BioLabOpsBiospecimen study operations, as a service
Every study.Every site.Every specimen.One system of record.
BioLabOps runs the operational side of biospecimen studies: the sites and their files, the subjects and their visits, the specimens from draw to freezer to shipment. Hosted for your organization, with an audit trail behind every step.
One record, end to end
From first site contact to the last shipment
- FeasibilityOpportunities, outreach, qualification visits and the contracts that follow.
- SitesSite files, personnel, expected documents, activation gates that open when the file is complete.
- SubjectsEnrolment, consent records, visit schedules, a data dictionary you define.
- SpecimensCollection events, aliquots, barcodes and labels, chain of custody from the first scan.
- StorageFreezers down to positions, transfers, inventory, with the box in front of you on screen.
- FulfilmentOrders, packing lists, numbered shipments with parcels, receiving at the other end.
The platform
Built around the work a study team actually does
Each module is complete on its own and shares one record, so a site's contract, a subject's consent and an aliquot's position are a click apart.
Trial master file
A file browser for every protocol, study, site and subject, with a folder structure you define once. Expected documents show as placeholders until a file arrives. Drag files in, version them, set expiry, email them to a site, export any level as a zip for an audit.
Site identification and activation
From outreach to approved vendor to activated site, as a process with the steps you configure. Contracts move through stages, vendor approval follows your rules, and activation waits for the documents and visits you say it should.
Storage, down to the position
Freezers, racks, shelves, boxes and positions, modelled as they stand in the room. Transfer by picking positions on screen, scan to fill, take inventory, keep the sellable pool apart from study samples.
Kits, shipments and receiving
Kit definitions, lots and build days. Numbered shipments with one or several parcels, courier and tracking per parcel, expected arrival on the calendar. Receiving matches what arrived to what was sent.
Search and reports
Search across subjects, specimens and aliquots, summarize as a pivot, save it, export exactly what is on screen. Reports with date ranges, dimensions and totals; the shipping screen is itself a report.
Calendar and notifications
Planned shipments, site visits, kit build days and any activity kind you add to the vocabulary, on one calendar. Email for the record, a text message for the urgent ones.
Dashboard
The day, before you go looking for it
- A morning briefing. What is waiting on you: documents to review, shipments due, visits this week, steps blocking a site.
- The studies at a glance. Protocols, studies, subjects and enrolment, with the sites still setting up and what each one is missing.
- Samples and lab. Boxes in use, positions occupied, aliquots by custody, kits from planned to used.
- Every number is a link to the records behind it.
Trial master file
The file, filed the way an inspector expects
- One tree for the whole file. Protocols hold their studies, studies hold their sites, each with the same folder structure.
- Expected documents as placeholders. What is still missing is visible before anyone asks for it.
- Drop files in, version them, set expiry. Several at once, straight from the desktop.
- Export any level as a zip with a manifest, for an audit or a sponsor.
Specimens and storage
Know where every aliquot is, and how it got there
- The box on screen. Pick positions visually when you transfer; scan to fill when you receive.
- Chain of custody from the first scan. Every placement, transfer, pick and shipment is a movement with a who, a when and a reason.
- Labels that match your scheme. Layouts and sequences you define, printed to ZPL or PDF.
- Inventory and consent together. The sellable pool is the consented inventory, nothing else.
Calendar and notifications
Everything dated, on one calendar
- Shipments, visits, kit builds, audits, expiring documents and maintenance due, each in its own colour.
- Plan by clicking a day. Activity kinds are a vocabulary you extend.
- Email for the record, a text for the urgent. Notifications go out on your organization's own accounts.
Configure, not customize
Your procedures, as settings
Numbering schemes, mandatory steps, review requirements, option lists, folder structures, status workflows and permissions are all settings your organization owns. The platform stays one product; your rules make it yours.
- 30 working rules, each a switch with its consequence written next to it.
- 24 vocabularies for specimen types, couriers, roles, kit components and more.
- 29 status workflows with the stages and transitions you decide.
- Processes with steps for site qualification, activation and study set-up.
Compliance
Designed to be inspected
Operational software in a regulated setting has to show its work. BioLabOps keeps the evidence as a matter of course, so an audit is a report to run rather than a week to prepare.
Who it is for
Teams that move specimens and the paper that goes with them
Biospecimen providers and biobanks
Run collection studies across sites, keep a consented inventory, and fulfil orders with packing lists and manifests that carry box and position.
IVD manufacturers
Collect the specimens your clinical evidence needs, by protocol and by site, with the chain of custody a submission has to show.
CROs and SMOs
Site files, activation and visit tracking for the sponsor, with the specimen side in the same system instead of a spreadsheet.
CDMOs
Receive, store and release client material against orders, with every movement recorded and every release signed.
Diagnostics developers
Stand up collection protocols quickly, qualify sites, and know where every sample is while the assay is being built.
About BioLabOps
Sixty years in life sciences and software, in one product
BioLabOps comes from two careers that rarely meet: one spent building software and companies, the other spent running diagnostics, laboratory and clinical research operations. We built the platform we kept wishing someone would.
It takes the regulatory requirements of this industry as given and builds the operational workflows on top of them, with the help of agentic software development, so a study team gets a system that already works the way their SOPs say it should.
Zohrab Bostanian
Co-founder and CEO
Thirty years from corporate leadership in in-vitro diagnostics to entrepreneurship in clinical evidence, at a reference laboratory and a contract research organization. He knows what an inspector asks for and what a site can actually do, and that is what the product enforces.
Dikran Hovagimian
Co-founder and CTO
Thirty years of software development and entrepreneurship, from hands-on coding to building agentic workflows that turn a complex process into a system people can run. He builds BioLabOps and keeps it one product for every customer.
Request a demo
See it on your own kind of study
Tell us a little about your work and we will set up a walkthrough on a tenant that looks like yours. A real study, real sites and real boxes, not a slide deck.