QPS Netherlands

QPS Netherlands is a GLP/GCP/GMP-compliant CRO, specializing in discovery, preclinical, and clinical drug development research.
Located in Groningen, Netherlands, it was established in 1999 and currently has 200+ employees in a 51,000 square foot space.

cCSF study QPS Netherlands

Clinical Trials at QPS Netherlands

Alzheimer’s Disease Clinical Trial Guide

The QPS Clinical Research site in The Netherlands is committed to supporting research to combat Alzheimer’s Disease (AD), and we have created a facility dedicate to the special needs of these study subjects. If you are a sponsor looking for a site for your AD trial, or a looking to participate in an AD clinical trial, this interactive resource provides a closer look at the impressive facility and the special QPS approach to these challenging trials.

Alzheimer’s Disease Clinical Trial Guide – English

Alzheimer’s Disease Clinical Trial Guide – Dutch

Core Competencies

Early Phase Clinical Development:
Phase I & IIa (i.e. FIH, PoC studies, PK studies, and radiolabeled); specialized in CNS, respiratory, women’s health, and special PK studies (CYPs and transporters); supported with scientific expertise and medical oversight, a GMP pharmacy with compounding capabilities and QP release, plus healthy volunteer and patient recruitment.
Clinical Research Services
Project management, regulatory affairs, medical monitoring, CRA, QA, clinical consultancy, trial logistics, legal representation, pharmacovigilance, medical writing/PK/PD/biostatistics, and data management.
Small Molecule and Elemental Bioanalysis:
LC-MS/MS, ICP-MS, LC-ICP-MS, and ELISA-ICP-MS; radionuclide laboratory (D-lab) to support human AME studies and radioimmunoassay (RIA).
Biotherapeutics Bioanalysis:
PK, ADA, biomarkers, cell-based Nab assay, cell-based potency assay using ELISA / MSD / Gyrolab / cell assay platforms, LC-MS methods for peptides, proteins, ADC’s and oligonucleotides. Immunoaffinity LC-MS/MS for exploratory, screening, and regulated bioanalysis of proteins and enzymes.

Facility

58 hospital-based Phase I study beds; refrigerators, synchronized clocks, freezers (-20/-80/-196), emergency call system, centrifuges, IV-pump, spirometry, ECG, defibrillators, telemetry, temperature monitoring.
21,500 square feet of independent bioanalytical facility for small molecules, biotherapeutics, and gene therapy products.
Biosafety level 2 (BSL 2) facility to handle bioanalysis of BSL 2 agents, such as human immunodeficiency virus (HIV), hepatitis virus A, B, C, D, and E (HAV, HBV, HCV, HDV, HEV), influenza virus, coronavirus (SARS CoV, MERS CoV, SARS CoV 2), …
Bioanalytical, biochemical, radionuclide, and cell-culture laboratories.
Sciex mass spectrometry platform with Nexera or Infinity I or Infinity II UPLC front-ends, and Tomtec and Thermo Versette automated liquid handlers: Triple Quad 4000, Triple Quad 6500, Triple Quad 6500+.
Agilent 7700/7800 ICP-mass spectrometers and Agilent 1200 HPLC front-ends, plus DigiPREP digestion equipment.
VersaMax microplate readers, SpectraMax multi-mode plate reader, Meso Scale Discovery S 600 ECL’s, Gyrolab xPlore, BF-FACSCanto II, and Siemens BCS XP hemostasis analyzer.
Gamma and beta counters, radio flow detector, LC-DAD/UV equipment, and oxidizer.
LabVantage LIMS for reporting, data management, analytical run acceptance, sample/materials management, storage management, and equipment validations/ management.

Achievements

12 successful inspections and audits by the Dutch authority (IGJ) and the US FDA in the last 10 years.
150+ client audits with satisfactory outcomes between 2011 and 2019.
Strong collaboration with leading medical centers in The Netherlands (e.g. VUMC, AMC, UMCG, Radboud, MCL, Isala Clinics, and Martini Hospital).

Accreditation

GLP-compliant laboratory as of August 2000.
GMP-compliant laboratory for pharmaceutical analysis as of October 2008.
GMP-compliant pharmacy as of February 2005.
GCP-compliant clinic and laboratory as from July 2005.

Experience in the Clinic

Over 250 Phase I/II/BA/BE studies conducted since inception of the Clinic in 2004.
Disease categories: CNS disorders and (c)CSF sampling, gynecology, infections, respiratory diseases and allergies, cardiovascular diseases, gastroenterology, metabolic diseases and diabetes, anesthesia, pain, inflammatory diseases, and ophthalmic diseases.
Studies have involved >13,000 healthy subjects and >500 patients.
Recruitment database of >22,000 potential study participants.
Administration routes: PO, IV, IM, SC, nasal sprays, and oral inhalation.
Sample types: plasma, whole blood, arterial blood sampling, urine, fecal samples, CSF-fluid (spinal taps as well as repetitive CSF)
Imaging techniques: PET, MRI, fMRI

Experience in Bioanalysis

Extensive validated bioanalysis assay list (1,000+ assays developed and validated in blood, serum, plasma, tissue, saliva, sputum, and formulations — and growing) for which a lower limit of quantitation of 1 pg/mL is no longer an exception.
Over 2,000 bioanalysis studies conducted and more than 1 million samples analyzed.
20+ years experience in development, implementation, and validation of quantitative LC-MS assays for small molecules, peptides, proteins, ADC’s oligonucleotides, and biomarkers, employing multiple bioanalytical platforms.
15+ years experience in development, implementation, and validation of ICP-MS assays for total-, free-, and trace elemental analyses, extended to LC-ICP-MS assays for speciation analysis, degradation/stability studies, or quantitation of parent compounds and metabolites.
Proven expertise with integration of ICP-MS with other analytical platforms: ICP-MS and DAD/UV (diode array) for serial detection, and parallel detection by ICP-MS and LC-MS/MS, or ELISA-ICP-MS for the analysis of metallodrugs, metallic DNA fragments, and metallopeptides.
20+ years experience in development, implementation, validation of ligand-binding, hybridization, and enzymatic assays for the quantification of biotherapeutics and biomarkers in complex biological matrices.