A well-conceived and executed IND-enabling preclinical program and completion of early clinical trials will provide you with a detailed assessment of your drug candidate including the most cost-effective and timely pathway to filing an IND and completion of the “proof-of-concept” studies. During execution of your IND-enabling program you will benefit from QPS’ operational strengths, strong scientific/regulatory pre-IND/IND support and drug development experience.
Partnering with QPS for a well-conceived and executed IND-enabling preclinical program will provide you with a detailed
assessment of your drug candidate and the most agile, flexible and timely pathway to filing an IND.
QPS DMPK provides a dedicated team of senior scientists to help select, design and conduct the appropriate ADME studies
for your specific compounds and therapeutic targets.
Working with QPS DMPK is a collaborative and consultative
endeavor that also incorporates our operational effectiveness
and dedication to customer service.
Anthony Presentation DIA Florida Ctd Nov2007AKTaylor
Creating a business process that is accurate, predictable, and capable of
meeting the changing needs for disclosing information about clinical trials
in multiple study registries and results databases is difficult. Companies
need to leverage their current clinical trial process, determine if the disclosure
steps will be centralized or decentralized, determine how much to
leverage technology, and decide whether, and how, to use outside
resources. During this session, we will hear how a large pharma, a small
biopharmaceutical company, and a device company developed their clinical
trial disclosure business process.
Partnering with QPS for a well-conceived and executed IND-enabling preclinical program will provide you with a detailed
assessment of your drug candidate and the most agile, flexible and timely pathway to filing an IND.
QPS DMPK provides a dedicated team of senior scientists to help select, design and conduct the appropriate ADME studies
for your specific compounds and therapeutic targets.
Working with QPS DMPK is a collaborative and consultative
endeavor that also incorporates our operational effectiveness
and dedication to customer service.
Anthony Presentation DIA Florida Ctd Nov2007AKTaylor
Creating a business process that is accurate, predictable, and capable of
meeting the changing needs for disclosing information about clinical trials
in multiple study registries and results databases is difficult. Companies
need to leverage their current clinical trial process, determine if the disclosure
steps will be centralized or decentralized, determine how much to
leverage technology, and decide whether, and how, to use outside
resources. During this session, we will hear how a large pharma, a small
biopharmaceutical company, and a device company developed their clinical
trial disclosure business process.
Innovation is hard. It is hard to come up with new ideas and get out of the day to day grind. In this presentation Nick Coster describes how to use Science Fiction to explore the world of the impossible to find major leaps in customer value that can be used as inspiration for today's product development.
These are four proven formats for your product roadmap, including:
- A traditional customer-facing roadmap
- A lean customer-facing roadmap
- An internal coordination roadmap for one product
- An internal product portfolio roadmap
Use the right template for yoru situation to build your own roadmap.
State of Corporate Venturing - A VC perspective on Markets and OutlookThomas Grota
The markets have changed, unicorns are becoming an obstical to have in your portfolio and comporations are pushed to be active in investing and partnering. 5 take aways on how to survive and generate value as a corporate VC in 2016.
FDA 2013 Clinical Investigator Training Course: Preparing an IND Application:...MedicReS
FDA 2013 Clinical Investigator Training Course: Preparing an IND Application: Clinical Considerations for Cell and Gene Therapy Products
Rachel Witten, M.D., (CBER)
Case studies How Do Architects Get Paid3dartrender
This is a case study presentation on the Method of payment for the architects regular service. Presenting a computation of the percentage fee based on the construction cost and broken down into 4 stages. Upon completion of each stages, the professional fee is distributed accordingly
Thanks to its combination of clinical pharmacology and bioanalytical services, QPS Netherlands has broad experience in performing dose-escalating (first-in-man) and drug-drug interaction studies with rapid turnaround of time-sensitive PK and biomarker samples.
Blueprints to blue sky – analyzing the challenges and solutions for IHC compa...Candy Smellie
Manual assessment of biomarker expression is associated with significant inter- and intra reader variability. In some cases there are also limitations when it comes to sensitivity and specificity of manual biomarker assessment.
In one example to the left, the “pure” contribution of inter-reader variability associated with Ki67 assessment was quantified across 20 tumors and 126 participating labs. In that study, it was demonstrated how image analysis can be used to significantly reduce inter-reader variability.
