QPS Global Capabilities Presentation
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QPS is a GLP/GCP-compliant contract research organization (CRO) supporting discovery, preclinical and clinical drug development. We provide quality services to pharmaceutical and biotechnology clients worldwide.
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- 1. Presentation for: Sponsor MMM DD, 2011
- 2. How do we Introduce Ourselves to You?
- QPS Linearly Integrated Core Competencies
-
- Early Stage Clinical Development
-
- Late Stage Clinical Development
- 3.
- What are our core values as a company? We believe in
- Direct Peer-to-Peer Interactions
- Timeliness / Fast Turnaround
- Cost Effective Sourcing Solutions
Our Principles
- 4. History 1994 Bio-Kinetic Clinical Applications (BKCA)
founded 1995 QPS (Delaware) founded 1999 Xendo Drug Development
founded 2004 QPS Taiwan founded >>> 2008 QPS acquired BKCA
to establish QPS Bio-Kinetic >>> 2010 QPS acquired Xendo
Drug Development to establish QPS Netherlands >>> 2010 QPS
acquired CTPS to establish QPS-CTPS Taiwan >>> 2011 QPS
acquired Qualitix to establish QPS-Qualitix Taiwan >>>
>>> >>> >>> 1984 Center of Toxicology
and Preclinical Sciences (CTPS)/DCB founded >>> 1990 2000
2011 1997 Genovate/Qualitix founded >>> 2011 QPS acquired
Bioserve to establish QPS-Bioserve India >>> 2005 Bioserve
founded >>>
- 5. Brief Corporate Overview
- QPS offers breadth and depth, plus seamless integrated service
from drug discovery to regulatory
- submission within the context of our six core competencies
- QPS is a global service provider to the pharmaceutical,
biotechnology and generic industries
-
- DMPK (Discovery -> Development)
-
- Bioanalysis (Small Molecules -> Biologics)
-
- Translational Medicine (Genetic -> Protein Biomarkers)
-
- Early Stage Clinical Development (Phase 0 -> Phase IIa)
-
- Late Stage Clinical Development (Phase IIb -> Phase IV)
- Strategically located sites (750+ employees) in North America,
Europe & Asia:
-
- QPS Delaware (Newark, DE USA)
-
- QPS-Biokinetic (Springfield, MO USA)
-
- QPS Netherlands (Groningen, The Netherlands)
-
- QPS Taiwan; QPS-CTPS Taiwan; QPS-Qualitix Taiwan (Taipei,
Taiwan)
-
- QPS-Bioserve India (Hyderabad, India)
- 6. Global Presence Servicing customers all over the world
- 7. QPS Linearly Integrated Core Competencies
- Have it all done in one place. Save your time. Save your
money.
- Since it is a long way (navigating your way.) to the
bedside
- Discovery/Candidate-Selection Stage
-
- ADME and Tolerability Studies to support Drug Discovery
- Preclinical/Non-clinical Development Stage
-
- Animal Toxicology studies to support regulatory filing
-
- Development DMPK studies to support regulatory filing
-
- Regulated Bioanalysis to support animal toxicology studies
-
- Immunogenicity for PD and safety assessment
-
- Biomarkers for animal pharmacology studies
- Clinical Development Stage
-
- Phase 1 Healthy Volunteer studies
-
- Phase 2 to 4 Patient studies
-
- Development DMPK studies to support NDA filing
-
- Regulated Bioanalysis to support clinical studies
-
- Immunogenicity for efficacy and safety monitoring
-
- PGx for patient stratification and efficacy monitoring
-
- Biomarkers for efficacy and safety monitoring
- 8. Slide Deck Navigator
- Global Toxicology Services
- Global Bioanalytical Services
- Global Translational Medicine Services
- Global Early Stage Clinical Development Services
- Global Late Stage Clinical Development Services
- 9.
- helping you navigate your way through
- the biotransformation of your drug
- 10.
- DMPK services include the necessary studies for regulatory
filing at the appropriate time
- and mechanistic studies when required
-
- Single and Multiple Dose, Dose Proportionality, Absolute
Bioavailability, PK/TK Modeling
-
- Mass Balance/Excretion/Radiolabel Studies
-
- Formulation Optimization, Intestinal Permeability, other
Mechanistic studies
- Protein Binding; RBC/Plasma Distribution Partitioning
-
- Quantitative Whole-Body Autoradiography (QWBA)
-
- Micro-autoradiography (MARG)
-
- Metabolic Stability, Species Comparison
-
- CYP450 Inhibition/Induction
-
- Metabolic Reaction Pathway Profiling
-
- Metabolite Profiling & Identification In Vitro,
Preclinical, and Clinical
Global DMPK Services
- 11. Global DMPK Services
- QPS staff's experience is our biggest asset
- Team of senior DMPK scientists that all have on average 15+
years of pharmaceutical and biotech drug discovery and development
experience.
