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    Pharma Services Category of PAREXEL International Corporation

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    01 BioAnalytical Services (1)

    02 Clinical Development / Phase IIb-IV (2)

    03 Compliance, Regulatory & Consulting (4)

    04 Core / Central Lab (1)

    05 Early Clinical / Phase I-IIa (4)

    06 Medical Writing & Language Translation (1)

    07 Packaging & Logistics (2)

    08 Patient / Investigator Recruitment (1)

    09 Post Marketing (4)

    10 Technology / Data / Analytics (4)

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    01 PAREXEL International Corporation (24)

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    PAREXEL International Corporation

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    REGULATORY OUTSOURCING SERVICES

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    Our Regulatory Outsourcing Services include both pre-approval and post-approval activities ranging from the compilation, publishing, and dispatching of large regulatory dossiers to the authoring of routine product variations, annual reports and other product lifecycle maintenance tasks.

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    Pharma Service: Clinical Trials

    Category: Compliance, Regulatory & Consulting

    Sub Category: Regulatory Affairs
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    LATE PHASE PARTNERSHIPS

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    PAREXEL's Peri/Post-Approval Services group of experts are dedicated to late phase research, offering a proven partnership model designed specifically for Late Phase.

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    Pharma Service: Clinical Trials

    Category: Post Marketing

    Sub Category: Pharmacovigilance / Product Lifecycle Management
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    EPIDEMIOLOGY

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    At PAREXEL® we have senior Epidemiologists, and Statisticians, who have many years experience within the pharmaceutical industry providing solutions to the questions faced by our clients.

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    Pharma Service: Clinical Trials

    Category: Post Marketing

    Sub Category: Pharmacovigilance / Product Lifecycle Management
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    BIOANALYTICAL & BIOMARKERS

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    PAREXEL® Early Phase offers the highest quality bioanalytical services for qualitative and quantitative drug, metabolite, and biomarker analysis in a variety of matrices.

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    Pharma Service: Analytical

    Category: BioAnalytical Services

    Sub Category: Bioanalytical & Biomarker Testing Services
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    MEDICAL IMAGING

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    PAREXEL Informatics is a global leader in helping pharmaceutical and biotech companies employ time- and budget-saving medical imaging in clinical trials.

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    Pharma Service: Clinical Trials

    Category: Core / Central Lab

    Sub Category: Clinical & Medical Imaging
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    CLINICAL TRIAL PATIENT RECRUITMENT

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    PAREXEL leverages over 30 years of clinical trials experience with a data-driven approach that integrates all drivers of effective clinical trial patient recruitment.

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    Pharma Service: Clinical Trials

    Category: Patient / Investigator Recruitment

    Sub Category: Patient Recruitment
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    SIMPLIFY STUDY DESIGN

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    During study design, it’s critical to to optimize protocol design and global placement to achieve predictable delivery and avoid amendments that slow the process. After all, 55% of trial delays happen at the site level[1], which can have a cascade effect downstream. PAREXEL's ForeSite™

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    Pharma Service: Clinical Trials

    Category: Compliance, Regulatory & Consulting

    Sub Category: Clinical Trial Design
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    BREAKING THE DATA BARRIER

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    At PAREXEL®, we believe the world would be a better place if life-changing therapies could get to market more easily. But meeting the challenges of today’s drug development environment takes advanced, integrated technology and expert services that help break the barriers created by clinical

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    Pharma Service: Clinical Trials

    Category: Technology / Data / Analytics

    Sub Category: Data Management
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    CLINICAL TRIAL SUPPLIES & LOGISTICS

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    Parexel's dedicated Clinical Trial Supplies & Logistics team uses industry-leading supply chain intelligence developed through the combined expertise of PAREXEL specialists and its eClinical and eLogistics teams.

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    Pharma Service: Clinical Trials

    Category: Packaging & Logistics

    Sub Category: Clinical Trial Supplies
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    COLD CHAIN LOGISTICS

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    PAREXEL’s global supply chain network of coordination hubs, distribution centers and depots have storage, packaging and distribution facilities for various temperatures e.g.n-20°C, 2-8°C, 15-25°C, -70°C (on request).

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    Pharma Service: Clinical Trials

    Category: Packaging & Logistics

    Sub Category: Cold Chain Solutions
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    CLINICAL PK/PD AND PHARMACOMETRICS SERVICES

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    PAREXEL’s global team of experienced clinical pharmacokineticists and pharmacometricians offer unsurpassed expertise in Clinical PK/PD and Pharmacometrics, from pre-clinical to Phase III studies.

