WIXLIB

PAREXEL CLINICAL RESEARCH SERVICES: EARLY PHASESTARTING STRONGERIN PHASE I THROUGH IIAAdding value from first-in-human through proof-of-concept

YOUR JOURNEY.OUR MISSION. Achieve success through early testing of compounds inpatients and healthy volunteers.As an established partner to the biopharmaceutical industry, PAREXELknows the complex challenges you face today: accessing target patientpopulations and healthy volunteers, navigating regulatory issues,and ensuring data quality. There is little—or no—room for error.We anticipate obstacles and offer timely solutions. With a full scopeof services from First-in-Human (FiH) through Proof-of-Concept (PoC),our Early Phase Services help you set a solid foundation so that youhave a better chance of achieving success. Our consistent deliveryof timely results and high-quality data adds value now—and greatervalue in the long term. We provide expertise and guidance to help youcollect the right data and mitigate the risk of Phase III failure. Extensive therapeutic expertiseENSURING SAFETY FOR YOUR FIRST-IN-HUMAN STUDIES 125 healthy volunteer studiesperformed annuallyYour journey from new molecule to new medicine starts with access 200 early phase trials in patientswithin the last 3 years 35 diverse patient populationsenrolled each yearto diverse patient populations and healthy volunteers, world-classfacilities, and more timely results. PAREXEL provides comprehensiveearly phase testing services through our own hospital-based clinicalunits on three continents. This ensures the highest patient safetystandards, on-site lab facilities, and quick, in-house access to thevolunteers you need—delivering the best return on your investment. Strategic global locations in 4unique regulatory environments Parallel drug development inmultiple clinics Global harmonization/seamlessmulti-center conduct Flexible, rapidly mobilized studyteams Development planning andregulatory support & consultingservices1

EARLY PRODUCTDEVELOPMENTEARLY PHASEPhase I HNVPhase Ib-PoC Clinical TrialsEPCU ClinicsUnique Clinical SOPsProtocol DevelopmentClinical OperationsFIM Safety SOPsProject ManagementPK/PD & PharmacometricsClinical MonitoringBiomarkersFeasibilityData SciencesLATE PHASEProtocol DevelopmentMedical AffairsSafety MonitoringStart UpData SciencesMedical WritingClinical MonitoringStart UpPhase I/II Site NetworksHELPING CLIENTS MAKECRITICAL GO/NO-GO DECISIONSINTEGRATING ALL FACETS OFTRANSLATIONAL DEVELOPMENTOur Early Product Development (EPD)team delivers exceptional Phase IIaresearch by offering the speed anddexterity translational medicine expects,while also being supported by a globalscientific, regulatory and clinicalorganization.STRATEGY & CONSULTINGeCLINICAL TECHNOLOGYCLINICAL LOGISTICSProduct Development PlanningTranslational Medical ImagingImport/Export ManagementPerceptive MyTrials Storage & DistributionIVRS/IWRSMP & NIMP SuppliesEDC – DataLabs Lab Logistics & Sample ManagementCTMS – IMPACT Data SciencesRegulatory AffairsIND/CTA FilingFDA/EMA MeetingsEnd of Phase II MeetingsClinical & Manufacturing Ramp UpCommercializationMedical WritingClinical MonitoringSolution driven capabilities: Dedicated clinical operations teams that areexperienced in all aspects of early clinical activityand site management (safety, labs, monitoring,technical training, cohort review, and recruitmentscreening) Operational flexibility that supports uniquelycustomized solutions such as multi-stage doseescalation protocols and adaptive designs Unique clinical SOPs that cover, clinical operations,project management, clinical monitoring, feasibility,start up and a Phase I/II site network Therapeutically aligned teams with expertise inoncology, CNS, immunology, respiratory/autoimmune,hepatic and renal failure, and pediatrics 90 dedicated global employees executing studies inNorth America, Europe and Asia-Pacific Integrated planning and management to takeprograms from IND through Proof-of-Conceptunder a single contract23