-
- All were DMPK representatives on discovery and/or development
teams.
-
- Worked on > 50 INDs and > 10 NDAs.
-
- Worked in different therapeutic areas (Antiviral, CV, Oncology,
Pulmonary_
-
- The same group of scientists also has on average additional 9+
years of CRO experience.
- Scientific Integrity and Quality
-
- Each DMPK management team member has in-depth skill sets in
different fields:
-
-
- Pharmacokinetics & Protein Binding
-
-
- QWBA & Micro-autoradiography
-
-
- Metabolite Identification
- Program Development Consulting
- Address routine and mechanistic ADME issues
- ADME Summary for Regulatory Submission
- 12. Global DMPK Services
- QPS performs cost effective discovery ADME screens
-
- Validated process with FDA approved specific probe substrates
and chemical inhibitors
-
- Equilibrium dialysis using conventional device or RED or
HT96
- Rodent PK linearly integrated
-
- In-life Discrete or N-in-1 dosing
-
- Bioanalysis method development & sample analysis
-
- Average turnaround time < 7.5 days from compound receipt to
reporting of data
- 13. Global DMPK Services
- Candidate Selection Studies
- QPS experienced staff knows how to select your best IND
candidates
-
- Formulation, dose proportionality
-
- Other mechanistic studies for absorption and disposition (or
clearance)
-
- Metabolite profiling and/or identification
-
- Route of elimination BDC studies
- 14. Global DMPK Services
- QPS has proven innovative study design and executional
excellence for radiolabeled studies
- Combination Mass Balance /Excretion QWBA study to address MB,
tissue distribution, and human radiation dosimetry questions
-
- Better technical oversight
-
- Eliminate the possibility of radiolabel degrading over an
extended period of time between the two studies and the requirement
of re-purification
-
- Increase efficiency using a single study protocol = Study
Cost
- Metabolite Profiling and Identification in the same study
-
- Both ion trap and quadrupoles tandem mass spectrometers for
different MSn experiments
Average Recovery 93.8%
- 15.
- QPS Delaware DMPK Facility
- DMPK function with all necessary equipment and self-contained
for speed
- Vivarium focus on mouse and rat with nine (9) rodent rooms
-
- Triple cannulated animals for special models & in situ
CSF
-
- Intracranial infusions for up to 7 days
- Eight (8) bioanalytical labs for dose formulation, sample
preparation, and analysis
-
- Mass Balance Cages (Plastic and Glass)
-
- Micro-Filter Cages for Mice, Nude Mice and Rats
- In Vitro cell culture Lab
-
- S9, microsomes, and hepatocytes
-
- Tumor cell-lines for xenografts
Global DMPK Services
- 16.
- QPS Delaware DMPK Facility
- DMPK function with all necessary equipment and self-contained
for speed
- Two (2) Autoradiography Labs for Macro- and
Micro-autoradiography
-
- Leica CM 3600 Cryomacrotome (whole-body)
-
- Leica Vibratome 9800 (whole-body)
-
- Leica CM 3050 S Cryomicrotome (individual organ/tissue)
-
- Molecular Dynamics Typhoon 9410 Imager
-
- Six (6) Imaging Research MCID Elite Systems
-
- Liquid Scintillation / Gamma Counters
-
- Microplate Scintillation Counter
-
- Radioactivity / LC Detectors
Global DMPK Services
- 17.
- QPS Delaware DMPK Facility
- DMPK function with all necessary equipment and self-contained
for speed
-
- Three (3) bioanalytical labs for sample preparation and
analysis
-
- Six (6) Mass Spec (5 Sciex API 4000s, Finnigan LTQ
ProteomeX)
-
-
- Waters UPLCs, Shimadzu VP-series LCs, Agilent 1100 LCs; LEAP
HTC/PAL injectors
-
- Detectors UV/Vis, Fluorescence, Electrochemical
-
- Tomtec Quadra 96 for 96-well sample preparation
-
- Two (2) Packard Model 307 Sample Oxidizers
-
- Two (2) PE Tri-Carb 2800TR/2900TR Scintillation Counters
-
- PE TopCount NXT Microplate Scintillation Counter
-
- Packard Cobra II Gamma Counter
-
- Four (4) Radioactivity Detectors
-
- ARC XFlow System; Off-line Fraction Collectors
Global DMPK Services
- 18.