In a another study, the National Danish Validation study of Her2, it was demonstrated how improved sensitivity/specificity of quantitative HER2 protein expression wrt gene amplification lead to significant cost savings in reflex testing.
By automating aspects of stain quality control, it will become scalable to he point where EQA organizations may be able and willing to offer more frequent – perhaps even on-demand – proficiency testing and calibration services.
It is possible that objective and quantitative standards will contribute to improve compliance with protocol recommendations.
In clinical multi-center trials it will be easier to standardize and monitor data from each center.
And it is our hope tha larger diagnostic pathology labs will be able to benefit from such a method by closely monitoring drift in staining quality for biomarkers.
Innovation is hard. It is hard to come up with new ideas and get out of the day to day grind. In this presentation Nick Coster describes how to use Science Fiction to explore the world of the impossible to find major leaps in customer value that can be used as inspiration for today's product development.
These are four proven formats for your product roadmap, including:
- A traditional customer-facing roadmap
- A lean customer-facing roadmap
- An internal coordination roadmap for one product
- An internal product portfolio roadmap
Use the right template for yoru situation to build your own roadmap.
State of Corporate Venturing - A VC perspective on Markets and OutlookThomas Grota
The markets have changed, unicorns are becoming an obstical to have in your portfolio and comporations are pushed to be active in investing and partnering. 5 take aways on how to survive and generate value as a corporate VC in 2016.
FDA 2013 Clinical Investigator Training Course: Preparing an IND Application:...MedicReS
FDA 2013 Clinical Investigator Training Course: Preparing an IND Application: Clinical Considerations for Cell and Gene Therapy Products
Rachel Witten, M.D., (CBER)
Case studies How Do Architects Get Paid3dartrender
This is a case study presentation on the Method of payment for the architects regular service. Presenting a computation of the percentage fee based on the construction cost and broken down into 4 stages. Upon completion of each stages, the professional fee is distributed accordingly
Thanks to its combination of clinical pharmacology and bioanalytical services, QPS Netherlands has broad experience in performing dose-escalating (first-in-man) and drug-drug interaction studies with rapid turnaround of time-sensitive PK and biomarker samples.
Blueprints to blue sky – analyzing the challenges and solutions for IHC compa...Candy Smellie
Manual assessment of biomarker expression is associated with significant inter- and intra reader variability. In some cases there are also limitations when it comes to sensitivity and specificity of manual biomarker assessment.
In one example to the left, the “pure” contribution of inter-reader variability associated with Ki67 assessment was quantified across 20 tumors and 126 participating labs. In that study, it was demonstrated how image analysis can be used to significantly reduce inter-reader variability.
In a another study, the National Danish Validation study of Her2, it was demonstrated how improved sensitivity/specificity of quantitative HER2 protein expression wrt gene amplification lead to significant cost savings in reflex testing.
By automating aspects of stain quality control, it will become scalable to he point where EQA organizations may be able and willing to offer more frequent – perhaps even on-demand – proficiency testing and calibration services.
It is possible that objective and quantitative standards will contribute to improve compliance with protocol recommendations.
In clinical multi-center trials it will be easier to standardize and monitor data from each center.
And it is our hope tha larger diagnostic pathology labs will be able to benefit from such a method by closely monitoring drift in staining quality for biomarkers.
An ever-evolving regulatory environment makes navigating gene therapy products through to clinic much more complicated than a traditional biologic. While manufacturing platforms and regulatory requirements for testing of antibodies has existed for decades, gene therapy platforms and their testing requirements are changing rapidly with the progression of products toward commercialization.
Discovery on Target 2014 - The Industry's Preeminent Event on Novel Drug TargetsJaime Hodges
Cambridge Healthtech Institute's 12th Annual Discovery on Target will showcase current and emerging “hot” targets for the pharmaceutical industry, October 8 – 10, 2014 in Boston, MA. Spanning three days, the meeting will bring together more than 900 global attendees, including scientists/technologists, executives, directors, and managers from biopharma, academic, and healthcare organizations. In 2014 the event is comprised of 14 conference tracks which include Epigenetic Readers, Ubiquitin Proteasome, Big Data Discovery, GPCR Drug Discovery, RNAi-Screens-Functional-Genomics, PPI Targets, Protein-Targets, Histone-Methyltransferases-Demethylases, Drug Transporters, Maximizing Efficiency, GPCR Therapeutics, Genomics Screening, Cancer Metabolism and Membrane Production. The 2014 event will offer 200+ scientific presentations across 14 conference tracks, 1 Symposium and 15 conference short courses, 40+ interactive breakout discussion groups, an exhibit hall of 40+ companies, and dedicated poster viewing and networking sessions.
