Clinical CRO, Five Times FDA Inspected: Trial Bioanalysis From Bioequivalence To Biologics

A clinical bioanalysis CRO measures drug, anti-drug antibody and biomarker concentrations in trial samples under GCLP and reports them for your submission. A central lab handles kits, logistics, processing and storage. We run both under one roof, which is why samples never change hands mid-study. The central lab detail lives on its own page.

Phase I through IV. First-in-human dose escalation with rapid PK turnaround between cohorts, Phase II dose finding with PD and biomarker endpoints, pivotal Phase III programs under full GCLP, and Phase IV or post-marketing commitments.

It is the normal case here, not the exception. Your method is developed, validated and parked stable, with stability assessments covering the wait, and batches are analyzed as they arrive. There is no minimum batch size and no upfront sample volume to commit. That is also the honest answer to how 35+ clinical studies run here at once: at any moment some are enrolling while their validated methods stand ready, and instrument time goes to the batches in hand.

Plasma, serum, whole blood and dried blood spots, urine, CSF, tears, synovial and aqueous fluid, PBMC and cell lysates, and tissue homogenates. PK in plasma, urine and CSF runs in the same study without switching laboratories, which is the point of having every platform under one roof.

Good Clinical Laboratory Practice applies GLP-grade laboratory discipline to human trial samples generated under GCP. Method validation, documentation and audit trails follow the same rigor as our regulated preclinical work, applied to your clinical protocol.

Two to three weeks on LC-MS/MS and four to six weeks on ligand binding, to ICH M10 in the context of use. Transfer and cross-validation of an existing method is usually faster than a new build, and both paths are quoted up front.

Yes. The method transfers in, is cross-validated on our instruments against your existing data, and the sample flow redirects with the chain of custody intact. Sponsors usually come to us mid-study after a queue or a quality problem elsewhere, and the transfer is designed so your submission never shows a gap.

Refrigerated at 4°C, frozen at -20°C and -80°C, and liquid nitrogen for cellular material, with 24/7 monitoring and backup generators. Retention runs per your protocol and applicable regulation, with long term storage available after study close.

This year, nearly half our work is large molecule, nearly half small molecule, and about a fifth comes from sponsors running multiple work streams here at once, so yes, and it is routine rather than exceptional. PK on LC-MS/MS, immunogenicity on MSD or ELISA, cytokines on Luminex, genotype on ddPCR and cell counts on flow cytometry, all from one accession, aliquoted in house under one chain of custody. The alternative is splitting your protocol across vendors and reconciling their queues, couriers and data formats yourself.

Yes, and under CLIA with CAP accreditation, which is the tier a patient-level enrollment decision requires. Protocol-restricted substances such as caffeine and cotinine run by LC-MS, genotype and vector-relevant markers by qPCR or ddPCR, pre-existing anti-AAV antibodies by ligand binding, and biomarker cut-offs per your protocol. Results report patient by patient inside the screening window, fed by the same collection kits our central lab builds for the trial, so sites randomize on time.

Since 2003, and they are a named part of our client base. We run the bioanalysis and central lab behind your trial, under subcontract or referral and under your flag where you prefer. There is no site management, monitoring or recruitment business here, so a full-service CRO plugs us into a bid without handing work to a competitor.

A bioequivalence study is the purest test of a bioanalytical lab: the entire approval decision rides on the concentration data, with no efficacy endpoint to lean on. This lab has run BE studies for two decades, and the systems that survive that pressure, method robustness, incurred sample reanalysis and audit-proof documentation, are the same ones behind every clinical study here.

Watson LIMS holds the study data end to end. PK parameters are calculated by noncompartmental analysis in WinNonlin, immunogenicity cut points are established statistically, and tables are delivered eCTD, SEND, SDTM and ADaM ready, so your biostatistics team loads them instead of rebuilding them. Population PK modeling runs through our modeling partner.

Yes. Protocol specific kits are designed, built and shipped to every site. Resupply orders ship within ten business days and supply-only orders within five, with expedited options for enrollment surges. PBMC samples are processed within 8 to 24 hours of collection.