- QPS Delaware DMPK Facility
- DMPK function with all necessary accreditation, certifications,
permits, and licenses
- DEA Permit for Scheduled Control Substances (I-V)
- Federal Fish & Wildlife Permit
- NRC License for Radiochemicals
-
- 3 H, 14 C, 32 P, 33 P, 35 S, 45 Ca, 51 Cr, 90 Y, 99m Tc, 111
In, 125 I, 188 Re
Global DMPK Services
- 19. Slide Deck Navigator
- Global Toxicology Services
- Global Bioanalytical Services
- Global Translational Medicine Services
- Global Early Stage Clinical Development Services
- Global Late Stage Clinical Development Services
- 20.
- helping you navigate your way through the safety of your
drug
- 21.
- QPS-CTPS Taiwan is one of the most experienced toxicology
centers in Asia
-
- Over 1000 GLP Studies since 1997
-
- 17 dossiers compiled for US FDA IND submission
-
- 18 dossiers compiled for Taiwan IND submission
- Accreditations & Compliance:
-
- AAALAC Accreditation since 2000
-
- Taiwan Accreditation Foundation (TAF) ISO 17025
-
- Taiwan Department of Health (DOH) GLP
Global Toxicology Services
- 22.
- QPS-CTPS is able to provide you the complete battery of
toxicological tests that is needed for
- the filing of your IND submission
- General & Reproductive Toxicology
- General (non-GLP) Toxicity Testing
Global Toxicology Services
- 23.
- General & Reproductive Toxicology
- QPS-CTPS is able to provide you with a comprehensive package of
in vivo toxicology studies
- Single Dose Toxicity Studies
- Repeated Dose Toxicity Studies
-
- Routes of administration: oral, intravenous (injection and
infusion), intramuscular, subcutaneous, intraperitoneal and
others
-
- Animal species: mice, rats, guinea pigs, hamsters, rabbits,
dogs .and cynomolgus monkeys coming soon!
-
- Animal species: rat and rabbit
-
- Tissue and Slide Preparation
-
- QA of Scanned Slides, Pathology Consultation and Evaluation by
Board-Certified Pathologist
Global Toxicology Services
- 24.
- QPS-CTPS is able to provide you a broad panel of in-house
conducted genotoxicity tests
-
- In Vitro mouse lymphoma assay
-
- Sister chromatid exchange assay
-
- Chromosome aberration assay
-
- Micronucleus assay in CHO cells
- Cell Transformation Assay
-
- In Vitro cell transformation assay
Global Toxicology Services
- 25.
- QPS-CTPS is able to provide you with this high-quality niche
service which primarily involves
- the toxicity testing of medical devices
- Acute Systemic Toxicity Test
- Intracutaneous Irritation Test
Global Toxicology Services
- 26.
- QPS-CTPS is able to provide you with other high-quality niche
services which primarily
- involves the toxicity testing of dermatological and cosmetic
products
- Skin Sensitization Testing
-
- Animal species: guinea pig
Global Toxicology Services
- 27. Slide Deck Navigator
- Global Toxicology Services
- Global Bioanalytical Services
- Global Translational Medicine Services
- Global Early Stage Clinical Development Services
- Global Late Stage Clinical Development Services
- 28.
