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Pharma Services Category of PAREXEL International Corporation

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BioAnalytical Services

Clinical Development / Phase IIb-IV

Compliance, Regulatory & Consulting

Core / Central Lab

Early Clinical / Phase I-IIa

Medical Writing & Language Translation

Packaging & Logistics

Patient / Investigator Recruitment

Post Marketing

Technology / Data / Analytics

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PAREXEL International Corporation

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UNITED STATES

Regulatory Outsourcing Services

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

Late Phase Partnerships

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Epidemiology

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Bioanalytical & Biomarkers

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- Service Details

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

- Directory Listing

Pharma Service: Analytical

Category: BioAnalytical Services

Sub Category: Bioanalytical & Biomarker Testing Services

Medical Imaging

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

Clinical Trial Patient Recruitment

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Patient / Investigator Recruitment

Sub Category: Patient Recruitment

Simplify Study Design

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- Service Details

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™

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Clinical Trial Design

Breaking the Data Barrier

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Data Management

Clinical Trial Supplies & Logistics

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Packaging & Logistics

Sub Category: Clinical Trial Supplies

Cold Chain Logistics

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- Service Details

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).

- Directory Listing

Pharma Service: Clinical Trials

Category: Packaging & Logistics

Sub Category: Cold Chain Solutions

Clinical PK/PD and Pharmacometrics Services

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- Service Details

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.

Bioequivalence Studies

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Early Clinical / Phase I-IIa

Sub Category: Phase I / IIa

Drug Safety Services

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Electronic Clinical Outcome Assessments (eCOA...

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Trial Monitoring

Phase 1 Clinical Trials

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Early Clinical / Phase I-IIa

Sub Category: Phase I / IIa

Phase lla

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Early Clinical / Phase I-IIa

Sub Category: Phase I / IIa

Phase ll-lll

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase II / III

Phase lllb-lV

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

Electronic Data Capture

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Data Management

Medical Writing & Submission

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- Service Details

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.

Parexel's Education Services

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Training

Data Analytics

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

Your Strategic Guide in Product Development

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

Pharmaceutical Risk Management

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Pharma Services Category of PAREXEL International Corporation

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