Have confidence in your trial data
Our team of highly experienced scientists, physicians, and statisticians are involved throughout the study lifecycle, ensuring:
- Protocols and study designs contain the most suitable outcome assessments and data collection methodologies
- Data is regulatory-compliant
- Solutions are patient-centric and deliver high-quality data, whether collected remotely or at a study visit
Why involve Clario Science?
Clario is committed to ensuring that sponsors generate the data that their study needs. Involving our Scientists early on in the study lifecycle will enable clients to achieve the following:
Regulatory-compliant data
Enhanced patient retention, compliance and adherence
Increased patient safety
High-quality data
Improved site experience
Meet the team
Clario’s highly experienced Science Team consists of scientists, industry-recognized key opinion leaders (KOLs), physicians, regulatory specialists, statisticians, and solution and product designers.
- Industry Leaders – with expertise across a broad spectrum of therapeutic areas and indications
- Proactively engage with regulatory bodies
- Deliver Thought Leadership to advance outcome measurements
- Specialize in eCOA, Cardiac Safety, Respiratory, Imaging, and Precision Motion
Delivering value throughout the study lifecycle
Clario’s Science Team draws on experience and knowledge gained from over 19,000 studies across 560 indications in more than 100 countries – offering support at every stage of a trial. Below are a few selected examples of what we offer:
1. Outcome Assessment / Endpoint Strategy Consultation
- Early stage support to guide your Clinical Development Program:
- Gap analysis and instrument identification
- Supporting the choice of Primary/Secondary parameters
- Assessment on non-clinical cardiac safety data to help inform design of first in human study
2. Protocol Development
- Protocol review and recommendations for:
- Assessments
- Endpoints
- Device/modality selection
- Cardiac Inclusion/Exclusion and stopping criteria
- Custom instrumented test and/ or instruction design
3. Study Design
- Recommendations on:
- Device/modality selection & deployment
- Type and quantity of data for routine studies
- In-clinic vs remote assessment
- Read paradigm
- Strategies for enhanced patient engagement and compliance
4. Study Start-Up & Conduct
- Patient, site and rater training
- Feedback on data quality
- Independent radiology and oncology data reviews
- Selection of investigator notifications
- Data quality monitoring & study oversight
5. Close Out
- Review of study outcomes and results
- Data interpretation
- Statistical analysis and expert cardiac safety report
- Rapid database lock
- Guidance on next development phase/lifecycle opportunities
Our Regulatory Specialists are on hand throughout the lifecycle of a study, offering support with regulatory communications, submissions, evidence dossiers and much more.
19,000
studies
560
indications
100+
countries
5.2M
patients
Discover what Science can do for you
Email [email protected] to get in contact with our team of scientific experts.