- helping you navigate your way through the measurement of your
drug
- 29. Global Bioanalytical Services
- QPS is a global leader in bioanalysis for both small and large
molecules
- Small molecules using mass spectrometric techniques
- Large Molecules - using ligand binding assay techniques
- Global coverage of bioanalytical services with local presence
in North America, Europe, and Asia
-
- Specialists (>150 technical staff)
-
- State-of-the-art equipment (API5500Q, API 5000, UPLC-MS/MS,
ICP-MS, MSD, Gyros)
-
- Capabilities: LC-MS/MS, ICP-MS, LC-UV, LC-Flu, LC-ECD, LC-RFD,
LBA, Hybridization-ELISA
- Extensive validated assay list (> 750 assays and
growing)
- Rapid assay development, validation, sample analysis
- Supporting a full range of development from Preclinical to Late
Stage Clinical programs
- Immunogenicity & Neutralizing Antibody Activity
Assessment
- Central Lab Services: Sample Logistics / Sample Repository /
Preparation and Distribution of Sampling Kits
- 30. Global Bioanalytical Services
- QPS is a global leader in bioanalysis for small molecules and
is able to analyze samples coming from
- different types of studies, containing a wide variety of
compound structures and biological matrices
- Bioanalytical Method Development & Validation
- Sample Analysis for different evaluation purposes:
-
- Pharmacokinetic (PK) screening
-
- Toxicokinetic (TK) studies
-
- Clinical PK/Bioavailability studies
-
- Therapeutic drug monitoring studies
-
- Drug-drug interaction studies
- Sample Analysis of different compound structures:
-
- Oligonucleotides Analysis
- Sample Analysis in different biological matrices:
- 31. Global Bioanalytical Services in max. 10 slides (slide 3)
- Large Molecule ImmunoBioanalysis
- QPS is a global leader in bioanalysis for large molecules and
is able to analyze samples coming from
- different types of studies, containing a wide variety of
compound structures and biological matrices
- Bioanalytical Method Development & Validation
- Sample Analysis for different evaluation purposes:
-
- Pharmacokinetic (PK) screening
-
- Toxicokinetic (TK) studies
-
- PK/Bioavailability studies
-
- Therapeutic drug monitoring studies
-
- Drug-drug interaction studies
- Immunogenicity monitoring using four-tier approach:
-
- Confirmatory (immunodepletion)
-
- Titer assessment (quantification)
-
- Cell-based neutralizing antibody detection
- 32. Global Bioanalytical Services
- Elemental Analysis in Biological Matrices
- QPS is a unique provider of GLP trace and ultratrace elemental
analysis by ICP-MS, a detection
- technique which is increasingly being applied for studying the
pharmacokinetics, metabolism
- and pharmacodynamics of metal-containing and
non-metal-containing analytes in
- preclinical and clinical studies
- Bioanalytical applications that have been developed using
ICP-MS at QPS include but are not
- Platinum (Pt) in plasma and urine by ICP-MS for supporting
clinical studies with platinum-based chemotherapies
- Platinum (Pt) in plasma and urine by LC-ICP-MS for the
metabolite profiling of a new investigational platinum
compound
- Gadolinium (Gd) in plasma and urine by ICP-MS for supporting
clinical studies with MRI contrast agents and formulations
- Magnesium (Mg), Calcium (Ca), and Phosphate (P) in food and
feces for supporting a mass balance study of a new phosphate
binder
Transferrin Vitamin B12
- 33. Global Bioanalytical Services
- QPS believes strongly in this novel bioanalytical application
of LC-MS/MS and can show you some
- Bioanalytical Method Development and Validation, and Sample
Analysis
- 34. Global Bioanalytical Services
- QPS Delaware GLP Facility Newark, Delaware, USA
- QPS Delaware is a well-established high quality, cost-effective
sourcing solution for the
- analysis of PK and PD samples coming from preclinical and
clinical studies conducted in
-
- 27 (25 Sciex API 4000 and 2 Sciex API 5000)
- Large Molecule ImmunoBioanalysis
-
- Capability in PK, Immunogenicity, NAb assay, and
biomarkers
- Hundreds of validated methods (DDI CoMeds) available Complete
list available on website http://www.qps-usa.com/
- WATSON LIMS System v 6.4 (WATSON v7.4.1 Coming Soon!)
