ClinSmart
ClinSmart is a full-service Clinical Research Organization (CRO) dedicated to providing personalized, focused, and results-driven clinical trial services. With a wealth of experience across various therapeutic areas, ClinSmart leverages a global network and local presence to support clients in bringing new products to market efficiently and effectively. The company emphasizes trust, success, and a personal touch in every project, aiming to improve quality of life through innovative clinical research.
Industries
Nr. of Employees
small (1-50)
ClinSmart
Newtown, Pennsylvania, United States, North America
Patents
Controlled absorption water-soluble pharmaceutically active organic compound formulation for once-daily administration
US-11191719-B2
View DetailsControlled absorption water-soluble pharmaceutically active organic compound formulation for once-daily administration
US-10463611-B2
View Details
Controlled absorption water-soluble pharmaceutically active organic compound formulation for once-daily administration
US-11191719-B2
View DetailsControlled absorption water-soluble pharmaceutically active organic compound formulation for once-daily administration
US-10463611-B2
View DetailsServices
Design of clinical development plans and forecasting of program risks and probabilities of success to guide development decisions.
End-to-end clinical data operations including data collection, database design, data cleaning, interpretation and preparation for reporting.
Operational statistics, statistical analysis plans, programming and generation of statistical outputs for study reports and regulatory submissions.
Monitoring services including pre-study visits, initiation, routine on-site and remote monitoring, and close-out activities to ensure protocol adherence and GCP compliance.
Development of investigator brochures, protocols, informed consents, clinical study reports, regulatory summaries and scientific publications to support submissions and communication.
Support for preparation and submission of INDs and associated proof-of-concept study planning and interactions with regulatory authorities.
Design of clinical development plans and forecasting of program risks and probabilities of success to guide development decisions.
End-to-end clinical data operations including data collection, database design, data cleaning, interpretation and preparation for reporting.
Operational statistics, statistical analysis plans, programming and generation of statistical outputs for study reports and regulatory submissions.
Monitoring services including pre-study visits, initiation, routine on-site and remote monitoring, and close-out activities to ensure protocol adherence and GCP compliance.
Development of investigator brochures, protocols, informed consents, clinical study reports, regulatory summaries and scientific publications to support submissions and communication.
Support for preparation and submission of INDs and associated proof-of-concept study planning and interactions with regulatory authorities.
Expertise Areas
- Clinical trial management (Phase I–III and post-marketing)
- Clinical data management
- Biostatistics and statistical programming
- Regulatory submissions and IND preparation
Key Technologies
- Electronic data capture (EDC) systems
- CDISC SDTM data standard implementation
- eTMF (electronic Trial Master File) systems
- Predictive analytics for clinical development