Case Study · Florence Healthcare

Clinical DocumentIntelligence.

Florence is the trial operations platform that connects research sites to the sponsors running their studies. Our engineers embedded inside their team to help push AI initiatives across the full product suite including eBinders site file, SiteLink, eTMF, eConsent, and Site Feasibility. Every document on it carries a regulatory state and an audit trail that has to survive an inspection years later.

Less manual document review: 75%Less manual document review
Research sites connected: 65,000+Research sites connected
Countries covered: 90+Countries covered

Engagement Overview

A clinical trial is how a drug is proven, and almost all of that proving is documentation. Every protocol, consent form, training record, financial disclosure and investigator qualification has to be filed, versioned, signed and kept retrievable for years, at every hospital running the study and again at the sponsor coordinating them. Florence Healthcare is the platform that estate runs on. It connects more than 65,000 research sites to over 600 sponsors and contract research organizations across 90+ countries, and it has been named the industry's top clinical trial technology six years running.

The platform consists out of five products. eBinders is the research site's own regulatory file. eTMF is the sponsor's master archive of the same study. SiteLink is the connection between them, carrying documents and remote monitoring in both directions. eConsent handles the moment a patient agrees to take part. Site Feasibility decides which sites should run the study in the first place. Nortik engineers across all five.

Nothing here is ordinary web software. Florence operates under 21 CFR Part 11, HIPAA, GDPR, EU Annex 11 and ICH E6(R3), with configurable retention out to 25 years. A field change is an audit-trail row. A missed redaction is a patient data breach. A document that cannot be produced on request is an inspection finding against the trial itself.

75%
Less manual document review: 65,000+
Research sites connected: 90+
Countries covered

Engagement: Staff Augmentation / Embedded engineering team
Team: 5 AI Software Engineers
Focus: eBinders, SiteLink, eTMF, eConsent and Site Feasibility
Working model: Inside Florence's product teams

Stack

Frontend

TypeScript
Angular
RxJS

Backend & APIs

Node.js
REST APIs

Data & storage

PostgreSQL
Amazon S3

Infrastructure & DevOps

AWS
Docker
CI/CD

Compliance & security

Role-Based Access Control
Audit Logging

A researcher in a white coat loading a sample into a bench analyzer in a clinical laboratory

The Challenge

A single study binder is not a folder of files. It is a few hundred documents, each in one of a dozen states at once: filed, expired, almost expired, awaiting a signature, awaiting a monitor's review, superseded by a version nobody has countersigned yet. Multiply that by the sites running the study, then by the studies a sponsor has open, and the estate stops being something a coordinator can hold in their head. Florence's own Global View counts it out loud: 203 documents, 77 placeholders, 59 pending signatures, 271 with no monitoring status.

What makes it hard is not the volume. It is that the volume is regulated. Under 21 CFR Part 11 every change is an audit-trail row that has to be reconstructible years later. Under HIPAA and GDPR a redaction that misses one line of patient data is a breach, not a bug. Retention runs out to twenty-five years, which means software written today has to produce a legible, provable record long after the study closed and the team moved on.

And it has to be usable. The people on the other side of the screen are coordinators and monitors with patients waiting, not administrators. Ship something correct but slow and sites go back to paper, where roughly 200,000 of them still are. Ship something fast but wrong and a trial picks up a finding. Both failure modes are expensive, and only one of them is visible before an inspector arrives.

The Solution

Florence is one platform covering both sides of a clinical trial and the full life of a study, from the first binder a site builds to the record an inspector reads years after it closed. Eight surfaces carry most of that weight. Here is what each one does, and why it is harder than it looks.

The binder a research site actually lives in

eBinders is the electronic Investigator Site File, the regulatory record a hospital keeps for a study it is running. Florence calls it the industry's number one eISF and roughly 90 percent of their network is on it. The screen that matters is the Global View: every document in the study sorted by the state it is in, so a coordinator opens one page and knows what is expired, what is due, what is waiting on a signature and what no monitor has looked at yet. Underneath it sits the binder tree, the regulatory structure a trial is legally required to keep. Nortik engineers across this surface.

eBinders
eISF
Document State

Study startup, which is mostly structure

Before a site files a single document, someone has to build the shape of the binder: which folders exist, what belongs in each, what is required versus optional, and which placeholders are waiting on a document that does not exist yet. Florence turns that into reusable structure templates, so a sponsor's standard eISF or a therapeutic area's own layout can be applied to a new study instead of rebuilt. It is the least glamorous part of the platform and the one that decides whether startup takes weeks or months. Florence puts the reduction at up to 40 percent on start-up time.