Gyrolab Automated Immunoassay Workstation
- 35. Global Bioanalytical Services
- QPS Netherlands GLP Facility Groningen, the Netherlands
- QPS Netherlands is a well established high quality,
cost-effective sourcing solution for the
- analysis of PK and PD samples coming from preclinical and
clinical studies conducted in
-
- 8 Triple Quadrupoles Mass Spec ( API 5500Q, 4000, 3000)
- Large Molecule ImmunoBioanalysis
-
- Capability in PK, Immunogenicity, NAb assay, and
biomarkers
- Elemental Spectrometry (ICP-MS)
-
- ICP-MS, for elemental analysis in pharmacology, toxicology and
product testing
-
- LC-ICP-MS, for identification and quantification of unknown
metabolites from in-vitro and in-vivo drug metabolism studies
-
- Many oncology (platinum) applications
- Hundreds of validated assay methods (DDI CoMeds) available
Complete list available on website http://www.qps-usa.com/
- LabVantage Sapphire LIMS System
- Logistically closely linked to the phase I unit to enable fast
turnaround of plasma concentration data of laboratory biomarkers
and drug candidates during the conduct of first-in man programs
(SAD, MAD), human mass balance studies, and trials with instable
compounds
- 36. Global Bioanalytical Services
- QPS-Bioserve GLP Facility Hyderabad, India
- QPS-Bioserve is a high quality, cost-effective sourcing
solution for the analysis of
- PK samples coming from bioequivalence studies conducted by
QPS-Bioserves own phase I
- Unit and from clinical studies performed in India
-
- 7 Triple Quadrupoles Mass Spec (2 Sciex API 3200 and 5 Sciex
API 4000)
- Hundreds of generic methods available Complete list available
on website http://www.qps-usa.com/
- QPS-Bioserve has a dedicated and experienced Pharmacokinetics
& Statistics team, with expertise in the application and
presentation of PK and statistical principles, critical for
successful approval of generic product submissions:
-
- Study design, sample size and statistical power estimation
-
- In Vitro - In Vivo Correlation (with Pharsight IVIVC toolkit
software)
-
- WinNonlin for PK analysis and SAS for statistical analysis
-
- Final Report submissions in E3/ CTD format
- 37. Global Bioanalytical Services
- QPS Taiwan GLP Facility Taipei, Taiwan
- QPS-Taiwan is a high quality, cost-effective sourcing solution
for the analysis of
- PK samples coming from bioequivalence studies conducted by
QPS-Bioserves own Phase I
- Unit and from clinical studies performed in Asia
-
- 4 Triple Quadrupoles Mass Spec (4 Sciex API 4000)
- Large Molecule ImmunoBioanalysis
-
- Capability in PK, Immunogenicity, Nab assay, and
biomarkers
- Hundreds of generic methods available Complete list available
on website http://www.qps-usa.com/
- WATSON LIMS System v 6.4 (WATSON v7.4.1 Coming Soon!)
- 38. Slide Deck Navigator
- Global Toxicology Services
- Global Bioanalytical Services
- Global Translational Medicine Services
- Global Early Stage Clinical Development Services
- Global Late Stage Clinical Development Services
- 39.
- helping you navigate your way through the efficacy of your
drug
- 40. Global Translational Medicine Services
- As an experienced provider of translational medicine services,
QPS offers
- solutions to help guide drug development teams at various
stages, including patient
- stratification, toxicity prediction, evaluation of PK profiles,
dose determination, and treatment
-
- PD protein or biochemical markers
-
- Various biomarker assay platforms (ELISA, Immulite , Bioplex ,
MSD Imager 6000 ECL, LC-MS/MS, LC-ECD)
-
- Cell-based & functional assays
-
- Western Blot analysis & quantification
-
- Radioligand binding assay
-
- On-site cell stimulation and cytokine biomarker panel
evaluation
-
- DNA isolation and banking
-
- Genotyping (SNPs, insertions, deletions, copy numbers,
etc.)
-
- CpG methylation quantification
-
- RNA isolation & expression profiling (qRT-PCR)
- 41. Global Translational Medicine Services
- QPS offers laboratory biomarker services for many different
therapeutic areas
Adrenal/Pituitary Disorders Diabetes / Lipid Metabolism /
Carbohydrate Metabolism Reproductive Endocrinology Allergy
Gastrointestinal Thyroid Function Alzheimers Disease
Hemostasis/Angiogenesis Anemia Infectious Disease Autoimmune
Disease Inflammation / Immune Status / Cell Response Bone Disease /
Metabolism Oncology (Tumor/Neoplasia Markers) Cardiac Markers
Phenotypic Markers of Drug Metabolism Cell Response Renal Toxicity
and Function
- 42. Global Translational Medicine Services
- Genotyping services are offered by QPS offers to help
individualize disease therapies
- Nucleic Acids Isolation (DNA & RNA) and Banking
- Genotyping (SNPs, Insertions, Deletions, Copy numbers,
etc.)
