry of ECG data can cause delays in interpretation, leading to potentially harmful delays in patient care.
Early Precision QT (EPQT)
Clario offers the proprietary Early Precision QT (EPQT) methodology, which serves to mitigate the sponsor’s risk and reduce trial costs by assessing the potential for QT prolongation in Firstin- Human studies and increasing the probability of obtaining a TQT waiver.
- As the only clinically validated approach to evaluating the QT safety of a drug in Phase I, the implementation of EPQT saves millions of dollars that are typically associated with conducting a TQT study.
- Additionally, EPQT allows for the collection of earlier go/no-go information during Phase I trials and facilitates the analysis of ten times more data than conventional approaches.
- Furthermore, the use of EPQT methodology serves to reduce QT variability.
Blood pressure
The updated regulatory guidance on the “Pressor Effect” brings increased scrutiny to the assessment of blood pressure during clinical trials, thereby increasing the demand for specialized expertise in this domain. Our scientists are well-regarded thought leaders in the evolving area of blood pressure and are adept at helping sponsors address these new regulatory challenges, especially for chronically administered drugs or those targeting obese patients.
Spotlight on oncology
Oncologic drugs have been known to elicit cardiovascular side effects, ranging from mild to severe, necessitating the need for thorough and rigorous cardiac safety evaluation. Unlike many other drugs, most oncology drugs cannot be safely administered to healthy volunteers, therefore making comprehensive QT risk analysis a challenge. For this reason, partnering with a scientific team that has a wealth of knowledge and experience in assessing cardiac safety risk for challenging drugs can be particularly critical.
eCOA
By partnering with Clario’s eCOA scientists, clinical trial sponsors and CROs can experience significant benefits such as improved eCOA strategy, optimized clinical outcome assessments and study design leading to enhanced patient engagement and data quality, reduced costs and site burden. Our science team reviews and recommends optimal data capture methodologies for trial and development programs, including the use of mobile devices, wearables and other emerging technologies, which can enhance data accuracy and patient convenience.
Rater training and participant and caregiver training can also be developed, with a focus on patient centricity and data quality. In doing so, Clario not only helps ensure compliance with regulatory requirements, but also helps site personnel understand the crucial role patient engagement plays in achieving trial objectives. Additionally, this training gives participants and caregivers a clear understanding of their responsibilities and obligations throughout the study.
Rater training and participant and caregiver training
Clario’s rater and participant and caregiver training draws on more than 20 years of eCOA expertise, training more than 60,000 clinical site raters and more than 100,000 participants and caregivers. We provide one system for training and eCOA, on-demand 24/7 access and a waiver system for qualified raters. This ensures standardized, flexible training that minimizes errors and data variability to meet regulatory guidelines for enhanced data quality and operational efficiency, while reducing site burden and improving patient understanding.
Suicide ideation and behavior monitoring (eC-SSRS and C-SSRS)
Clario holds exclusive rights to both the eC-SSRS and C-SSRS rating scales for clinical trials, which are recommended by the FDA for monitoring suicidal ideation and behavior (SIB) in trials, particularly in cases where the FDA requires SIB monitoring for specific drugs. The eC-SSRS enables patients to self-report, resulting in more honest and accurate responses. A clinician-reported C-SSRS is also available.
Spotlight on oncology
Clario possesses significant experience in providing eCOA support for Oncology clinical trials and can aid in ensuring compliance with regulatory guidelines that place greater emphasis on comprehending a drug’s impact on patient wellbeing and quality of life, which is particularly important in a highly competitive market where PROs can help differentiate a drug.
Medical Imaging
With more than 4,200 studies supported and over three million images processed across 29 imaging modalities, Clario’s global team of dedicated medical imaging experts and world-renowned key opinion leaders (KOLs) can help ensure your trial’s success.
Our Medical Imaging in clinical trials is unparalleled. From electronic image transfer to independent analysis, we offer a secure and comprehensive solution for your clinical trial imaging needs. Our clinical trial radiology services and imaging technology are data privacy compliant and enable easy electronic image submission – all within a streamlined, fully integrated process.
