Biotraxion
Sign in Request a pilot

Guide

Several sponsors, one laboratory: keeping studies apart without mixing them up

Published October 25, 2026

A sponsor audits your laboratory for their study. On the screen next to it sits a competitor's name. Or a file that was not meant for them. Or, more quietly, a study whose existence they should never have guessed.

This page covers one narrow point: how a bench execution record keeps the studies of several sponsors separate when they run in parallel with the same team of 10 to 50 technicians. It does not replace your confidentiality agreements or your validation. It describes what a system should guarantee, and what it cannot guarantee for you.

The same technician, three studies

In a preclinical CRO the laboratory is shared and the studies are not. A technician works on one sponsor's study in the morning and another's in the afternoon. Same hoods, same instruments, sometimes the same week of handling.

The risk is not a malicious technician. It is ordinary confusion: a file saved in the wrong folder, an export that picks up one line too many, an access granted "just to help out" and never removed. A separation that depends on everyone's attention holds until the busy day.

Separation is what stays true on the days when nobody has time to pay attention.

One study, one wall

Here is what we state: each study is isolated by sponsor. One client's data, files and access never overlap with another's. We say: one study, one wall.

In practice the separation covers what a sponsor could otherwise see of another: the study data, the attached files, and the access rights. It is built into the record. It does not rely on a notice pinned to the laboratory wall.

The limit: that sentence says what the product aims at, not how it gets there. The exact mechanism (where the separation sits, what it protects when an account is misconfigured) is not described publicly. It is a question to put to us as to any vendor.

A wall you cannot locate cannot be validated.

What stays shared, and should

The wall separates studies. It does not separate the people who run them. Your technicians work on several studies, and that is normal.

The release notes show that membership of a CRO study is a notion in the record: an operator can attach their run to a CRO study they belong to, and doing so does not give them read access to the study.

Then comes the question your QA will ask: does a technician assigned to two studies see both, and who decided that? Who can remove the assignment, and where does the trace remain?

Real separation is a right granted study by study, with a trace.

What the wall does not settle

It does not replace contractual confidentiality. What you owe each sponsor is in your contract, not in software.

It does not fix the physical world. A mislabelled sample, a paper notebook left on the bench, a screen visible from the corridor: no record changes that.

It does not replace account management. One account shared by two technicians defeats any separation, because nobody knows who opened what.

It does not decide what GLP expects of you. Identification of each study and archiving of its data fall under your framework (OECD Principles of GLP, sections 8.3 and 10; 21 CFR 58.190 for US GLP).

The wall protects the data. It does not make the laboratory watertight.

The audit trail and the wall

The audit trail is append-only, timestamped and SHA-256 hash-chained, so tampering shows. What that adds to separation: an entry cannot be moved from one study to another without it showing.

The limit: a hash chain reveals alteration. It does not stop data from being entered in the wrong study in the first place. Whether the trail is specific to each study or shared across the laboratory is a question to ask.

QA review, study by study, is what catches the original mistake.

Five questions for any system

  1. What separates two studies: a setting, a rule, or the structure of the record itself?
  2. Can a file uploaded for study A appear, in any form, in study B?
  3. Does a technician assigned to two studies see both, who decided that, and where is the trace?
  4. Does a study's export contain exactly its own data, and nothing from another?
  5. Can you demonstrate this to a sponsor who audits you, without opening the rest of the laboratory?

For the last one, our answer is the Audit Pack: at the end of each study, approved protocol, signatures, deviations and hash-chained audit trail, exported in one click as a sealed deliverable your sponsor and your inspector can verify. Does one study's Audit Pack contain exactly what concerns that study, and nothing from another? Ask any vendor, us included.

See where the wall sits in your lab

We show a sample Audit Pack and go through where your studies cross today: contact@biotraxion.com, or request a pilot from the home page. Product changes are dated in the release notes.

Keep reading

← Back to home