- CYP450 Genotyping Assays (CYP2B6, CYP3A4, CYP3A5, CYP2C9,
CYP2C19, CYP2D6 genotyping panels)
- Genotyping Assays for Other Drug Metabolizing Enzymes (NAT1,
NAT2, UGT1A1, CDA)
- Genotying Assays for Transporters (ABCG2, SLCO1B1)
- Genotyping Assays for Oncology (BRAF, KRAS, PIK3CA)
- Genotyping Assays for Alzheimers Disease (ApoE, PPP3R1)
- Genotyping Assays for Warfarin Therapy (CYP2C9*2, CYP2C9*3, and
VKORC1 (-1639 G>A))
- Gene Expression Profiling in various matrices (qRT-PCR)
Pyrosequencing
- 43. Global Translational Medicine Services
- Immunogenicity/Anti-Drug Antibody Testing
- QPS is an expert in immunogenicity/ADA testing and has all the
necessary knowledge and
- assays technologies at its disposal
- QPS has supported 15 biologic drug development programs for 10
sponsors (11 proteins and 4 therapeutic antibodies) for which over
50 studies were performed.
- Anti-Drug-Antibodies (Screening, Confirmation, and
Titering)
- Critical Reagent Labeling
- Cell Based Neutralizing Antibody (NAb) Assays
- Cell Banking and Maintenance
- Custom Method Development and Optimization
Meso Scale Discovery
- 44. Global Translational Medicine Services
- Neutralizing Antibody Assays:
- QPS is an expert in NAb testing and is able to apply its
extensive knowledge and application of
- new assay technologies to your benefit
- Since 2002 > 40 Studies conducted for 7 Sponsors
- Cell-Based Functional Assays, e.g. cell viability assay
- Other Functional Assays, e.g. activity assay
- 45. Global Translational Medicine Services
- Novel Biomarker Assay Development
- QPS is a frontrunner in adopting new assay technologies for
biomarkers
- Various Technology Platforms (ELISA, BioPlex, Immulite, MSD
ECL, Gyrolab)
- Multiplexing Genetic Markers (CYP450 TaqMan or Affymetrix DMET
genechips)
- Pharmacodynamic (PD) Assays
- On-Site Cell Stimulation and Biomarker Analysis
- Fit-For-Purpose Biomarker Assay Development and Validation
(various matrices)
Luminex
- 46. Global Translational Medicine Service
- QPS scientists and laboratory technicians are used to work and
have many validated assays on
- many different assay technology platforms
- Pyrosequencing Technology Platform
- Affymetrix GeneChip Microarray System
- TaqMan Real-Time PCR System
- Gradient Gel Electrophoresis (GGE)
- HPLC/UHPLC/UV/Fluorescence/ECD
- Meso Scale Discovery (MSD) ECL Platform (SECTOR PR100 and
Imager 6000)
- Radioligand Binding Assay (SPA)
- 47. Slide Deck Navigator
- Global Toxicology Services
- Global Bioanalytical Services
- Global Translational Medicine Services
- Global Early Stage Clinical Development Services
- Global Late Stage Clinical Development Services
- 48.
- Early Stage Clinical Development
- helping you navigate your way through the complex challenges of
the early development of your drug
- 49. Global Early Stage Clinical Development Services
- QPS is a global leader in Phase 1 studies
- QPS has one of the worlds largest Phase 1 site offerings with
400 Phase I beds on three continents:
- QPS offers a broad spectrum of early phase study types:
-
- First-in-Man Programs (SAD + MAD + FE + CYP450 Interaction) -
the Netherlands
-
- Human Mass Balance studies - the Netherlands
-
- Microdosing studies - the Netherlands
-
- Clinical PK/PD studies - the Netherlands, Taiwan, India and
USA
-
- Imaging (PET, fMRI) studies - the Netherlands
-
- Bioavailability/ANDA studies - Taiwan, India and USA
-
- Bioequivalence/ANDA studies - Taiwan, India and USA
-
- Vaccine studies - Taiwan, India and USA
-
- Cardiac Safety/Thorough QT/QTc studies - USA
-
- Drug-Drug Interaction studies - the Netherlands, Taiwan, India
and USA
- 50. Global Early Stage Clinical Development Services
- Full-Service Early Stage CRO
- QPS is a full service early stage CRO that is not only capable
of providing the clinical conduct of
- your Phase 1 study but has the ability to provide the front and
back end services as well
- Review of Preclinical Data
- Design and Preparation of the Trial
- Clinical Project Management
- Preparation of the Study Protocol, Informed Consent, and Case
Report Forms
- Bioanalysis/Biomarker Assays
- Conduct PK/PD and/or Pop PK/PD Data Analysis and Modeling
- Prepare and publish Fully Integrated Clinical Study
Reports
- 51. Global Early Stage Clinical Development Services
- QPS is not only capable of conducting phase 1 studies for you
in specialty and patient
