Target Health Inc.
Target Health is a New York City–based full-service contract research organization (CRO) and clinical trials software provider. The organization offers regulatory affairs, clinical trial management (Phase I–IV), data management and biostatistics, medical and regulatory writing, pharmacovigilance/safety services, and a suite of cloud-based clinical software for electronic data capture, eSource, document management, medical coding, randomization/IMP management, and eConsent. The company also describes GDPR and privacy compliance efforts and provides eCTD publishing and submission operations.
Industries
Nr. of Employees
medium (51-250)
Target Health Inc.
New York, New York, United States, North America
Products
EDC / eSource and study builder platform
Cloud-based electronic data capture and eSource platform supporting study build, edit checks, role-based access, CRF customization, eConsent, ePRO and data exports (including SAS datasets).
Safety data management system
Web-based adverse event and safety database with workflows for case entry, review, electronic signoff and regulatory reporting (E2B R3, CIOMS, MedWatch).
Web-based document management (eTMF) system
Secure, browser-based document repository with versioning, electronic signatures, routing, audit trails and timed access control to support regulatory and study document management.
Medical coding tool
Web-based encoder to map CRF terms to MedDRA and WHODRUG with a user-defined dictionary and reporting outputs.
EDC / eSource and study builder platform
Cloud-based electronic data capture and eSource platform supporting study build, edit checks, role-based access, CRF customization, eConsent, ePRO and data exports (including SAS datasets).
Safety data management system
Web-based adverse event and safety database with workflows for case entry, review, electronic signoff and regulatory reporting (E2B R3, CIOMS, MedWatch).
Web-based document management (eTMF) system
Secure, browser-based document repository with versioning, electronic signatures, routing, audit trails and timed access control to support regulatory and study document management.
Medical coding tool
Web-based encoder to map CRF terms to MedDRA and WHODRUG with a user-defined dictionary and reporting outputs.
Services
Regulatory strategy, preparation and filing support across drugs, biologics, devices and combination products; eCTD publishing and submission project management.
End-to-end study management including project management, monitoring (on-site and remote), DSMB support, and risk-based monitoring implementation.
Data management operations, external data integration, medical coding, CDISC mapping and statistical analysis and programming using SAS.
Preparation of protocols, clinical study reports, investigator brochures, informed consent forms, and other scientific and regulatory documents.
Regulatory strategy, preparation and filing support across drugs, biologics, devices and combination products; eCTD publishing and submission project management.
End-to-end study management including project management, monitoring (on-site and remote), DSMB support, and risk-based monitoring implementation.
Data management operations, external data integration, medical coding, CDISC mapping and statistical analysis and programming using SAS.
Preparation of protocols, clinical study reports, investigator brochures, informed consent forms, and other scientific and regulatory documents.
Expertise Areas
- Clinical trial management (Phase I–IV)
- Electronic data capture and eSource-enabled trials
- Regulatory strategy and electronic submissions (eCTD)
- Data management and CDISC SDTM mapping
Key Technologies
- Cloud-based EDC / eSource platforms
- Electronic informed consent (eConsent)
- ePRO / mobile data capture
- IRT / IWRS randomization and IMP management
News & Updates
The company states a 100% success rate for certain market applications (e.g., NDA, BLA, 510(k), de novo, PMA) and prior-approval FDA inspections at its offices.
The company states a 100% success rate for certain market applications (e.g., NDA, BLA, 510(k), de novo, PMA) and prior-approval FDA inspections at its offices.