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Pharma Services Category of Pharmaceutical Product Development, LLC

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BioAnalytical Services

Clinical Development / Phase IIb-IV

Compliance, Regulatory & Consulting

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Early Clinical / Phase I-IIa

Packaging & Logistics

Post Marketing

Technology / Data / Analytics

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Pharmaceutical Product Development, LLC

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UNITED STATES

Global Regulatory Affairs Services

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

Global Post-Approval Services

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Bioanalytical Laboratory Services

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- Service Details

For more than 30 years, PPD® Laboratories’ bioanalytical lab has been dedicated to helping clients advance their research programs by providing high quality, accurate results across all phases of pharmaceutical development and commercialization.

- Directory Listing

Pharma Service: Analytical

Category: BioAnalytical Services

Sub Category: Bioanalytical & Biomarker Testing Services

Early Development Clinical Research Services

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Early Clinical / Phase I-IIa

Sub Category: Phase I / IIa

Clinical & Medical Imaging

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

Clinical Trial Monitoring

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Trial Monitoring

Global Clinical Supply Services

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Packaging & Logistics

Sub Category: Clinical Trial Supplies

Clinical Biostatistics Services

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

Electronic Data Capture (EDC)

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- Service Details

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®.

- Directory Listing

Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Data Management

Pharmacovigilance Services

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Clinical Quality & Compliance Services

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Quality & Compliance

PPD Consulting Services

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

Clinical Data Management Services

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Data Management

Risk Management & REMS Strategies

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Phase I Clinic Capabilities

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Early Clinical / Phase I-IIa

Sub Category: Phase I / IIa

Clinical Development Services

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase II / III

Phase IV Monitored Trials

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

Medical Device Development Industry Expertise

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Medical Devices

Pharma Services Category of Pharmaceutical Product Development, LLC

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