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    Pharma Services Category of PPD

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    HTL Biotechnology is the world leader in the responsible development and production of pharmaceutical-grade biopolymers.
    Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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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 (2)

    06 Packaging & Logistics (1)

    07 Post Marketing (3)

    08 Technology / Data / Analytics (4)

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    01 PPD (18)

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    01 U.S.A (18)

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    PPD

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    GLOBAL REGULATORY AFFAIRS SERVICES

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    PPD provides effective global regulatory affairs services for all stages of pharmaceutical, biologic and medical device product development and lifecycle management.

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    Pharma Service: Clinical Trials

    Category: Compliance, Regulatory & Consulting

    Sub Category: Regulatory Affairs
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    GLOBAL POST-APPROVAL SERVICES

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    Our clinical experience in product development ensures collaboration and integration from pre-approval to post-approval. We provide a custom-tailored process, fine-tuned across the globe, to meet local regulatory requirements.

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    Pharma Service: Clinical Trials

    Category: Post Marketing

    Sub Category: Pharmacovigilance / Product Lifecycle Management
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    BIOANALYTICAL CONTRACT LABORATORY SERVICES

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    PPD is a bioanalytical contract laboratory focused on delivering life-changing therapies. It offers bioanalytical contract solutions & laboratory services including bioanalytical testing & biomarkers analysis for biologics, proteins, biosimilars, etc.

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    Pharma Service: Analytical

    Category: BioAnalytical Services

    Sub Category: Bioanalytical & Biomarker Testing Services
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    EARLY DEVELOPMENT CLINICAL RESEARCH SERVICES

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    Program services offered by both clinics range from medical writing, clinical conduct and data management to monitoring, biostatistics and clinical pharmacology.

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    Pharma Service: Clinical Trials

    Category: Early Clinical / Phase I-IIa

    Sub Category: Phase I / IIa
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    CLINICAL & MEDICAL IMAGING

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    PPD partnered with VirtualScopics to provide an integrated and seamless clinical and medical imaging offering that spans multiple therapeutic areas and allows clients to realize time and cost efficiencies across all trials.

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    Pharma Service: Clinical Trials

    Category: Core / Central Lab

    Sub Category: Clinical & Medical Imaging
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    CLINICAL TRIAL MONITORING

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    Our skilled and well-trained clinical research associates (CRAs) ensure the highest quality review of data and effective interaction with study sites. Our CRAs conduct on-site monitoring visits throughout the study.

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    Pharma Service: Clinical Trials

    Category: Technology / Data / Analytics

    Sub Category: Clinical Trial Monitoring
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    GLOBAL CLINICAL SUPPLY CHAIN SERVICES

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    With extensively trained local resources in North America; Europe, the Middle East, Africa (EMEA); and Asia Pacific, PPD offers a full range of services to manage the clinical supply life cycle. These services are integrated in PPD’s clinical services and accomplished through extensive communication

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    Pharma Service: Clinical Trials

    Category: Packaging & Logistics

    Sub Category: Clinical Trial Supplies
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    CLINICAL BIOSTATISTICS SERVICES

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    PPD’s global clinical biostatistics and programming team offers more than statistical analyses. We bring a deep understanding of the science of disease and compounds, as well as provide valuable upfront study design and comprehensive planning assistance.

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    Pharma Service: Clinical Trials

    Category: Technology / Data / Analytics

    Sub Category: Clinical Biostatistics and Programming
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    ELECTRONIC DATA CAPTURE (EDC)

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    PPD has significant experience in database building, clinical monitoring and data management activities using multiple EDC systems, including Medidata Rave, Oracle® Clinical Remote Data Capture, InForm and OmniComm®.

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    Pharma Service: Clinical Trials

    Category: Technology / Data / Analytics

    Sub Category: Data Management
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    PHARMACOVIGILANCE SERVICES

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    Our experienced team of more than 700 pharmacovigilance professionals worldwide provide 24/7/365 availability and is fully focused on identifying and applying valuable insights based on pharmacovigilance needs.

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    Pharma Service: Clinical Trials

    Category: Post Marketing

    Sub Category: Pharmacovigilance / Product Lifecycle Management
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    CLINICAL QUALITY & COMPLIANCE SERVICES

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    PPD's clinical quality assurance (CQA) services help our clients ensure the integrity of their clinical trials. We advise clients on how to verify the integrity of scientific data and ensure adherence to protocols and international regulatory guidelines. We also help clients protect research

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    Pharma Service: Clinical Trials

    Category: Compliance, Regulatory & Consulting

    Sub Category: Quality & Compliance
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    PPD CONSULTING SERVICES

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    With more than 25 years of experience, PPD brings diverse expertise across therapeutic areas and functional disciplines to provide biopharmaceutical consulting services throughout the product life cycle.

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    Pharma Service: Clinical Trials

    Category: Compliance, Regulatory & Consulting

    Sub Category: Consulting Services
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    CLINICAL DATA MANAGEMENT SERVICES

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    PPD’s clients can employ the technology, processes and expertise that best meet the needs of their project with PPD’s clinical data management solutions. Across a broad range of therapeutic areas and quantitative methods, PPD has extensive data management experience for Phase I-IV clinical

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    Pharma Service: Clinical Trials

    Category: Technology / Data / Analytics

    Sub Category: Data Management
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    RISK MANAGEMENT & REMS STRATEGIES

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    Our risk management team works in a matrix approach with departments across PPD. Experts in epidemiology, registries and observational studies, regulatory affairs, pharmacovigilance and call center operations provide support to REMS programs.

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    Pharma Service: Clinical Trials

    Category: Post Marketing

    Sub Category: Pharmacovigilance / Product Lifecycle Management
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    PHASE I CLINIC CAPABILITIES

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    PPD’s Phase I clinic conducts approximately 100 studies per year and has sufficient capacity to carry out multiple studies of varying design simultaneously. Research-experienced, board-certified physicians serve as principal investigators for Phase I studies. Secure and confidential drug

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    Pharma Service: Clinical Trials

    Category: Early Clinical / Phase I-IIa

    Sub Category: Phase I / IIa
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    CLINICAL DEVELOPMENT SERVICES

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    Our experience, support systems and infrastructure enable us to provide the highest level of program management and clinical development services for Phase II-IIIb clinical trials.

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    Pharma Service: Clinical Trials

    Category: Clinical Development / Phase IIb-IV

    Sub Category: Phase II / III
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    PHASE IV MONITORED TRIALS

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    Phase IV monitored trials collect data to address issues that support product success in a real-world clinical practice. With our extensive Phase IIIb-IV experience, PPD designs and executes Phase IV monitored trials.

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    Pharma Service: Clinical Trials

    Category: Clinical Development / Phase IIb-IV

    Sub Category: Phase IV
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    MEDICAL DEVICE DEVELOPMENT INDUSTRY EXPERTISE

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    Clients can accelerate the process of bringing their new products to market with the experience, resources and global reach of PPD’s medical device development team.

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    Pharma Service: Clinical Trials

    Category: Compliance, Regulatory & Consulting

    Sub Category: Medical Devices
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