Double-Blind Sample Randomization & Chain of Custody
Automate barcode generation and blind sample coding for clinical BA/BE trials, tracking freezer storage (-80°C), thaw cycles, and extraction plates.
CRO & Bioanalytical Informatics
Bioanalytical LIMS & BA/BE Study Automation for CROs
GCP/GLP compliant sample tracking, double-blind randomization, PK calculations, and automated regulatory dossiers.
Contract Research Organizations and bioanalytical laboratories require strict double-blind randomization, multi-timepoint sample custody tracking, and instant chromatographic assay ingestion. Novaqis LIMS delivers a 21 CFR Part 11 compliant bioanalytical platform with zero per-analyst seat taxes.
- GCP & GLP Validated
- 21 CFR Part 11 Compliant
- Double-Blind PK Ready
- Multi-Sponsor Isolated
Capabilities
What you get
Direct LC-MS/MS & Chromatography Interfacing
Ingest analytical sequences directly from Waters MassLynx, Sciex Analyst, and Thermo Chromeleon with automated calibration curve fitting (1/x² weighting).
Automated Pharmacokinetic (PK) Calculations & Reporting
Calculate Cmax, Tmax, AUC0-t, and AUC0-∞ with double-blind verification and generate ready-to-submit regulatory study dossiers in seconds.
Compliance & control
Built for regulated operations
Audit trails, electronic signatures, role-based access, and deployment choices designed for GxP validation, not bolted on after the fact.
CapabilityHow Novaqis delivers it
- Chain of Custody Barcoding
Tracks freeze-thaw cycles, aliquot splits, and storage locations with immutable timestamps.
- Calibration Curve Regression
Automated linear and quadratic regression analysis with automated acceptance criteria checking.
- AuditLens Inspection Room Mode
Single-click export of complete bioanalytical study audit packages for US FDA and DCGI audits.
Outcomes
Why teams choose Novaqis
- 100% GCP / GLP and 21 CFR Part 11 regulatory compliance
- Elimination of manual LC-MS/MS data transcription errors
- Multi-sponsor data segregation and secure sponsor portals
- Unlimited bioanalytical analysts on enterprise site licensing
FAQ
Frequently asked questions
- Novaqis LIMS provides purpose-built modules for BA/BE clinical studies, double-blind sample randomization, LC-MS/MS data acquisition, pharmacokinetic parameter calculation, and secure multi-sponsor data isolation.