ExL Pharma Clinical Trials Phase I and Phase IIa Conference Brochure: Phase 1...bryonmain
There is a pill or treatment for almost everything, or at least, that is how it seems. However, the amount of effort that goes into a pill or treatment before it is launched is extensive, expensive and often inefficient.
Efficiency and innovation go hand-in-hand with R&D and the development of clinical trials, however, FDA regulations and clinical trial standardization end up stifling these two key factors. This leads to drawn out processes that cost companies hundreds of millions of dollars before the drugs hit the market. Efforts have been made to increase efficiency in phase I/IIA with some companies changing their clinical trial manifestos to suit the available patient population at clinical sites, but more emphasis should be placed on creating more efficient processes for first in human studies by optimizing pharmacokinetics/pharmacodynamics, dosage selection, technological advancements to improve efficacy and structured patient mapping to increase successful trial and patient recruitment opportunities.
This program will give delegates the opportunity to share proven strategies between companies to help increase efficiency in this space and streamline processes to cut down costs. This event will bring together large and small companies and experts in this space to share best practices to decrease the financial drain theses phases have on the overall clinical trial budget. Life science corporations need the most up-to-date tools and practices to increase success by streamlining processes, sharing successful biomarker strategies, anticipating dosing quantities, and optimizing healthy or specialty patient recruitment and retention. Current strategies include patient mapping before organizing and setting up a clinical space, tailoring early phase clinical trials to patient populations, purchasing biological samples from collection companies, and trying to accelerate the process by submitting for breakthrough therapy designation.
Top Reasons To Attend
Identify Compound Development Strategies to Optimize Success in Clinical Trials
Learn Best Practices for Early Decision-Making Through Analysis of Biomarker Utility in Drug Development
Utilize Analytical Technology to Evaluate Multiple Configurations of a Small Molecule to Increase the Feasibility of Drug in Clinical Trials
Implement Adaptive Design in Proof of Concept Studies to Increase Efficiency, Decrease Time and Decrease Overall Cost
Explore the Seamless Development of Phase I to Phase II in Clinical Trials
NINE Case Studies and a Panel Session on Early Phase Clinical Trial Strategies
“Pharmaceutical Quality Matrices in determining overall state of Quality and ...Marcep Inc.
Introduction to Quality Matrices
•What is Quality metrics
Background&Glossary
•Modernization of Regulatory Oversight of Drug Quality and Promotion of Post-Approval Improvements
•Use of Quality Metrics by FDA for Risk-Based Inspection Scheduling and Prediction of Drug Shortages
Legal authority
•Records Associated with the Process Validation Lifecycle and PQS Assessment
•Authority to Inspect Records and Request in Advance of or In Lieu of an Inspection
The Use of Quality Metrics and Effect of Non-Reporting
•How FDA Intends to Use Quality Metrics
•Effect of Non-Reporting
Group Discussion:
Implementing Trending of Quality Indices in Your Organization
The importance of the right culture and people
• Role of leadership in trending of Quality Indices
• Developing anonline data base for Quality Indices
•Analysis, interpretation and reporting of Quality Indices
The Process Flow
• Establishing the ground rules, procedures, forms and mechanismfor data collection for Quality indices
• Determining responsibilities and roles for the implementation of trending of Quality Indices
Starting the Quality Indices Management Process
•Review of Quality Indices and Gap evaluation
•Preparation of Data bases for Data acquisition
•Collection data for completeness and Accuracy
•Processing and Reporting of Quality Metrics
Day Two
Reporting of Quality data and Calculation of Quality Metrics
• Who Reports and Who May Contribute to the Report
• Quality Metrics that FDA Intends to Calculate
• What Quality Data Would Be Reported
• How to Report Quality Data to FDA
Instructions for Quality Metric Data Submission
•Worksheet for Data Tables
•Product Specific Information
•Mandatory Data •ICH Q9
•Optional Metrics
Recognizing and Understanding the Trending of Quality Indices
Working Session, I:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis on a given data. Each group will present theresults of its analysis
Working Session II:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis and propose a Quality metric by using Risk Based approach for the specific set of data. The results of the analyses willbe shared in the class.
