- 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.
Alzheimer’s Disease Clinical Trial Guide
- 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.
- 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.
- 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).
- 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.