Comprehensive Discovery and Preclinical ADME Studies
Drug Metabolism: Metabolite Profiling & Identification in Animals & Humans
Biomarkers and Cell-based Assays
Protein, Biochemical, and Pharmacogenomics/Pharmacogenetics
Phase I Clinical Pharmacology/PK/PD
Quality Performance Service
91% of the time QPS has been the low cost provider
In cases where the sponsor has shared competitor’s cost information or from participation on online auctions.
Large subject database
Lower recruiting costs
Lower Cost of Living
Lower direct business costs
Lower subject stipends
Single location efficiencies (staffing, operations, logistics)
Experienced, flexible staff
Recent Examples of Performance
1242 Subjects enrolled in 4 weeks
Aged 40 to 90
80% over the age of 60 per protocol
16,160 Samples processed and shipped on time
90 postmenopausal subjects recruited in 4 weeks
Conducted over holiday weekend on time
7 Studies in same compound
116 to 140 subjects each
All subjects naïve to compound
Returns out to 3 months
Single IM injection
Commitment to Customer!
Highly experienced staff works to obtain results quickly, on time and on budget
Work with you to meet your objectives
Minimize your costs
Recruit and start your study fast and full
We keep you updated every step of the way
Your Success is Our Success!
"At QPS Bio-Kinetic, you can expect the highest quality and reliable services for your Phase I studies. QPS Bio-Kinetic employs dedicated and experienced people to perform your studies.”
— Sheela M.
Associate Director, QA
“ I have found [QPS] Bio-Kinetic to be a highly professional organization with the ability to be flexible and responsive to the needs of the clinical program.”
— Nicholas P.
Associate Director, Early Development
“ QPS Bio-Kinetic has the most experience of any Phase I unit in the industry. They have highly-trained, long-term personnel who are not only technically expert but also understand the importance of your study. They have the equation for guaranteed success. I always recommend QPS Bio-Kinetic to my colleagues".
— Rick S.
“ Our company has placed studies at QPS Bio-Kinetic for over 10 years, including the key pharmacokinetic study assessing Drug X components, as well as many of our postmenopausal women, Drug Y pilot bioavailability studies, and all of our pivotal bioequivalence studies.
One wouldn't normally think of Springfield, Missouri, as a major CRO site, but the types of subjects they continually enroll are just solid, middle-class citizens with excellent retention for a clinical study.
For our pivotal Drug Y BE studies, we routinely enroll over 70 postmenopausal women subjects and no other site in this country or EU can enroll and dose them in one day, as can be done at QPS Bio-Kinetic. QPS Bio-Kinetic is planned as a site for all future Drug Y BE studies. Having served on the Drug Y team and been involved in many management presentations, there is simply no way we can make our timelines and meet our project objectives without using this site.”
— Phil M.
Assistant VP of Clinical Pharmacology
“ When we look for clinical research sites, we prefer smaller organizations that understand the unique pressures of optimizing speed, quality and price we face as a small company. We demand they be trustworthy, can perform the protocol as directed, are able to communicate study progress and are focused on client service.
I have worked with QPS Bio-Kinetic for many years, in particular for BE/BA, DDI and cardiac safety studies. Because of their experienced staff, training and detailed processes, I am confident I can count on qualified study participants, quality data and PK samples to be drawn on time.
I trust QPS Bio-Kinetic to tell me when they don’t have the capacity to perform my study according to my specifications or timeline. Based on their history of meeting my expectations and my trust in the QPS Bio‑Kinetic staff, QPS Bio-Kinetic has become my first choice as a clinical site.”
— Jim M.
Senior Director, Clinical Development
Ligand Binding Assay
GLP Compliant –
FDA Crystal City Guidelines, Pharma Research 2006 White Paper
( 3 H, 14 C, 32 P, 33 P, 35 S, 45 Ca, 51 Cr, 90 Y, 99m Tc, 111 In, 125 I, 188 Re)
DEA Registration for Scheduled Controlled Substances (Schedule I – V)
CDC Permit – Export/Import Primate samples
Federal Fish & Wildlife Permit
Quality You Expect Service You Trust Turnaround You Need
Approved by Taiwan’s Department of Health as a qualified CRO
QPS Taiwan / QPS(US)
Same Set of SOPs
Same Set of Laboratory Procedures
Same High Quality Standard
NCEs and non-proprietary compounds for US, European, and Local Pharmaceuticals and Biotechnology Companies
Generic compounds for local Generic Companies
Pilot BA/BE Studies in collaboration with the Taipei Clinical Research Center (part of Taipei Medical University Hospital)
Discovery Dog PK Studies with our in-life Affiliate – DCB Taiwan
QPS Taiwan Services
Design and Perform Studies
Schedule Studies as per Protocol
Review Sample Inventory
Follow-up with sponsor & study site if discrepancy occur
Plot data to reveal possible trend
Flag discrepancy for Sponsor review
Discovery ADME Screen
Drug Candidate Selection Studies
IND/NDA-filing ADME Studies
Design, Manage, and Perform Studies
Review, Prepare Study Reports, and Preclinical ADME Summary for IND submission
Process Map: Clinical with Bioanalysis/Biomarker RFP Clinic plus Bioanalysis Biomarkers needed? Receiver Review RFP Generate Proposal, Internal Review/Approval, f/b Issuance to Sponsor Yes Receiver Distribute RFP to relevant Proposal Distribution List No Individual P&L Center Generate Proposal(s) f/b Internal Review QPS Bio-Kinetic – Combine Proposals into a Single QPS Proposal Proposal Accepted? End. Ask for Feedback No Yes Project Manager Needed? Decide on Project Manager, Study Monitor, Principle Investigator(s) Yes QPS Bio-Kinetic and QPS Bioanalysis parallel Internal Process QPS Bio-Kinetic – Conduct the clinical phase QPS Bio-Kinetic – Ship Clinical Samples QPS Bioanalysis/Biomarker – Receive Clinical Samples QPS Bio-Kinetic – Internal Process & Clinical Summary Generation QPS Bioanalysis/Biomarker – Conduct Sample Analysis QPS Bioanalysis/Biomarker – Internal Process & Report Generation QPS WHO – Combine Both Reports into a Single QPS Report Report Issuance for Sponsor Review Sponsor send RFP to QPS (any organization) Internal Review/Approval, f/b Issuance to Sponsor Decide on Study Monitor, and Principle Investigator(s) No