Clinical Documentation That Keeps Pace With Your Research.
Clinical research teams carry a heavy documentation burden — trial protocols, informed consent forms, adverse event logs, regulatory correspondence, and data query management — often across a mix of spreadsheets, email threads, and disconnected files. We build structured digital systems that bring this documentation into one controlled, traceable environment so your team can focus on the science.
Not a full CTMS — a focused workflow system for pharma teams.
We want to be transparent: we are not building a full Clinical Trial Management System to compete with enterprise platforms that have been in this space for decades. What we offer is different — and for many pharma teams, more useful.
We build custom workflow systems that solve specific, painful documentation problems in clinical research — managing protocol versions and amendments, tracking regulatory submissions and responses, organizing site documentation for multi-site trials, and maintaining the Trial Master File in a structured, inspection-ready state.
If you have a specific documentation or workflow problem in your clinical operations, we'd like to understand it and design something that actually solves it.
Trial Master File (TMF) Organisation
TMF documents scattered across shared drives, missing required sections discovered only during inspection, no clear ownership of document completeness.
Protocol Version Control
Multiple protocol versions in circulation, amendment history difficult to reconstruct, sites using outdated versions without the team being aware.
Regulatory Correspondence Tracking
Ethics committee submissions, approval letters, and queries managed through email with no structured record of outstanding items or response timelines.
Adverse Event Documentation
Adverse event reports managed in spreadsheets, notification timelines tracked manually, with no automated prompts for required reporting deadlines.
Custom systems built around your trial structure.
Electronic Trial Master File
A structured eTMF with ICH E6 (R2) aligned folder taxonomy, document completeness tracking, and access controls for sponsor, CRO, and site teams. Always inspection-ready.
Protocol & Amendment Management
Version-controlled protocol repository with amendment tracking. Sites are notified of new versions and must acknowledge receipt before proceeding with updated procedures.
Regulatory Submission Tracker
Track ethics committee and regulatory submissions, approval statuses, outstanding queries, and required renewals — with deadline reminders and a structured correspondence archive.
Adverse Event Workflow
Structured AE and SAE documentation workflow with reporting timeline alerts. Ensures required notifications — to IRBs, regulators, and sponsors — are tracked and completed within defined timeframes.
Informed Consent Tracking
Track consent form versions, confirm that enrolled subjects are consented on the current version, and maintain a complete consent history for each participant — with e-signature support where applicable.
Site Management Documentation
For multi-site trials — track site initiation status, delegation logs, site-specific document versions, and monitoring visit records in a structured system accessible to the central team.
We start with your problem, not a pre-built product.
Clinical research documentation needs vary significantly by organisation, therapy area, and regulatory environment. Rather than selling you a generic tool and asking you to adapt to it, we start by understanding your specific workflow challenges — then design and build a system around them.
If you are exploring options for your clinical documentation, we're happy to have an exploratory conversation about what a custom system could look like for your team — no commitment required.
Start the ConversationTell us about your clinical documentation challenge.
We'll have an honest conversation about whether a custom system is the right solution and what it would take to build it for your organisation.
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