Study Startup
Structure Templates
Placeholders

One document, and everything that can happen to it

A CV gets renewed. A protocol gets amended. A licence expires. Each of those is a new version that has to supersede the old one without erasing it, carry a reason, reset or clear an expiration date, and leave the previous version reachable forever. The same document can also be locked, tagged, assigned as a task, or flagged as containing patient data so redaction rules apply. This is where the regulatory weight actually sits: not in storing a file, but in proving what it was, who changed it, when, and why.

Version Control
Expiry & Renewals
PHI Handling

A signature, end to end

Most regulatory documents are worth nothing until the right person signs them, and that person is usually a principal investigator who is with patients. Florence runs the whole chain: a signature request raised against a specific document, an email that reaches the investigator wherever they are, a signing session that verifies who they are, and a Part 11 compliant record on the other side. The queues along the top of the application are the honest view of a study's health, because a document waiting on a signature is a study waiting on a signature.

Part 11 eSignatures
Signature Queues
Audit Trail

Florence SiteLink monitor review: a financial disclosure form open with view, annotate, redact and sign tools beside a monitoring queue

SiteLink, or how a sponsor sees 149 sites at once

A sponsor does not run a trial in one place. It runs the same study at dozens or hundreds of hospitals and has to know the state of all of them. SiteLink is the connection: always-on access to site documents, remote monitoring with pre-visit review, direct access to redacted participant binders, automated quality control and proactive flagging of what is missing or incomplete. It is what let Pfizer activate 149 sites in 30 days across six countries without a monitor boarding a plane, and it is the reason documents stop being emailed around.

SiteLink
Remote Monitoring
Document Exchange

A Florence eTMF Global View: document counts by state above the numbered TMF reference model folder structure

eTMF, the file the regulator eventually reads

Everything a site holds has a counterpart on the sponsor's side: the Trial Master File, the complete archive of the study as a whole. It follows the industry's reference model, the numbered structure from trial management through regulatory, safety reporting, data management and statistics, and it is what an inspection is run against. Florence wires the TMF directly to the site binders underneath it, so documents flow into place instead of being collected at the end. Their reported effect is an eTMF quality pass rate moving from 65 percent to 98.7 percent.

eTMF
TMF Reference Model
Inspection Readiness

A Florence eConsent participant roster: eighty participants with screening ID, consent status, enrolment ID and study arm, and LAR badges where a representative signed

eConsent, where the patient says yes

Before anyone joins a trial they have to be told what it involves and agree in writing. It is an ethics requirement, not paperwork, and consent failures are among the most serious findings an inspection can produce. eConsent runs it digitally: consent on any device, remotely or in the clinic, with identity verified for remote signers, and legally authorised representatives handled where a participant cannot sign for themselves. The hard part is what comes after. When a protocol is amended, everyone already enrolled has to be re-consented on the new version, and the study team has to know at a glance which of eighty participants has and which has not.

eConsent
Re-consent Tracking
Identity Verification

A Florence study site view: a recruiting hospital in Taiwan with its document counts and a table of documents by type and version

One site, anywhere in the world

All of it resolves to a single screen. A sponsor opens one hospital in Taiwan, recruiting, eISF active, and sees its whole document estate: thirty-three documents, two waiting in the inbox, eighteen filed, thirteen withdrawn. Each one is typed against the reference model, an Investigator Brochure or a Financial Disclosure Form or a protocol amendment at version seven, and each carries the version history behind it. Sixty-five thousand sites across ninety countries is an abstraction until you open one of them, and this is what one of them looks like.

Site Oversight
Document Tracking
Global Studies

A researcher in a white coat loading sample tubes into a laboratory instrument

Business Impact

The best regulatory software is invisible. A coordinator opens the study, sees the four documents that expire this month, renews them, and goes back to the patients waiting down the hall. A monitor reviews a site's file the night before a visit instead of flying out to find it incomplete. An investigator signs a form from a phone between clinics. Nothing in that sequence is memorable, and that is the whole job.

Repeated across a network this size, invisible adds up. Florence reports 70 percent faster last-mile study startup against the average for a top ten pharmaceutical sponsor, eTMF quality pass rates moving from 65 percent to 98.7 percent, and 141 million dollars a year of operational cost taken out across their site network. Those are platform-wide figures and Florence's own, not one team's scorecard. What they describe is the compound effect of a lot of unglamorous engineering landing correctly.

The part that matters most does not have a number attached. Roughly 200,000 research sites worldwide still run this on paper. Every one that moves across is a study that starts sooner, a monitor who does not need a flight, and a record that can be produced on demand a decade later. Clinical trials are how medicine gets proven, and the software underneath them decides how long that proving takes.