Pharma
The pharmaceutical industry faces mounting pressure to bring drugs to market faster while maintaining rigorous quality and compliance standards. Quorium provides digital solutions that streamline R&D, manufacturing, and supply chain operations across the pharma value chain.
R&D Data Management & Informatics
We build laboratory information management systems (LIMS) and electronic lab notebooks (ELN) that centralize experimental data, samples, and protocols. Our platforms support FAIR data principles and integrate with analytical instruments and high-throughput screening systems.
Data pipelines we develop automate the ingestion, normalization, and analysis of assay results, enabling researchers to draw insights faster and reduce the time from target identification to lead optimization.
GMP & FDA Compliance Systems
Quorium develops computerized systems that comply with 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines. Our solutions include electronic signatures, audit trails, user access controls, and data integrity checks that satisfy regulatory inspectors.
We support validation lifecycles including IQ, OQ, PQ protocols and maintain validation documentation packages that stand up to FDA, EMA, and MHRA inspections.
Clinical Trial Management & Automation
We build clinical trial management systems (CTMS) and electronic data capture (EDC) platforms that streamline study startup, patient enrollment, data collection, and site monitoring. Our systems support CDISC SDTM and ADaM data standards for regulatory submission readiness.
Automation modules handle patient randomization, drug supply management, and adverse event reporting, reducing manual effort and improving data quality across multi-site global trials.
Serialization & Supply Chain Integrity
Quorium implements track-and-trace systems that comply with the DSCSA, EU FMD, and other global serialization mandates. Our solutions manage the aggregation hierarchy from item-level to pallet-level and integrate with national drug registries.
We also build cold chain monitoring platforms that track temperature, humidity, and light exposure throughout the distribution network, with real-time alerts and batch-level disposition recommendations.
Our Services for Pharma
Pharma FAQ
We implement electronic signatures with unique user ID/password combinations, system-generated timestamps, and audit trails that capture who did what and when. Our systems enforce record retention policies and produce inspection-ready audit logs.
Yes. Our validation services cover the full GAMP 5 lifecycle: risk assessment, user requirements specification (URS), functional/design specifications (FS/DS), and IQ/OQ/PQ execution. We maintain validation documentation in accordance with regulatory expectations and support regulatory inspection readiness.
Our team has deep experience with CDISC standards including SDTM, ADaM, and Define-XML for regulatory submissions. We build EDC systems that enforce data validation rules at the point of entry, reducing queries and accelerating database lock.
Yes. We build serialization platforms that support GS1 standards, generate unique identifiers, and manage the aggregation hierarchy from item to pallet. Our systems integrate with national repositories and support the DSCSA, EU FMD, and China Drug Traceability requirements.
We follow the ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available. Our systems enforce data governance controls, prevent deletion or overwriting of raw data, and provide complete data lineage from sensor to report.