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Early Development

Full Suite of Comprehensive Services

Flexible solutions, from discovery through Phase IIa, customized to fit your needs.

PPD’s early development and clinical pharmacology solutions allow clients to maximize value in their early stage portfolios by developing an integrated program supported by a global team of experts. We leverage our facilities, operational experts and development experience to successfully execute programs in healthy volunteers and patients, and offer services to support later phase programs and regulatory submissions.

State-of-the-Art Clinical Pharmacology Units (CPUs)

We provide a broad range of early phase offerings in the two PPD-owned clinical pharmacology units (CPUs) located in Austin, Texas, and Las Vegas, Nevada. These state-of-the-art clinics are managed by our experienced leaders and investigators who support a range of studies in both healthy volunteers and patient populations.

In our CPUs in the past five years, we have conducted more than 840 early development studies involving more than 20,000 patients.

Early Development CRO Services

We offer a range of early development contract research organization (CRO) services executed by professionals fully dedicated to early development:

  • Project management
  • Data management
  • Biostatistics
  • Programming
  • Pharmacokinetics
  • Monitoring
  • Site feasibility
  • Site management
  • Medical writing

Clients have access to these early development CRO services as a part of an integrated program in a PPD clinical pharmacology unit, along with a client site or network site, or for stand-alone functional support.

Learn more about our early development CRO services

Strategic Site Network and Patient Recruitment

PPD’s two CPUs are supplemented by a global network of 10 U.S. and eight global clinical pharmacology sites that conduct studies in patients and specialty populations. In the past five years, our early phase network sites have participated in more than 60 studies.

Our recruitment and screening solutions allow us to rapidly enroll both healthy and patient volunteers into early phase studies. These include:

  • Comprehensive database of more than 230,000 healthy volunteers, including post-menopausal women, elderly and obese populations
  • CPUs located in large metropolitan areas near major universities
  • 50 percent repeat volunteer base
  • Text outreach utilized for recruiting and scheduling reminders
  • Real-time advertising to recruit healthy volunteers and chronic ambulatory patients, including those with diabetes and nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH)
  • Acurian, the industry-leading patient recruitment organization

Early Development Consulting

A range of early development consulting services valuable to clients for asset planning in the earliest phases of development include:

  • Clinical development planning and protocol design
  • Regulatory strategy and regulatory document preparation and submission
  • Pharmacology and toxicology strategy
  • Chemistry, manufacturing and controls (CMC) strategy and project management

Learn more about our pharmacology and CMC capabilities

PPD® Laboratories and Early Development

PPD® Laboratories provides world-class scientific expertise with state-of-the-art technologies offering early development clients comprehensive lab services spanning central lab testing, bioanalytical, biomarkers and GMP. Our laboratory services accelerate pharmaceutical discovery and development for small molecules and biologics, which allows for clients to make faster decisions about their compounds.

Learn more about PPD Laboratories

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