- populations but QPS is capable of doing the additional
measurement and interpretation of
- therapeutic-specific biomarker data as well
Adrenal / Pituitary Disorders Diabetes / Lipid Metabolism /
Carbohydrate Metabolism Reproductive Endocrinology Allergy / Asthma
/ COPD Gastrointestinal Thyroid Function Alzheimers Disease
Hemostasis / Angiogenesis Anemia Infectious Disease Autoimmune
Disease Inflammation / Immune Status / Cell Response Bone Disease /
Metabolism Oncology (Tumor / Neoplasia Markers) Cardiac Markers
Phenotypic Markers of Drug Metabolism Cell Response Renal Toxicity
and Function
- 52. Global Early Stage Clinical Development Services
- QPS-Biokinetic Springfield, Missouri, USA
- QPS-Biokinetic is ideally suited to conduct a wide variety of
phase I studies, especially when
- substantial numbers of volunteers need to be recruited in
record breaking time
- 5 Clinical Units on one Campus
- Over 900 studies completed since 1994
- Clinical Staff Experience
-
- 8+ years average length of employment
-
- Less than 3% staff turnover rate
- Over 20,000 active subjects database
-
- Birth Control and Birth Control Nave
- 53. Global Early Stage Clinical Development Services
- QPS-Bioserve Hyderabad, India
- QPS-Bioserve is a full service Phase I CRO with a long list of
regulatory approvals for generic
- products that have been tested at this site
- Full-service CRO, all aspects of study (from study design to
final report generation) are conducted in-house
- ISO 9001:2008 certified organization
- Approved by the Drugs Controller General of India (DCGI)
- Audited by the US-FDA in March 2008 & July 2009 (no
483s)
- Inspected by UK MHRA and WHO in 2010
- Over 550 conventional BA/BE studies conducted for various
regulatory agencies (130 are pivotal studies)
- 20 products successfully approved by US-FDA
- Clinical End Point Studies: QPS-Bioserve has experience in
using PD end points or other acceptable surrogate parameters to
establish bioequivalence for products (e.g. locally acting/topical
preparations) for which it is impossible to use PK endpoints to
establish bioequivalence. Examples: Sucralfate (suspension),
Pentosan Polysulfate (capsules), Adapalene (gel)
- Pharmacoscintigraphic Imaging
- NCE PK studies like Food Effect, Dose Proportionality and
Drug-Drug Interaction
- 54. Global Early Stage Clinical Development Services
- QPS Taiwan Taipei, Taiwan
- QPS Taiwan is a full service Phase I unit with a long list of
regulatory approvals for locally
- manufactured generic products
- Full-service CRO, all aspects of study (from study design to
final report generation) are conducted in-house
- Bioavailability / Bioequivalence Studies
-
- Healthy Normal Populations
-
- PK in Cancer Patient Population
-
- Scaled Average Bioequivalence
- Conventional BA/BE studies conducted for various regulatory
agencies
- More than 40 products successfully approved by Taiwan FDA
- 55. Global Early Stage Clinical Development Services
- QPS Netherlands Groningen, the Netherlands
- QPS Netherlands is ideally suited to conduct your FIM and more
complex phase I programs
- Over 100 studies completed: 20 first-in-man programs (of which
12 with biologics); 7 PET studies; 6 Oral Contraceptive (OC)
interaction studies
- 2 FDA audits (1 in 2009 and 1 in 2010)
- Fast and easy access to top-notch medical, clinical
pharmacological , medical and scientific expertise
- Parallel submission to Competent Authority (CCMO) and local
Ethics Committee (EC) resulting in Clinical Trial Approval within
14 days! Substantial amendments: 48 h turnaround time; Dose
escalations: 24 h turnaround time
- Logistically closely linked to the bioanalytical laboratory to
enable fast turnaround of plasma concentration data of laboratory
biomarkers and drug candidates
-
- Multi-purpose Umbrella Protocols (SAD + MAD + food effect +
CYP450 fenotyping) adaptive designs with flexible dosing escalation
schemes
-
- Female Health Care (OC interaction studies, Lactation studies
and Fertility studies)
-
- Validated neuropathic (capsaicin) and acute (M3 extraction)
pain models
-
- Imaging (PET, fMRI) studies
-
- (Continuous) CSF sampling in HV
-
- Radiolabel (14C) Mass Balance studies
- 56. Slide Deck Navigator
- Global Toxicology Services
- Global Bioanalytical Services
- Global Translational Medicine Services
- Global Early Stage Clinical Development Services
- Global Late Stage Clinical Development Services
- 57.
