Dt&SanoMedics
South Korea–based contract research organization providing integrated clinical research services across phases and therapeutic areas. Services described include clinical operations, data management and CDISC compliance, biostatistics and statistical programming, pharmacovigilance, regulatory consulting and medical writing, medical device clinical trial support, quality assurance/GCP audits, and software solutions for clinical trials. The organization positions itself as part of a broader bio group offering preclinical analysis, pharmacokinetic/toxicokinetic testing and one-stop CRO services from preclinical to real-world evidence (RWE).
Industries
Nr. of Employees
small (1-50)
Dt&SanoMedics
Products
Clinical Operation Services
Comprehensive clinical trial support services including site feasibility, study initiation, monitoring, site management, and regulatory document review to ensure quality and accuracy of clinical studies.
Medical Device Clinical Trial
Full-service clinical trial support for medical devices throughout their development life cycle, ensuring timely project delivery with expertise across therapeutic areas.
Protein Characterization
Service for characterizing proteins in research and clinical studies.
Toxicokinetic Analysis
Service for analyzing toxicokinetics in clinical and preclinical studies.
Pharmacokinetic Analysis
Service for pharmacokinetic analysis in clinical research.
Unique Convergence System
A unique convergence service platform for drug development from pre-clinical trial to real-world evidence (RWE) using IT technology, offered by Dt&SanoMedics, the first ASIA CRO capable of conducting pre-clinical trials, bioequivalence tests, and clinical trials in parallel or simultaneously.
Clinical Operation Services
Comprehensive clinical trial support services including site feasibility, study initiation, monitoring, site management, and regulatory document review to ensure quality and accuracy of clinical studies.
Medical Device Clinical Trial
Full-service clinical trial support for medical devices throughout their development life cycle, ensuring timely project delivery with expertise across therapeutic areas.
Protein Characterization
Service for characterizing proteins in research and clinical studies.
Toxicokinetic Analysis
Service for analyzing toxicokinetics in clinical and preclinical studies.
Pharmacokinetic Analysis
Service for pharmacokinetic analysis in clinical research.
Unique Convergence System
A unique convergence service platform for drug development from pre-clinical trial to real-world evidence (RWE) using IT technology, offered by Dt&SanoMedics, the first ASIA CRO capable of conducting pre-clinical trials, bioequivalence tests, and clinical trials in parallel or simultaneously.
Services
Regulatory strategy, market access planning, pre-IND consulting, dossier preparation (eCTD), agency interaction and CTD/module writing across pharmaceuticals, biologics and devices.
Site feasibility, initiation, monitoring, management, source document review, investigational product accountability and study close-out services for clinical trials.
CRF/eCRF design, data validation plans, EDC setup and operation, medical coding, database quality checks, database lock and CDISC SDTM/ADaM conversions.
Study design consulting, sample size and power calculations, randomization services, SAP development, interim/final statistical reporting and ADaM-compliant analysis dataset generation.
Safety monitoring for clinical trials and post-marketing, SAE handling, PSUR/DSUR and RMP preparation, PV audits and region-specific PV compliance support.
Preparation and review of protocols, investigator brochures, informed consent forms, clinical study reports, regulatory submissions and scientific publications.
Regulatory strategy, market access planning, pre-IND consulting, dossier preparation (eCTD), agency interaction and CTD/module writing across pharmaceuticals, biologics and devices.
Site feasibility, initiation, monitoring, management, source document review, investigational product accountability and study close-out services for clinical trials.
CRF/eCRF design, data validation plans, EDC setup and operation, medical coding, database quality checks, database lock and CDISC SDTM/ADaM conversions.
Study design consulting, sample size and power calculations, randomization services, SAP development, interim/final statistical reporting and ADaM-compliant analysis dataset generation.
Safety monitoring for clinical trials and post-marketing, SAE handling, PSUR/DSUR and RMP preparation, PV audits and region-specific PV compliance support.
Preparation and review of protocols, investigator brochures, informed consent forms, clinical study reports, regulatory submissions and scientific publications.
Expertise Areas
- Clinical trial management
- Clinical data management and CDISC implementation
- Biostatistics and statistical programming
- Pharmacovigilance and safety monitoring
Key Technologies
- Electronic data capture (EDC)
- Clinical trial management systems (CTMS)
- Electronic TMF and e-signature
- CDISC standards (SDTM, ADaM)
News & Updates
Announcement that the organization obtained ISO 14155 certification for medical device clinical trial operations.
Report of a collaboration agreement with a therapeutics company to co-develop a biologic/bio-better for refractory gout.
Press coverage describing organizational growth and positioning in the CRO sector amid increased interest in therapeutics development.
Announcement that the organization obtained ISO 14155 certification for medical device clinical trial operations.
Report of a collaboration agreement with a therapeutics company to co-develop a biologic/bio-better for refractory gout.
Press coverage describing organizational growth and positioning in the CRO sector amid increased interest in therapeutics development.