Regulatory and scientific expertise
Not every imaging core lab ensures your success and productivity as well as Clario does.
- Working with our scientists mean:
- More than 30 years of experience and process knowledge supporting thousands of clinical trials.
- Experience with all imaging modalities and major therapeutic areas.
- Expertise with protocol design and regulatory submission strategies.
- Network of experienced on-staff physicians and therapeutically aligned specialists providing expert independent image review.
- Worldwide regulatory agency experience.
Artificial intelligence (AI) and machine learning
By leveraging AI and prediction models in imaging clinical trials you can empower staff and medical experts alike to carry out their jobs faster and more effectively by enforcing regulatory compliance, reducing patient and privacy risks and avoiding fines and liability from potential data breaches by redacting sensitive patient identifiers.
With Image RedactAI, our industry-leading clinical trial privacy redaction software pairs AI-driven de-identification with expert human oversight of a quality control (QC) team to help you comply with 21 CFR Part 11, EU GDPR and other privacy regulations for images and videos.
Access peer-to-peer feedback and scientific discussion across all therapeutic areas
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Respiratory
The respiratory scientific team at Clario has made significant contributions to the field of spirometry, having been involved in the establishment of the 2019 ATS/ERS spirometry guidelines. These guidelines serve as the standard within the industry and provide a comprehensive framework for a successful spirometry test.
However, integrating these updated guidelines into clinical trials can be a challenge, particularly for experienced clinicians who may be accustomed to prior approaches. Many of our experts have spent years helping patients and participants perform spirometry maneuvers and understand the challenges faced by clinicians, and this provides a distinct advantage in training sites on how to meet the guidelines. Our ability to effectively navigate these challenges can lead to improved data quality, increased patient safety and enhanced trial outcomes.
Variability reduction
Clario has established its position as a frontrunner in addressing data variability in respiratory trials. With more than 50 years of expertise in respiratory trials, our scientists routinely share techniques and strategies for mitigating variability in various forums.
Non-respiratory indications
Clario’s scope extends beyond respiratory indications to encompass non-respiratory areas where lung safety data is increasingly important. Some non-respiratory indications may present respiratory symptoms, or some drugs for non-respiratory indications may elicit respiratory side-effects. There is also an increasing trend in the use of pulmonary-delivered drugs for non-respiratory indications, which requires demonstration that the drug does not compromise lung function. By leveraging our scientists, sponsors can benefit from a comprehensive approach to safety monitoring that encompasses both the targeted indication and any potential respiratory risks.
Clinical Adjudication
Clario’s Clinical Adjudication Solution combines the people and technology you need to overcome the challenges associated with data collection, de-identification, project management and 3rd-party adjudication platforms. Clario’s award-winning adjudication solution is the fastest-growing adjudication solution in the industry. Our proven combination of project management, medical expertise and advanced, cloud-based technology is why we have been a trusted partner for nearly 100 rescue studies.
We provide:
- Experienced project managers assigned to your project who can facilitate global trials.
- Dedicated country and local language support.
- A team to assist with adjudicator selection and committee management.
- Expert guidance on charter design by our veteran adjudication specialists and clinicians.
- Nurses and medical writers who can work with project managers to ensure your study is consistent with charter requirements.
- Resources who can manage queries and committee member worklists, as well as coordinate Clinical Events Committee (CEC) meetings globally for remote collaboration to ensure timely consensus.
Precision Motion
Clario’s Precision Motion scientific team of eight industry experts provides proactive guidance throughout the study lifecycle, enabling the generation of the richest evidence at every step. Our scientists offer a range of consulting services to accelerate trial timelines with tailored advice, data analysis and result interpretation. They also develop novel instrumented tests and endpoint measurements across therapeutic areas and trial formats, working alongside clients to accomplish more in less time.
- Protocol development and analysis planning
- Custom development and data analysis
- Study team support
Stay ahead in the evolving landscape of clinical research
Request a free initial consultation with our scientists.