Metabolic Solutions

PPD Solutions

Flexible and Customized Solutions to Address Your Unique Needs

We take a medically and scientifically informed, proactive approach to trial design, helping clients plan for specific scientific issues that may impact the efficacy and/or safety aspects of a product, including:

  • Insulin or glucose clamp paradigms
  • Biomarkers of inflammation and immunomodulation
  • Efficient designs for evaluating treatment combinations
  • Regulatory requisite studies by product class
  • Adverse events of special interest by product class
  • Hyperglycemia rescue
  • Mixed meal tolerance tests
  • Oral glucose tolerance tests
  • Cardiovascular safety
  • Lipids profiles including more atherogenic lipoprotein subfractions

PPD also guides clients through the critical — and often uniquely challenging — process of recruiting for diabetes trials. We help identify, enroll and retain the desired study population to ensure study objectives are accurately and effectively met.

PPD has the solutions

An Innovative Approach to Addressing Major Cardiovascular Events

Having executed more than 30 global trials with adjudicated clinical endpoints, PPD implements a systematic approach to the surveillance and adjudication processing for major cardiovascular events (MACE). Our centralized team of adjudication experts developed an electronic system that encompasses all stages of adjudication, including event identification, dossier compilation, committee submission, arbitrations and final classification of events. This system provides the following advantages:

  • A global, 21 Code of Federal Regulations (CFR) Part 11 compliant, Web-based system
  • Access for reviewing events and documentation from multiple data sources
  • An online interface for the endpoint adjudication committee to confirm adjudicated events or request follow-up information
  • Daily review of all new and changed adverse events
  • Immediate tabulation of adjudicated outcomes
  • Tracking of aging of in-process events and individual committee members’ workload

Additionally, PPD uses standard medical dictionary for regulatory activities (MedDRA) queries specific for MACE to ensure no potential cardiovascular event is missed.

PPD Global Network

A Global Network of Talent with Deep and Broad Expertise

With PPD, clients have access to more than 1,600 endocrine/metabolic professionals and staff. They can also tap into the knowledge and expertise of our global network of 1,500+ endocrinologists and 22,600 physicians.

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PPD Solutions

Flexible and Customized Solutions to Address Your Unique Needs

At PPD, we’re committed to developing flexible and customizable solutions that fit the specific needs of clients of any size for any study in any region. We help clients prepare for success by providing strategic clinical study design planning, ranging from smaller consulting contracts to full programs.

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PPD Technology

PPD® Laboratories: Support for Endocrine/Metabolic Trials and Beyond

To ensure precision and consistency of data across multiple sites, PPD Laboratories offers comprehensive services to meet all of our clients’ laboratory needs in one place.

What PPD Laboratories Include »
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