Oasis Clinical Trials
GCP-Compliant Trial Management
From Protocol to Regulatory Submission
Oasis Clinical Trials manages the full lifecycle of clinical studies — protocol setup, site activation, subject randomisation, electronic case report forms (eCRF), safety monitoring, and regulatory submission packages. Integration with OasisLIMS lets laboratory sample tracking and bioanalytical data flow directly into clinical records, eliminating manual transcription across Phase I–IV studies.
Key Features
Protocol Management
Study protocol config with version control & amendments.
Subject Enrolment
Randomisation, screening, eligibility & demographics.
eCRF / EDC
Electronic data capture with edit checks & queries.
Adverse Event Reporting
SAE/AE capture, causality & MedDRA-coded reporting.
Sample Tracking
Collection, chain of custody & LIMS-linked results.
Regulatory Submissions
CTD/eCTD assembly for IND, NDA & ANDA.
Site Management
Multi-site coordination & investigator profiles.
Audit Trail
21 CFR Part 11 audit trails for all data changes.
Study Reports
Deviation summaries, enrolment status & safety listings.
Why Oasis Clinical Trials
End-to-End GCP
Protocol to submission in one compliant system.
Fewer Errors
eCRF edit checks & no manual data transfer.
Safety First
SAE/AE capture with MedDRA coding.
Submission-Ready
CTD/eCTD document assembly support.