- Late Stage Clinical Development
- helping you navigate your drug all the way across the finish
line
- 58. Global Late Stage Clinical Development Services
- Widely recognized for achieving high-quality study data and
high patient enrollment rates, QPS
- site management & monitoring teams bring you years of
experience
- Phase I-IV Project Management
- Phase II-IV Study Management
- Clinical Trial Monitoring (incl. Phase I)
- Clinical Trial Logistics and Supplies
- In- and outsourcing of clinical professionals
- 59. Global Late Stage Clinical Development Services
- Program, Project & Study Management
- Apart from stand-alone clinical research activities, QPS is
also able to manage your
- entire clinical drug development program
-
- Design of clinical program
- Budget, Resource and Timeline Control
- Experience with the following therapeutic indication areas:
Allergy, Cardiology, Metabolic diseases, CNS, Vascular Surgery,
Oncology, Multiple Sclerosis, Gastroenterology, Hematology, Genetic
Diseases, Radiology
- 60. Global Late Stage Clinical Development Services
- Site Management & Monitoring
- QPS is able to take a lot of clinical research activities away
from you
-
- train-the-trainer sessions
- (Remote) Data Quality Review
- Site Audit and/or Qualification
- Essential Document Collection
- 61. Global Late Stage Clinical Development Services
- State-of-the-art clinical trial management and electronic data
capture systems enable QPS to
- deliver first rate data management services
- Streamlined clinical information capabilities between QPS
Sites/Branches
- Clinical Database (Oracle Clinical and OpenClinica)
- Experience with the following therapeutic indication areas:
Vascular Surgery, Metabolic diseases, Cardiology, Vaccins, CNS,
Observational Studies (Phase 4)
- 62. Global Late Stage Clinical Development Services
- State-of-the-art clinical trial management and electronic data
capture systems enable QPS to
- deliver first rate biostatistics services
- Data Analysis for Late Stage Clinical Studies
- Exports of Tables, Figures and Listings (TFLs)
- PK / PD Analysis (including Pop PK)
-
- Pharmacokinetic and statistical consultancy
-
- Study design including optimization of PK sampling and power
evaluation of subject size
-
- Non-compartmental and compartmental PK modeling
-
- Population pharmacokinetics
- Experience with the following therapeutic indication areas:
Vascular Surgery, Metabolic Diseases, Cardiology, CNS, Various
Phase I
- 63. Global Late Stage Clinical Development Services
- QPS can take care of all your medical writing needs
- IMPD (Investigational Medicinal Product Dossier)
- Final Clinical Report (CTD or eCTD)
- Experience with the following therapeutic indication areas:
Vascular Surgery, Metabolic diseases, Cardiology, Immunology, CNS,
MS, Allergy and Pulmonary Diseases
- 64. Global Late Stage Clinical Development Services
- Temporary Staffing/Flexible Sourcing Solutions
- QPS employees can be outsourced and be brought temporarily on
to your own drug
- Clinical Research Associates
- Clinical Research Coordinators
- Clinical Project Managers
- Clinical Pharmacokineticists
- Clinical Research Trainers
- 65. Global Late Stage Clinical Development Services
- QPS employees have dealt with a lot of therapeutic areas for
significant periods of time
- Adrenal / Pituitary Disorders
- Immunology / Autoimmune Disease / Rheumatoid Arthritis
- Alzheimers Disease / CNS Disorders
- Inflammatory Diseases / Immune Status / Cell Response
- Bone Disease / Metabolism
- Oncology / Tumors / Neoplasia
- Diabetes / Obesity / Lipid Metabolism / Carbohydrate
Metabolism
- Female Health Care / Gynecological Endocrinology / Reproductive
Endocrinology
- Gastrointestinal Disorders
- 66. Why QPS?
- QPS will help you navigate your way through the complex
challenges of the
- development of your drug.and while navigating your way, you
will enjoy having.
- Direct access to QPS people's minds!
-
- Direct access to key personnel
-
- Direct access to a vast amount of drug discovery &
development experience
- Direct access to QPS people's hearts!
-
- Focus on long-term professional customer relationships
- Direct access to QPS people's hands!