Pharma operations span clinical trials, quality systems, and QC labs. Three disciplines, three teams, three sets of standards. Each runs to its own SOPs and reports to its own auditors, and combining them inside a single platform usually means asking one team to live in software built for another. LabRelations takes a different approach: CTMS and EDC built for clinical operations, QMS built for QA, LIMS built for QC and stability. Each system stands on its own and is designed around the work that team actually does.
Underneath, they share a common data model and APIs, so when a QC deviation needs the batch context, or a clinical study needs to flow into stability planning, the connection is already there. GxP, 21 CFR Part 11, EU GMP Annex 11, and ALCOA+ are built into every action across all three.
Three separate platforms, each built for the team that actually uses it. Wired together when that helps, kept apart when it doesn't.
CTMS for studies, sites, subjects, and milestones. EDC for eCRFs and clean data capture. eTMF that builds itself as the trial runs. Sponsors, CROs, and sites work off the same record instead of trading spreadsheets and email.
QMS for documents, SOPs, deviations, change control, training, supplier qualification, and risk. CAPAs run from open to close in one place. When an SOP changes, the right people get re-trained automatically.
LIMS for sample registration, testing, results, instruments, inventory, and CoAs. Stability studies are first-class. Methods, approvals, and audit trails all live in the same system, so QC chemists aren't switching tools to finish a single test.
Yes. The three systems share a common data model and APIs underneath. If clinical wants study data feeding stability planning, or QA wants visibility into QC deviations, that's a configuration, not an integration project.
Every action is logged with a user and timestamp. Electronic signatures are part of the workflow, not a separate plugin. Audit trails are exportable for inspectors and filterable by user, time, and object.
Configuration in the UI doesn't break validation. The validation envelope covers the configuration model, so changing a workflow, field, or approval path is a controlled change, not a code release.
Yes. APIs, standard interfaces, and direct instrument integrations. ERP, BI, EDC, document management, lab instruments. You don't have to rip out what already works.
A mix of people who've who'ved worked in the industry (usually CRAs, QA managers etc) backed by technical people for configuration needs inside the platform itself. They know the difference between an OOS, an OOT, and a deviation without having to ask.
