Clinical Research - Agaram Technologies




Clinical Research

Clinical Research is crucial in the study of drugs that are supposed to reach the market right from pre-clinical through all the phases I- IV. Being subject to regulatory compliance it is indispensable for them to have flawless processes and data with high level of integrity in place.

QuaLIS Clinical Trial Management App collection helps the industry right from pre-clinical through all the phases of clinical trial management. The solution includes a clinical LIS for volunteer screening and testing.

InterFACER the clinical instrument interface middleware is deployed for interfacing clinical instruments. A volunteer database management system including biometric identification and screening handles the volunteers for clinical studies. A study protocol configuration module helps in creating studies.

A dynamic user modifiable CRF module helps in creating various templates for study recording. Phlebotomy, dietary, vitals recording, sample processing and storage are completely handled by the system. The Bio-availability/Bio-Equivalence (BA/BE) module handles the receipt of sample into storage freezers.

Lims Software, Lab Management Software, SDMS Software, ELN Software, Laboratory Management Software

Studies are conducted on the samples on LC-MS, ICP-MS, HPLCand UPLC with automated preparation of sequences for such instruments. Receiving validated results from instruments through the ELN is a highlight of our solution.

QuaLIS® Clinical Research Highlights Volunteer database management with biometric identification Volunteer screening Clinical Pathology LIS InterFACER® middleware for clinical instrument interface For study: Protocol generation of schedule Protocol document creation & management Conducting and recording (phlebotomy, dietary, vitals, CRF) Others 21 CFR Part 11 compliance Sample storage & shipping Sample receipt in BA/BE lab. Batch creation for LC-MS or other instruments ELN based results capture, review, validation and approval

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