Complexities of Implementation Quality Metrics
•Overcoming the pitfalls
•Benefits and Risks
General Discussion and Questions
Whether your focus is on small molecules, proteins, bio-therapeutics, vaccines, or gene therapy, QPS provides a full range of bioanalytical solutions to support drug development from discovery through clinical development and filing.
At QPS, translational medicine brings together leading-edge technologies and pharmaceutical research and development experience to create a business service unit that works efficiently to advance your drug development program.
Our profound expertise in Neuroscience and two decades of experience in contract research result in a sustainable advantage for our customers. QPS offers you a sophisticated range of validated transgenic and non-transgenic in vivo and in vitro models to guarantee that your new chemical or biological compounds are profiled in depth.
The QPS Bioanalysis General presentation is a summary of our capabilities in Neuropharmacology, Toxicology, DMPK, Bioanalytical, Translational Medicine, and Dermal and Transdermal Preclinical services.
At QPS, CSF Sampling brings together leading-edge technologies and pharmaceutical research and development to reveal pharmacokinetic information about drug concentrations.
When your focus is Biotherapeutics, QPS’ Global Laboratories provide a full range of bioanalytical solutions to support immunogenicity evaluations during drug development from discovery through clinical development and filing.
QPS Missouri's Negative Pressure Room.
A negative pressure room uses lower air pressure than the
rooms surrounding it to allow outside air into the facility.
This traps and keeps harmful particles from leaving the
potentially contaminated area.
A well-conceived and executed preclinical and clinical
radiolabeled ADME program will provide you with a detailed
assessment of the total fate (mass balance, route, and rate of excretion,
tissue distribution, metabolic pathways, and identity and quantity of
metabolites) of your drug candidate to support regulatory submissions.
QPS Regulated Bioanalysis of Antibody Drug ConjugatesQPS Holdings, LLC
PK profiling reflects molecular complexity. Since 2001 QPS’ bioanalytical teams have contributed to ADC drug development,
supporting the filing of one of the first drug targeting
programs and continue to develop customized
strategies for novel conjugate molecules.
To support research and development in different stages of biopharmaceutical compounds and products, QPS offers biomarker services in different global competence centers using
a wide range of technology platforms to support programs in any therapeutic area. QPS biomarker capabilities range from small molecule analysis to whole cell characterization.
When your focus is small molecules, biomarkers, or protein biotherapeutics,
QPS’ LC-MS/MS laboratories provide a full range of
bioanalytical solutions to support drug development
from discovery through clinical development.
This white paper focuses on overcoming the challenges of participating in a pediatric trial. One of the biggest issues is that it is difficult to enroll participants in pediatric trials. Read these 5 strategies to help make it easier to enroll trial participants and complete successful trials.
In recent years, the pharmaceutical industry has witnessed increased political interest and attention due to the increased recognition of the economic importance and financial impact of healthcare as a component of national budgets. Biologic drugs (biologics) have attracted the attention of politicians since biologics have moved out of the niche pharmaceutical arena to contribute 17% of global pharmaceutical sales, representing revenues of more than $120bn in 2009. The market for biologics is growing at twice the rate of pharmaceutical drugs, placing significant cost pressures on government, employers, insurers, and patients. Government and insurers are using several strategies to contain costs but must ensure that the financial burden placed on patients does not restrict access to the health care system. Establishing a regulatory pathway for ‘follow-on’ biologics (biosimilars) was therefore felt to be necessary by many stake holders to encourage competition and reduce prices. Many pharmacutical companies both large and small - are expecting their bottom line growth to be driven by biosimilars and are channeling their R&D budgets to compete in what – according to many - is going to be one of the hottest areas in a radically changing global pharmaceutical market.
