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QPS Early Stage Clinical Services

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EARLY STAGE CLINICAL DEVELOPMENT …

EARLY STAGE CLINICAL DEVELOPMENT

Initiating the study of a compound's effects in humans is the first step in generating the required data for a New Drug Application (NDA).

QPS provides fully integrated phase 1 services starting from protocol development, patient stratification/genotyping, clinical conduct, bioanalysis, data management/statistical analysis, PK/PD modeling and medical report writing.

Today, we offer clients access to six highly experienced Phase I sites around the globe, all having extensive databases of (patient) volunteers in rich recruiting environments and employing highly-skilled and experienced staff using disciplined processes to give you the highest accuracy and data integrity. QPS can conduct the following clinical studies to support an application for marketing approval:
- First-in-Man: single and multiple-dose safety, tolerability and pharmacokinetic
- Drug/drug interaction \
- Bioequivalence/bioavailability
- Food effect
- Pharmacokinetics/pharmacodynamics (RAC)
- Formulation assessment
- Special population
- Gender
- Safety pharmacology (QTc interval, GI motility, etc.)
- Mechanistic
- Enzyme inhibition/induction
- CYP profiling
- Human Mass Balance
- Microdosing
- Vaccine
- Imaging (PET, fMRI)

For more information, please visit our website: www.qps.com or contact us by e-mail: info@qps.com.

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  • 1. D RUG INT E RA C TI O N SAD B i oe q u i v a l e n ce MA D Early Stage Clinical Overview H u m a n M a ss B a l a n ce Bioavailability I m a g i n g ( P E T , f MRI ) FIR S T - IN - H UMAN QPS Early Stage Clinical Overview With six Phase I sites on three continents, QPS offers comprehensive services from smallscale, complex and high-capacity studies in healthy volunteers, to Proof of Concept (POC) studies in patient or specialty populations for a wide variety of therapeutic indications.
  • 2. Introduction to QPS’ Early Stage Clinical Research Services: QPS’ six highly experienced Phase I sites are well established around the globe. As a leader in early stage clinical research services, our Clinical Pharmacology Teams routinely conduct hundreds of Phase I/IIa studies annually. QPS is one of the world’s largest Phase I contract research organizations with more than 500 Phase I beds on three continents. PK/PD Analysis Biomarkers B i os t a t i s t i cs Med i c a l W r i t i n g P r o j ec t M a n a g e m e n t Bioanalysis Data Management
  • 3. Why should QPS be your first and only choice to conduct your Phase I studies? Professional and Experienced Staff You get immediate access to our Clinical Pharmacology Teams, including internationally established clinical pharmacologists that have scientific expertise in the design of all types of Phase I studies, as well as the interpretation of the study data. Each Phase I study will have a client dedicated team, headed by an experienced C R O GLOBAL Clinical Project Manager, who has the overall responsibility for the conduct of your study and is your single point of contact throughout your Phase I study. As a full service unit, QPS can assist you with the entire early stage drug development process: PRECLINICAL Find out how to achieve your next development milestone ahead of time. Call to schedule your tour at one of QPS’ worldwide locations today! Review of Preclinical Data B OANALYTICAL StudyI Design and Protocol Writing Clinical Conduct Bioanalysis/Biomarker Assays CLINICAL DRUG DEVELOPMENT Data Management PK/PD Analysis Biostatistics Provision of CDISC-compliant Clinical Study Reports Global Flexibility and Capacity At QPS, we realize that you face many challenges in strict timelines, patient enrollment, demanding clinical data collection and reporting requirements, and budgetary constraints. TRANSLATIONAL MEDICINE QUAL With our six state-of-the-art and strategically located global Phase I facilities, we are in an excellent position to meet these needs. QPS provides high quality data, client-specified timelines and competitive pricing. Our sites also have access to large numbers of (patient) volunteers for all types of clinical studies. BIOTECHNOLOGY Customer Focus QPS focuses on meeting the needs of each client. We make certain all studies are recruited full and completed on time. We also ensure optimal communications so you have always complete visibility into your project’s status and can rest assured that your deadlines will be met and your budgets will not be exceeded. At QPS, we measure our success by your success.
  • 4. V a cc i n e S t u d i es M i c r odos i n g S t u d i es P e r so n a l i z ed Med i c i n e P r oo f o f C o n cep t S t u d i es Benefit Patients Biomarkers Specialty/Patient Studies QPS sites work either independently or together with local university and general hospitals to complete Proof of Concept (POC) studies in patient or specialty populations for a wide variety of therapeutic indications. We also develop pharmacodynamic endpoints and laboratory biomarker assays that are critical for the evaluation of your early stage compounds. Preferred Provider Relationship: Improved Efficiency and Lower Costs QPS’ Phase I sites have unique and complimentary core capabilities with expertise that remains focused in order to gain maximal efficiency. This translates to improved quality and time management which in turn translates to enhanced cost effectiveness. QPS will enter into vendor-preferred or volume discounts for the life of your drug candidate - from drug discovery through late phase. We implement maximum benefit by leveraging the distinct features of our global Phase I sites to keep your overall early stage clinical development costs as low as possible. The QPS Clinical Pharmacology Teams in the Netherlands, Taiwan, India and USA will work to ensure your study is completed to global standards and procedures. All QPS sites are connected through a global data network to simplify study management for sponsors, providing integrated information and perspective during the entire course of the drug development process. QPS offers a full range of Phase I services including but not limited to: First-in-Man Programs (SAD + MAD + FE + CYP450 Interaction) Clinical PK/PD studies Bioavailability studies Bioequivalence studies Drug Interaction studies Human Mass Balance studies Microdosing studies Imaging (PET, fMRI) studies Vaccine studies Thorough QT/QTc studies Proof of Concept (PoC) in small, well-defined patient populations across multiple disease indications (Alzheimer’s; Parkinson’s; Huntington’s; Depression; ALS; ADHD; T2DM; Asthma; COPD; RA; Psoriasis; HIV, HCV, HBV and more) Specialty Populations (Elderly; Pediatric; Hepatic Insufficiency; Renal Insufficiency; Postmenopausal; Obesity and more)
  • 5. Hyderabad, INDIA Springfield, MO, USA 92 Phase I beds 240 Phase I beds Miami, FL, USA Groningen, THE NETHERLANDS 50 Phase I beds 58 Phase I beds Taipei, TAIWAN 40 Phase I beds Hollywood, FL, USA 20 Phase I beds QPS|Missouri QPS|Florida QPS|Florida QPS|Netherlands QPS|India QPS|Taiwan
  • 6. Time is of the essence in drug development, so contact a member Company Values: Integrity - We make and keep promises and build trust through honesty, proactive communication and reliability - Quality - We bring the highest level of technical expertise and judgement to our work - Customer Focus - We tap our global resources to provide service that is fast, flexible and integrated - Commitment - We work hard to solve problems and deliver results - People - We treat people with dignity, respect and fairness, and embrace our differences - Culture - We are friendly and fun. We provide opportunities to grow, we value loyalty and teamwork, and we recognize and reward performance. of the QPS Business Development Team today and find out what QPS can do for you. GLOBAL BD Office info@qps.com www.qps.com