Clinical documents, laboratory data, quality records and regulatory submissions - managed with the data integrity and inspection readiness the life sciences sector depends on.
Pharma, biotech, CROs and medical device companies run on documents - protocols, case report forms, lab notebooks, batch records, validation files and submissions. Regulators inspect these records, and inspectors follow the data.
We build records and content programmes that keep R&D information complete, accurate and traceable - from discovery through clinical development to manufacturing - so your next inspection is an opportunity, not an event.
Four solution areas cover the information demands of the life sciences sector.
Protocols, case report forms and study files controlled, versioned and indexed.
Paper lab records and instrument output converted into indexed, searchable data.
QMS documents, deviations, CAPAs and change controls organized for review.
Submission-ready document sets assembled, tracked and controlled.
Controlled documents with approval workflows and full revision history.
Complete, immutable logs of who saw, changed and approved what - and when.
Records tagged by study, site, subject, batch and document type.
Laboratory data linked to the systems your scientists already use.
Access-controlled storage for paper and digital R&D records.
Processes aligned to data integrity and GxP expectations.
Long-term retention of study and batch records for your retention windows.
Documentation and evidence ready for system validation reviews.
Four recurring pain points in R&D information management, each with a working solution.
Versioned documents, immutable audit trails and ALCOA-aligned workflows make your data defensible before an inspector ever asks.
Unified metadata indexing and LIMS integration give scientists one place to find every study and batch record.
High-accuracy digitization turns legacy archives into searchable records indexed by batch, product and date.
Role-based access, encryption and full audit trails keep proprietary data and documentation protected.
Submission-ready documents assembled and controlled without last-minute searches.
Evidence packs assembled in hours with every record traceable to its source.
Proprietary data guarded behind strict access controls and audit trails.
Scientists spend less time hunting records and more time on discovery.
Complete, accurate and traceable records you can defend in any review.
CROs, sites and sponsors work from one controlled source of truth.
We map your document flows, systems and inspection history.
We assess data integrity gaps and information risk.
We design the target records and workflow architecture.
We build digitization, integration and control workflows.
We validate accuracy, integrity and audit readiness.
We roll out with training and documented procedures.
We manage SLAs, monitoring and continuous improvement.
Established platforms and methods, applied with scientific discipline.
Controlled document platforms with versioning and approval workflows.
Laboratory and clinical systems wired into a single records layer.
OCR and AI extraction for batch records, lab notebooks and study files.
Dashboards that surface study, quality and lab operational insights.
We understand studies, submissions, GxP and inspection dynamics.
ALCOA-aligned records built into every workflow we deliver.
Records, digitization and systems from one accountable team.
Evidence-ready documentation for system validation reviews.
Tell us your study pipeline, record volumes and system landscape - we'll show where your data integrity holds up and where it doesn't.
Request a consultation and we'll map the right records and data programme for your pipeline.
Controlled documents with versioning, approvals and audit trails.
View ServiceDashboards and insights across your study, quality and lab operations.
View ServiceYour lab and document platforms run, patched and monitored for you.
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