Three Lessons to Help Accelerate Pharmaceutical Breakthroughs for CNS DisordersQPS Holdings, LLC
"Developing therapies for diseases of the central nervous system (CNS) presents special challenges directly related to the complexity of the human brain and its function of integrating our communications with the outside world. Animal models of human neurological and psychiatric disorders are scarce, because many of these human diseases do not naturally occur in animals, and their study necessitates either specific manipulation (induced models) or the production of genetically modified rodents (transgenic and KO models). Even with these models, it remains unclear, what behavioral domain really resembles higher brain function in humans, and how we can interpret animal data on cognition, emotion, social interaction or activities of daily living.
Furthermore, in contrast with other organs, the CNS is sequestered from the general circulation by the blood brain barrier (BBB), potentially preventing many compounds from reaching their intended target. Quantifying how much of and how long a compound resides in the CNS is difficult and indirect. Therefore, the assessment of target engagement calls for specific techniques and know-how. While animal models provide some information as to how well a given compound accesses the brain, this data cannot always be translated directly to humans. Insufficient knowledge of target-compound interaction may be a major cause of failure in drug development for CNS disorders.
QPS understands the specific challenges of translation from animal models to human clinical application. Our extensive experience in CNS affords us a clear view of its complexities and its current global clinical study environment. Our direct links with the international scientific community and close relationships with key opinion leaders worldwide, together with our dedicated experts, original strategies and operational transparency, are keys to the effective execution of CNS programs for our clients."
The Nobel Prize for the discovery that double-stranded RNAs (dsRNAs) can trigger silencing of complementary messenger RNA sequences was awarded in 1998 and the term ‘RNA interference’ (RNAi) was born, opening the door to a completely novel and untapped market within the pharmaceutical industry. Shortly thereafter, short dsRNAs — or short interfering RNAs (siRNAs) — were generated artificially and used to demonstrate that this process also occurs in mammalian cells. The knowledge that small strands of RNAs can affect gene expression has had a tremendous impact on basic and applied research, and RNAi is currently one of the most promising new approaches for disease therapy. In 2004, only six years after the discovery of RNAi, the first siRNA-based human therapeutics — developed to treat wet age-related macular degeneration — entered phase I clinical trials. RNAi is one of the fastest advancing fields in biology, and the flow of discovery gives true meaning to the expression ‘from the bench to the bedside'.
Sometimes practical or ethical considerations dictate whether healthy volunteers or patients should be recruited for a particular study. But there are usually sound scientific arguments for collecting PK data from actual patients, to supplement or substitute for PK data obtained from human healthy volunteers during the first phases of drug development. Knowing to what extent the results obtained in healthy volunteers – if available - can be extrapolated to the intended treatment population is critical. The US FDA has recognized the importance of PK studies for determining drug concentration-time profiles in target patient populations.
This white paper focuses on the 505(b)(2) New Drug Approval (NDA) regulatory pathway, which relies on the public literature of clinical studies and/or the FDA's filing of safety and efficacy data for a previously approved drug.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
263778731218 Abortion Clinic /Pills In Harare ,ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group of receptionists, nurses, and physicians have worked together as a teamof receptionists, nurses, and physicians have worked together as a team wwww.lisywomensclinic.co.za/
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
1. QPS IS YOUR GLOBAL LINK FROM CANDIDATE SELECTION TO
PHASE II PROOF OF CONCEPT
2. QPS is a highly competent, high-quality, yet cost effective and
QPS will help you navigate effectively through the discovery processes of
accessible CRO that goes above-and-beyond to build a trusting
lead optimization and candidate selection to accelerate your compounds
relationship with you. into development!
Please allow us to help save you valuable time and decrease the cost
of drug development by linking with QPS for the following suite of A well-conceived and executed IND-enabling preclinical program and completion of early
global drug discovery and development services: clinical trials will provide you with a detailed assessment of your drug candidate including
the most cost-effective and timely pathway to filing an IND and completion of the phase
II proof-of-concept studies. Before we begin executing your IND-enabling preclinical
YOUR GLOBAL LINK TO DMPK & TOXICOLOGY SERVICES program at QPS, you will receive strategic review and advice on the design of your ADME
Preclinical Services at our USA and Taiwan Facilities and pharmacology-toxicology studies together with an in-depth analysis of deficiencies
and potential roadblocks whereby non-clinical development objectives will be confirmed.