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    Pharma Service: Clinical Trials

    Category: Early Clinical / Phase I-IIa

    Sub Category: Pharmacokinetics / Pharmacodynamics / Pharmacometrics
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    BIOEQUIVALENCE STUDIES

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    With more than 40 years of experience in performing bioequivalence studies, our clinical unit in Bloemfontein, South Africa, is a center of excellence. It is strategically placed in the perfect location for these trials a lower cost and fast start-up environment.

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    Pharma Service: Clinical Trials

    Category: Early Clinical / Phase I-IIa

    Sub Category: Phase I / IIa
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    DRUG SAFETY SERVICES

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    PAREXEL understands that patient safety is at the heart of every company’s focus. This is why we are committed to delivering quality, integrated drug safety services across the full spectrum of the post-approval life cycle.

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    Pharma Service: Clinical Trials

    Category: Post Marketing

    Sub Category: Pharmacovigilance / Product Lifecycle Management
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    ELECTRONIC CLINICAL OUTCOME ASSESSMENTS (ECOAS)

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    PAREXEL® has the expertise and services to optimize design and implementation of studies that utilize COA data collection, delivering both scientific and operational capabilities.

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    Pharma Service: Clinical Trials

    Category: Technology / Data / Analytics

    Sub Category: Clinical Trial Monitoring
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    PHASE 1 CLINICAL TRIALS

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    PAREXEL® has the global SOPs to perform Phase 1 clinical trials in harmony across multiple locations, and stands committed to the success of your journey.

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    Pharma Service: Clinical Trials

    Category: Early Clinical / Phase I-IIa

    Sub Category: Phase I / IIa
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    PHASE LLA

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    PAREXEL® has developed an integrated and adaptive approach that supports Phase IIa outcomes.

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    Pharma Service: Clinical Trials

    Category: Early Clinical / Phase I-IIa

    Sub Category: Phase I / IIa
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    PHASE LL-LLL

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    Your progress to Phases IIb and III will have twists and turns. PAREXEL’s worldwide infrastructure and end-to-end expertise can help you optimize your studies and implement pivotal trials expeditiously.

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    Pharma Service: Clinical Trials

    Category: Clinical Development / Phase IIb-IV

    Sub Category: Phase II / III
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    PHASE LLLB-LV

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    PAREXEL® has provided world class Late Phase services for over a decade. This is why we know this part of your journey so well. We helped plan it.

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    Pharma Service: Clinical Trials

    Category: Clinical Development / Phase IIb-IV

    Sub Category: Phase IV
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    ELECTRONIC DATA CAPTURE

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    The DataLabs® EDC (Electronic Data Capture) solution is uniquely focused on simplifying workflows and delivering superior user experiences. Its advanced EDC features help streamline the entire process starting from study design all the way to collection, management and reporting of clinical

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    Pharma Service: Clinical Trials

    Category: Technology / Data / Analytics

    Sub Category: Data Management
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    MEDICAL WRITING & SUBMISSION

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    The Medical Writing Services group at PAREXEL is uniquely qualified to help you compile, organize, write, edit, and produce a wide range of medical and scientific documentation required to support your product development efforts.

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    Pharma Service: Clinical Trials

    Category: Medical Writing & Language Translation

    Sub Category: Clinical Research Translation / Validation
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    PAREXEL'S EDUCATION SERVICES

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    PAREXEL's Education Services offers flexible, customizable and end-to-end technology training and training compliance solutions to increase clinical trial and regulatory performance.

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    Pharma Service: Clinical Trials

    Category: Compliance, Regulatory & Consulting

    Sub Category: Training
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    DATA ANALYTICS

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    Assisting biopharmaceutical companies position the comparative value of products, therapies, and portfolios, we provide a full continuum of data analytic services from tabular reports to multivariate statistical modeling, all in support of your commercial decision making.

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    Pharma Service: Clinical Trials

    Category: Technology / Data / Analytics

    Sub Category: Clinical Biostatistics and Programming
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    YOUR STRATEGIC GUIDE IN PRODUCT DEVELOPMENT

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    PAREXEL Consulting overcomes the obstacles to get products to market faster and smarter. Our scientific, regulatory, and operational expertise puts best practice standards to work for clients large and small, designing solutions for a constantly evolving healthcare landscape.

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    Pharma Service: Clinical Trials

    Category: Compliance, Regulatory & Consulting

    Sub Category: Consulting Services
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    PHARMACEUTICAL RISK MANAGEMENT

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    PAREXEL's Pharmacovigilance services includes a wealth of experts in the field of Risk Management planning and strategy, many with FDA and MHRA backgrounds.

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    Pharma Service: Clinical Trials

    Category: Post Marketing

    Sub Category: Pharmacovigilance / Product Lifecycle Management
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