THE RIGHT PATIENTS FORFASTER ENROLLMENTPAREXEL’s vast database of patients and healthyvolunteers allows us to quickly recruit and enrollvolunteers to meet—and even exceed—studyenrollment timelines.Close collaboration among our early phase clinical units in United States,Europe, and South Africa facilitates expedited parallel recruitment forthose occasions when you might challenge us with an unusual patientpopulation, tougher inclusion criteria or tighter timelines. We are readyfor these challenges with global SOPs, harmonized processes, andpre-screened patient databases.49 DIFFERENTPATIENT TYPES12KEYINTHERAPEUTIC AREASRESULTING INOVER6,900 PATIENTSENROLLED290INDIFFERENTPATIENT STUDIESIN JUST THEYEARS ALONE!LAST54WORLD LEADER OF ETHNOBRIDGING TRIALSInclusion of Asian countries in global drug developmentand registration of drugs in the Asia Pacific regionhas become increasingly important in recent years.Global companies are collecting Japanese, Chinese andKorean Phase I data early in development to fulfill thefollowing goals: Fast track Japan development—Chinese andKorean PK data are frequently neededOver the years, scientists at PAREXEL have workedclosely with Asian regulators to design studies doneoutside of Asia but accepted by the Asian regulators.In fact, we have developed the definition of a Japanesesubject, which is now widely used in the industry.Our experts are available to provide consultationand input to regulatory issues, protocol designs andanalysis of data. Facilitate Asian trials Facilitate the inclusion of Asian countries inglobal trials Use data for drug registration in the regionOver the past 12 years, we have successfully conductedover 120 ethnobridging studies, enrolling more than 3,000subjects. Our unit in Los Angeles is the home to thelargest first generation Asian community anywhere in theworld. No other city, including Honolulu, comes close.5

INTEGRATEDEXPERTISEFOR A MORESUCCESSFULOUTCOMEWith in-depth scientific and therapeuticexpertise, we design and implementearly phase studies for new drug entitiesacross a broad range of therapeuticindications. Our team provides customized solutions, including the appropriateuse of biomarkers and adaptive trialdesigns.67

UNPARALLELED EXPERIENCEACROSS A SPECTRUM OFTHERAPEUTIC SPECIALTIESONCOLOGY/HEMATOLOGYCARDIOVASCULARThe emergence of targeted oncology and hematologytherapies for cancer and blood disorders has createdtremendous hope for the millions of patients whosuffer from these diseases. Our team of oncologistsand hematologists have participated in trials for manydifferent classes of cancer therapeutics, includingextensive work in cytotoxics, biologics, targetedtherapeutics, immunotherapies, vaccine therapies,and supportive-care products.Cardiac safety is a critical factor in clinical trials. Ourcomprehensive cardiovascular expertise comes witha wide range of related services such as Intensive ECGand Thorough QT/QTc studies to assess cardiac safetyof new compounds. Each of our units has a considerablenumber of beds equipped with telemetric bedsidemonitoring and ambulatory/holter ECG equipment. Aseasoned staff provides top-quality readings of clinicalcardiovascular data. Additionally, we collaborate withmost ECG core labs and can easily work with yourpreferred lab. All clinical units have state-of-the-artequipment and perform cardiac studies according tointernational guidelines.CNSPAREXEL’s Early Phase clinical experts are equippedwith the knowledge to deliver a wide range of servicesand techniques in psychiatric and neurological studiesof varying complexity, with emphasis in acute psychiatricand sleep disorders. Our experience conducting studiesin Parkinson’s and Alzheimer’s disease, schizophrenia,and major depressive disorders, among others, issecond to none.8RESPIRATORYWe have considerable experience in performing Phase Ithrough Phase IIa clinical trials in respiratory medicineand therapeutics. Our sites are equipped with the latestin sophisticated respiratory monitoring technologies,including whole-body plethysmography and spirometry.We routinely perform exercise testing, bronchialchallenges, and additionally, through our hospital-basedunits, can access more complex measurements suchas bronchoscopy and bronchoalveolar lavage (BAL).Our access to respiratory populations is unrivaled andPAREXEL provides the ultimate benefit for your trialinrespiratory patients—the season switch. Our locationsin both northern and southern hemispheres allowan uninterrupted flow of patients without seasonaldisruption.METABOLISM/ENDOCRINEPAREXEL offers manual glucose clamp studies in acutting-edge, 10-bed glucose clamp unit. More than 40studies have been performed in both healthy volunteersand patients with Type I and Type II diabetes since theclamp unit opened in 1995. We are constantly recruitingto expand our extensive database of Type I and Type IIdiabetes patients. We also have considerable experiencein obesity studies.Other areas of therapeutic expertise include infectiousdisease, allergy/immunology, dermatology, rheumatology and pain.9

FULL SCOPE OFSERVICES TOHANDLE THE MOSTCOMPLEX STUDIESThe breadth of our capabilitiesand harmonization acrossour global clinical units enablePAREXEL to carry outextremely complex studies.OVER 30 YEARS’EXPERIENCEEARLY PHASE SERVICES INCLUDE: First-in-Human Proof-of-ConceptKEY INDUSTRYOPINION LEADERS Ethnobridging Dose escalation (including long-stay studies) Clinical pharmacology Pharmacokinetic/pharmacodynamiccharacterizations Disease modeling Polysomnography tQTcHIGH QUALITYPROJECTMANAGEMENT Bioequivalence/bioavailability Bioanalytical and biomarker services Biomarker development and analysis Clinical data services Positron-Emitting Tomography (PET) Functional Magnetic Resonance Imaging (fMRI) Quantitative EEGTECHNOLOGYDRIVEN Evoked potential techniques Inpatient acute psychiatric therapies1011