Clinical study internal review workflows
We build internal review workflows for clinical study documents: document handling, reviewer assignment, progress tracking and approval steps, so your team can see where every document stands. This is a workflow tool for your internal review process. It isn't an EDC, CTMS or validated GxP system unless that's explicitly scoped with your quality team.
What's in scope: Document handling; Reviewer assignment; Progress tracking across documents and reviewers; Approval steps that follow your review process; Role-based access, agreed in the written scope.
Integrations: Connections to document management, single sign-on or other study systems are assessed at discovery against their APIs. We put only confirmed integrations in the scope.
How delivery works: Intro call (Day 1): You describe the programme, the audience and the deadline. We tell you honestly whether we're the right team and roughly what it costs. Discovery sprint (Week 1): Three to five days, $500–1,500, credited if you go ahead within 30 days. You get a written scope, the approval steps, integrations, an estimate and a risk list. Clickable prototype (Week 2): The key screens, designed and clickable, so brand, medical and field teams can react before any code is written. Weekly build sprints (Weeks 3+): Features land on a staging link your team can try. There's a demo every week, and payments are tied to milestones. Go live and hand over (Launch): Production deploy or app store submission, handover documents, and a care plan if you want us to keep it running.
Compliance boundaries: We build the software. Your medical, legal and regulatory reviewers approve every piece of content that goes to doctors, patients or field teams. We don't give medical, legal or regulatory advice. We don't claim GxP, 21 CFR Part 11, HIPAA or other certifications or system validation. If your programme needs a validated system, raise it at discovery so it's scoped with your quality and validation team before we quote. Who can see and approve what (roles, approval steps and the data collected) is agreed in the written scope, not decided by us later. Confidentiality, code ownership and handover terms are written into the project agreement. Ask for an NDA before you share confidential details.
What does the review workflow cover? Document handling, assigning reviewers, tracking progress and recording approval steps for internal reviews of clinical study documents.
Is it a validated or Part 11 compliant system? We don't claim that. If your use needs a validated system or 21 CFR Part 11 controls, tell us at discovery so the requirements are scoped with your quality and validation team before any estimate.
Is this an EDC or CTMS? No. It's a workflow tool for internal document review. It doesn't capture trial data or replace clinical trial management systems.
Can we match our existing review steps? Yes. The approval steps, reviewer roles and who sees what are designed with you and written into the scope, so the tool follows your process.
How is confidentiality handled? Confidentiality and code ownership terms are written into the project agreement, and you can ask for an NDA before you share study details.