High quality DMPK & Toxicology capabilities (full AAALAC Accreditation Furthermore timelines for your overall program and individual studies will be mapped out
since 2000) and crucial milestones established. In addition, you will receive consultation by
Supported over 1000 GLP toxicology studies since 1997 experienced clinical pharmacologists and project managers on developing the clinical
development plan beginning with the first-in-human study to completion of the phase II
proof-of-concept studies. The latter consultation will involve the identification of
YOUR GLOBAL LINK TO BIOANALYTICAL SERVICES appropriate biomarkers for early indications of biological activity by highly trained
GLP Bioanalytical Facilities in the USA, Europe, India and Taiwan translational medicine scientists as well.
One of the largest CROs in bioanalysis for small molecules and biologics During execution of your IND-enabling program you will benefit from QPS' operational
strengths, strong scientific/regulatory pre-IND/IND support and drug development
Extensive list of validated assays; > 800 and growing experience:
Chromatography & Mass Spectrometry (LC-MS/MS)
Biochemistry & Immunology (ELISA, hybridization-ELISA) OPERATIONAL STRENGTHS
Elemental Spectrometry (ICP-MS) ADME scientists and toxicologists with extensive industry and CRO experience allow
for optimal planning, and execution of ADME and pharmacology-toxicology studies
State-of-the-art ADME, toxicology, and bioanalytical facilities
YOUR GLOBAL LINK TO TRANSLATIONAL MEDICINE SERVICES
Rapid execution and completion of all non-clinical studies required for IND submis-
Specialized biomarker assay capabilities in various niche areas
sions
Assistance with selection and evaluation of the right biomarkers during
All studies will be carefully monitored and every phase of the studies critically assess
early drug development
for scientific rigor and quality by a dedicated program manager with pharma or
Molecular biology/genomic services including RNA/DNA isolation; SNP biotech background
genotyping and genetic mutation analysis; quantitative RT-PCR; RNA
Fast turnaround on high quality non-clinical study reports
expression analysis; and microarray gene expression profiling
Extensive experience in the preparation of ADME and pharmacology-toxicology
sections of IND submissions
YOUR GLOBAL LINK TO EARLY STAGE CLINICAL RESEARCH SERVICES Rapid initiation of study and enrollment of human subjects in phase I studies
Over 400 phase I beds in the USA, Europe, India, and Taiwan; one of the Seamless coordination between the clinical research unit and the bioanalytical
best and largest phase I site offerings in the world catering both to the facility to rapidly generate data from single and multiple dose escalation studies
needs of the innovative and the generic pharmaceutical industries
Data management, statistical analysis and preparation of high quality clinical study
Highly experienced, flexible and customer-focus phase I units leading to reports
better efficiency and quality during the conduct of your early stage
clinical trials
SCIENTIFIC REGULATORY PRE-IND/IND/EARLY CLINICAL RESEARCH SUPPORT
Review and gap analysis of available data, non-clinical and clinical development
YOUR GLOBAL LINK TO LATE STAGE CLINICAL RESEARCH SERVICES plans
Worldwide contract clinical staffing and pharmacometrics capabilities Advice on the design and timing of ADME, safety pharmacology, toxicology, clinical
(incl. data management, biostatistics, PK/PD evaluation and medical pharmacology and phase II proof-of-concept studies
writing capabilities) that will expedite your next development milestone
Provide expert advice on ADME and pharmacology toxicology issues associated with
ahead of schedule
a broad range of therapeutic areas
Rapid completion of the ADME and pharmacology toxicology sections of the IND to
enable client to file the IND in a timely manner
Participate in pre-IND meeting with regulatory agencies
Rapid completion of phase I and phase II proof-of-concept studies and advance drug
candidate to phase IIb
Should you want to discuss your questions in more detail with one of our experts, please
contact us directly at: info@qps.com
Corporate Office
Delaware Technology Park, 3 Innovation Way, Suite 240, Newark, DE 19711
www.qps.com
Email: ind@qps.com TEL: + 1 302 369 5601 FAX: + 1 302 369 5602
2012 QPS Holdings. All Rights Reserved