If you run or manage a lab supporting early-phase clinical trials, chances are your days look something like this:
- Chasing missing QC logs before a sample run
- Wondering if that lab kit batch already expired
- Trying to trace who edited a result (and why)
- Manually checking critical values buried in long Excel sheets
- Hoping the instrument actually uploaded the right data this time
Sound familiar?
You’re not alone. We spoke to a dozen lab managers, analysts, and QA leads who support BA/BE and early-phase trials. Most said the same thing:
“It’s not the big compliance stuff that gets us—it’s the small everyday things that slow us down or create risk.”
That’s exactly why we built Path-LIMS—a lab information system made for real-life lab work in early-phase clinical trials. Not just another system. A solution that understands the daily grind.
- “I Missed a Critical Value Because It Looked Like Every Other Result.”
When results pour in, it’s hard to spot the ones that actually need attention—especially when they’re hidden in endless rows of values.
Path-LIMS Fix:
Color-coded flags automatically highlight alert-worthy results, so no more missing a value that could trigger a deviation or retest.
- “We sometimes realize only later that a QC step was skipped.”
Most teams are following CAP/ISO standards. But when you’re moving fast, pre-run quality checks get logged late—or worse, forgotten.
Path-LIMS Fix:
Mandatory pre-run QC checks before every test. If QC isn’t done, the test doesn’t run. No exceptions, no backdating.
- “An auditor asked who changed a result—and we couldn’t answer.”
You trust your team, but mistakes or edits happen. What you need is a non-arguable log that tells the full story.
Path-LIMS Fix:
Complete audit trail of every result, every QC action, and every override. What changed, when, and who did it—right there.
- “I can’t always tell if the machine sent the correct data.”
Your analyzers are supposed to upload data, but mismatches still happen. And checking everything manually takes time.
Path-LIMS Fix:
Bi-directional machine sync using HL7/ASTM ensures smooth LIS ↔ instrument data flow—removing re-entry and human error.
- “We’ve had expired lab kits used more than once.”
With paper logs or scattered trackers, it’s easy to lose track of lab kit batches, expiry dates, and availability.
Path-LIMS Fix:
Electronic kit management tracks usage, alerts for expiry, and logs everything by study—automatically.
- “Our review process is all over the place—emails, printouts, folders…”
One reviewer signs off in a spreadsheet. Another writes comments on paper. It’s hard to track what’s reviewed and what’s not.
Path-LIMS Fix:
Multi-level approval workflows with sign-off trails. Review levels are set by role, with full CLIA/CAP compliance.
- “We’re always under pressure to stay audit-ready.”
Inspections come unannounced. And pulling together QC logs, result histories, and approval chains becomes a mad scramble.
Path-LIMS Fix:
Path-LIMS is audit-ready by design—21 CFR Part 11, GLP, EU Annex 11, and CAP/CLIA aligned. No scramble. Just open the system.
- “We can’t afford data privacy slip-ups.”
Early-phase data is sensitive. Especially when it’s linked to volunteers or patients. Most systems don’t do enough to protect it.
Path-LIMS Fix:
Role-based access, field-level masking, and anonymized exports keep subject data protected and compliant with regulations.
It’s Not About Adding More Tools. It’s About Fixing What’s Broken
You’re not asking for another platform. You’re just looking for something that:
- Fits your lab’s real workflow
- Doesn’t require daily hacks to stay compliant
- Saves your team from preventable mistakes
- Gets the job done faster, and cleaner
That’s what Path-LIMS was built for.
Final Word: In a Fast-Moving Study, You Can’t Rely on Memory
You shouldn’t have to remember which kits are near expiry, which results need review, or whether QC was logged.
Your system should remember it for you.
Path-LIMS does.