Study Start-Up in 3–5 Days for Pharma & CROs

Where the Weeks Go, and Where They Don’t

Legacy EDC Setup

Week 1: protocol handover, data manager assigned, kick-off call
Week 2: eCRFs built by hand, field by field
Week 3: sponsor review, revisions, final approval and go-live

Climedo Setup

Day 1: upload the protocol (PDF or image) and generate eCRFs, PROs and SAE forms
Days 2–3: review the generated forms, adjust, go live

Set-Up Time by Study Complexity

What drives the timeline: the number of visits and forms, workflows such as SAE reporting and randomization, translations, integrations and the number of review rounds.

Study	Typical examples	Legacy EDC	Climedo
Standard	Observational and non-interventional studies, registries, post-approval studies, ePRO surveys	2–3 weeks	3–5 days
Complex	Many visits, SAE workflows, randomization, several languages or integrations	10+ weeks	2–3 weeks

What Makes It Fast

AI Study Configurator

Your protocol visualized, turned into study specs and generated as a full study, with a human approving each step.

Templates, No Programming

Save modular study elements as templates and reuse them; dependencies and plausibility checks are configured, not coded.

Web-Based, Nothing to Install

Sites, patients and monitors work in the browser; patients join by SMS or email link or QR code.

Ready for Multinational Studies

The translation module configures several languages for eCRF and ePRO forms; messages go out in each participant’s language.

Randomization Built In

Upload a randomization list with up to five strata variables; allocation happens inside the EDC.

eConsent and ePRO From Day One

Electronic consent with an integrated e-signature, and ePRO invitations with automated reminders.

What It Means for Sponsors and CROs

Pharma Sponsors

First patient in sooner: more data inside the same post-approval window.
Pilot, adjust the protocol and relaunch in days.
Sponsor oversight from the start: annotated PDF, settings export and audit trail document every setup decision.

CROs

Faster eCRF build per study, with templates you reuse across sponsors.
Shorter sponsor review rounds: forms are reviewable on day one.
Teams onboarded in hours, without programming skills.

Documented and Inspection-Ready From the Start

Annotated PDF with the full study setup: forms, fields, logic and settings.
Study and survey settings export: forms, fields, workflows, notifications, validations and automated logic.
System audit trail export of every setup change, at any point in time.
Audited against ICH GCP, GAMP 5, FDA 21 CFR Part 11 and EU GMP Annex 11.

Why It Matters for Real-World Studies

Real-world and post-approval studies run under tight timelines. Every week of start-up is a week without data.

Real-world evidence with Climedo

Frequently Asked Questions

How long does study start-up take with Climedo?

From protocol upload to live study typically 3 to 5 days, compared with 2 to 3 weeks with legacy EDC setup.

Do the 3 to 5 days apply to complex studies too?

They apply to standard studies such as observational studies, registries and post-approval studies. Complex studies with many visits, SAE workflows or randomization go live in 2 to 3 weeks, compared with 10 weeks or more with legacy EDC.

Do we need programmers to build the study?

No. Forms are generated from the protocol and refined in a configuration interface; templates, dependencies and validations need no programming.

Can we reuse forms from earlier studies?

Yes. Modular study elements can be saved as templates and reused in new studies.

Is the setup documented for audits?

Yes. The annotated PDF, the study settings export and the system audit trail export document the complete setup and every change to it.

Study Start-Up in 3–5 Days, Not 2–3 Weeks