Agati Clinical Informatics
Provider of clinical data, regulatory publishing and clinical resource services for pharmaceutical, biotechnology and medical device customers. Offers global clinical staffing and functional service provision (FSP) models, clinical data management and standardization (CDISC), biostatistics and statistical programming, pharmacovigilance, medical writing, regulatory submission publishing and clinical software development with onshore/nearshore/offshore delivery.
Industries
Nr. of Employees
large (251-1000)
Agati Clinical Informatics
Frisco, Texas, United States, North America
Products
SubmitBot
Software tool to automate regulatory submission package creation in eCTD structure, offering PDF conversion/editing, study tagging file creation, module reuse library and an integrated document management module.
SubmitBot
Software tool to automate regulatory submission package creation in eCTD structure, offering PDF conversion/editing, study tagging file creation, module reuse library and an integrated document management module.
Services
Clinical resource solutions (staffing)
Sourcing and placement of clinical operations personnel and functional teams for sponsor and CRO programs with flexible engagement models.
Clinical data management
End-to-end data management services across commercial EDC platforms and bespoke systems including quality control and process recommendations.
CDISC data standardization and metadata services
Metadata-driven conversion and mapping to CDISC SDTM and ADaM, CRF annotation, define.xml creation and development of reviewer guides.
Biostatistics and statistical programming
Statistical input to protocol development, sample size calculation, ADaM dataset generation, TLF programming, PK/PD analysis and interim/statistical analysis for trials.
Regulatory submissions publishing and labeling/artwork services
Compilation, formatting and lifecycle management for regulatory submissions (CTD/eCTD/IND/NDA/BLA/MAA/ANDA), eSubmissions setup, SPL creation and labeling lifecycle support.
Pharmacovigilance (PV KPO)
End-to-end adverse event case handling, periodic safety reporting (DSUR/PSUR/PADER), literature surveillance and database reconciliation with 24x7 coverage across global delivery locations.
Clinical resource solutions (staffing)
Sourcing and placement of clinical operations personnel and functional teams for sponsor and CRO programs with flexible engagement models.
Clinical data management
End-to-end data management services across commercial EDC platforms and bespoke systems including quality control and process recommendations.
CDISC data standardization and metadata services
Metadata-driven conversion and mapping to CDISC SDTM and ADaM, CRF annotation, define.xml creation and development of reviewer guides.
Biostatistics and statistical programming
Statistical input to protocol development, sample size calculation, ADaM dataset generation, TLF programming, PK/PD analysis and interim/statistical analysis for trials.
Regulatory submissions publishing and labeling/artwork services
Compilation, formatting and lifecycle management for regulatory submissions (CTD/eCTD/IND/NDA/BLA/MAA/ANDA), eSubmissions setup, SPL creation and labeling lifecycle support.
Pharmacovigilance (PV KPO)
End-to-end adverse event case handling, periodic safety reporting (DSUR/PSUR/PADER), literature surveillance and database reconciliation with 24x7 coverage across global delivery locations.
Expertise Areas
- Clinical trial management and staffing
- Clinical data management
- CDISC data standards and data standardization
- Biostatistics and statistical programming
Key Technologies
- CDISC standards (SDTM, ADaM)
- eCTD and eSubmissions standards
- Electronic Data Capture (EDC) platforms
- Statistical programming (SAS and equivalent tools)