Upload your protocol and the AI shows how your study maps to Climedo, turns it into study specifications and generates the study: forms, visits, randomization, ePRO, edit checks, queries and the SAE workflow. Protocol changes take the same path as reviewed amendments, and your team approves every step before anything is created.
Five steps from the first protocol upload to user acceptance testing, each with a human checkpoint.
The AI draws the study as visits, forms and data points, with notes on what Climedo supports and the questions the document leaves open.
The visualization becomes a structured study specification. Already have specs workbooks? Start from those instead.
Review the create plan, approve it, and Climedo builds forms, visits, randomization, ePRO, dependencies, edit checks and SAE forms.
Describe a change in plain language and review every new, changed and removed item before it is written back as an amendment.
The AI compares your requirement documents with the configured study before user acceptance testing starts.
Five screens of the workspace, from the protocol upload to the check against your requirements.
Drop the protocol as PDF, Word or image. The AI draws visits, forms and fields with their dependencies, notes why it created each one and flags what needs a workaround or is still open.
One click turns the visualization into a structured study specification, or the AI reads your specs workbooks. Where something is ambiguous, it asks before it continues.
The create plan lists what Climedo will build: forms, site visits, randomization, ePRO with reminders, tab dependencies and validations that raise queries. Approve and execute.
Describe a change to the running study in chat and review the write-back plan, with every item marked new, changed or removed and a warning when recorded answers are affected.
Attach your requirement documents and the AI checks the configured study against them, listing missing items, mismatches and setup issues with their place in the document.
eCRF forms with every field type, including tables, matrices and repeating groups, with display and export labels.
Site visits in protocol order, with the forms placed on each visit in the order staff fill them, and randomization set up from the protocol.
Patient steps with trigger, channel, invitations, reminders and expiry.
Study validations that check entries across the study and raise queries automatically.
Visibility rules between fields and tab dependencies that unlock forms when they are needed.
(S)AE forms placed on the safety workflow, separate from the visit schedule.
A data manager reads the protocol, writes the specs and builds every form, visit and edit check by hand. The sponsor reviews, revisions follow, then a second review round before go-live.
Day 1: upload the protocol, review the visualization and the study specs. Days 2–3: approve the create plan, adjust and go live. Reviews start on day one, because sponsors see the study take shape.
AI-assisted, not AI-alone: the AI asks when the protocol is ambiguous, you confirm how the specs are organized, nothing is created before you approve the create plan, and amendments show every change before they are written back. The AI runs in private model instances in Frankfurt, inside Climedo’s EU cloud, and your protocols are never used to train public AI models.
The AI Study Configurator sets the study up, Photo Capture brings source data in and AI Medical Coding structures it.
Autonomous Data Capture 
· AI Medical Coding · Blog: study setup in 3–5 days
A study protocol as PDF, Word or image, or specs workbooks in Excel or CSV, such as eCRF specifications, ePRO settings and validation lists. For changes, you start from the study that already runs in Climedo.
The study with its forms and fields, site visits, randomization and ePRO steps with invitations and reminders, field and tab dependencies, study validations that raise queries, and the (S)AE forms on the safety workflow.
Yes, at every step. You refine the visualization in plain language, answer the AI’s questions, review the create plan tab by tab and approve it before anything is created in Climedo.
Import the running study, describe the change and review the write-back plan, with every form, field, visit and validation marked as new, changed or removed. It is applied as a study amendment in Climedo.
No. It takes over reading, specifying and building field by field. Your data managers review, adjust and approve every step, and stay in control of the study design.
All of it: protocol visualization, study specs, full study generation, amendments and the AI-supported UAT check. Building study forms from the protocol has been live with customers the longest.