Services

 

Pre study investigation visit

 

To conduct before initiation of clinical study to ensure pre study aarangements and verify documents required to be filled before conduct of study.


In process clinical monitroring

 

We visit CRO as per schedule and monitor check in day, dosing day and check out day activities and fulfill Sponsor's obligation to monitor ongoing study and monitor Inform consent presentation, consent taking process, eligibility tests, compliance of Inclusion/Exclusion criteria, selection of subjects, dispensing and check in of subjects to clinic, dosing, safety monitoring, blood sample collection as per time points, separation of biological matrix, strorage, adverse event (if any) to ensure protocol compliance and safety and wellbeing of participated subjects.


Retrospective Clinical Monitoring

 

After competion of study and verify reported trail data are accurate, complete, and verifiable from source documents. Review Trial Master File, Subject wise Case Report Forms, Informed Consent Forms, Medical Screening Records and other study related documents.


In process Bioanalytical Monitoring

 

Samples retrieval, restorage process, Sample preparation as per extraction procedure, Labeling of polypropylene tubes and vials, sample batch organization & sequence sheet verification, samples loading and raw data check up of subject's sample analysis, method validation.


Retrospective Bioanalytical Monitoring

 

Draft bioanalytical verification report verification with raw data, repeat analysis documents, Incurred sample reanalysis values, batch failure investigation review (if any), chromatograms review and study related raw data monitoring.