Under Pressure, On Time:Submission-Ready Data in Four Days

In clinical studies, something will eventually go wrong. The real question is what happens next.

In a recent scenario, a client lost access to dozens of subject visit results through a standard electronic integration. A LIMS (laboratory information management system) issue at a study lab meant the only available data were PDF reports from Spanish-speaking sites. These weren’t marginal data points, they were full safety panels tied to end of study visits.

Database lock was quickly approaching, and there was no flexibility on the date. This is where experienced lab data management services make all the difference.

Our Approach

LabConnect had four business days to move from static PDF reports to clean, usable, transfer ready data in our LIMS. There wasn’t a template for this. We had to make decisions quickly and execute carefully.

First, we focused on getting the data into a form we could trust. While formal translations were underway, we used internal tools to support rapid Spanish to English translation so work could start immediately. We designed a data entry template specific to the structure of these reports, which differed significantly from our standard lab exports. The team manually entered, reconciled, and quality checked hundreds of results in parallel, applying the same validation standards we expect from automated integrations, despite the compressed timeline.

At the same time, we worked closely with Scientific Services to address the scientific and operational nuances that came with this shift. Units didn’t always align. Some assays were reported differently than expected. Certain values didn’t fit existing harmonization rules. In several cases, key collection details like fasting status were missing and had to be resolved deliberately rather than assumed.

We also made sure we weren’t solving only the immediate problem. A new processing interface was built so the entered data could move cleanly into the LIMS. Every exception and anomaly was logged. Special handling was documented so the sponsor would receive the most complete dataset possible, even when only partial panels were available. Production Accession numbers were secured early to avoid downstream delays. The goal wasn’t just to meet the lock date. It was to get there without creating additional work or risk for the sponsor.

The Result

All data was successfully loaded into LabConnect’s LIMS and delivered through the standard transfer process. From the sponsor’s perspective, there was nothing new to manage or accommodate.

Because we documented carefully and anticipated the possibility that more data could be uncovered before lock, when additional PDFs surfaced during final reconciliation, we were able to repeat the process quickly so database lock could proceed as planned.

Why This Work Matters

Lab data sits at the center of study decisions, and when upstream systems fail, timelines don’t stop. What matters in those moments isn’t just technical capability, but judgment. It’s having confident teams that know how to move fast without lowering the bar.

This is the difference experience makes. When the expected path disappears, we build a reliable alternative, protect data quality, and keep studies moving forward. This isn’t just about reacting quickly. It’s about doing the right work the right way, even under pressure.

This isn’t an exception. This is how we expect the work to be done. If that’s the kind of data management partnership you’re looking for, let’s connect.