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Therapeutic Area Consulting

For more than 25 years, PPD has been your partner in the development of important and often life-saving therapeutics. Our product development consulting team brings the expertise and experience you need to continue to successfully deliver these therapies to the market:

  • Therapeutic area expertise in a wide variety of diseases and indications including hematology/oncology, cardiovascular disease and critical care, neuroscience, infectious diseases, metabolic disease, rheumatology, ophthalmology, respiratory and general medicine, including extensive expertise in the development of pharmaceutical products in rare diseases and pediatric indications
  • Experience in the development and approval of medical devices and companion diagnostics
  • Full range of biostatistical consulting to support first-in-human through post-approval studies
  • Effective team leadership that synchronizes cross-functional services, global development expertise and insight from therapeutic thought leaders and physicians to create customized integrated development strategies

An Integrated Approach to Therapeutic Area Consulting

With a long and successful history of consulting, our experts have broad therapeutic knowledge and an in-depth understanding of both current standards of clinical practice and state-of-the-art approaches to clinical development planning. Our expertise includes:

  • Development of cross-functional integrated product development plans
  • Development of minimum and target product profiles and associated clinical development plans
  • Design of clinical trials including in-depth knowledge of relevant indication-specific endpoints and use of traditional and novel statistical approaches
  • Development and implementation of biomarker and companion diagnostic strategies
  • Development of indication-specific global or regional regulatory strategies
  • Planning and conduct of expert meetings utilizing PPD’s wide network of key opinion leaders, disease area experts and experienced investigators
  • Use of comprehensive, actionable and realistic feasibility assessments and competitive intelligence to support clinical development planning

Overcome Challenges and Increase Efficiency

PPD’s therapeutic area experts are adept at assisting clients in anticipating and overcoming clinical and regulatory challenges in product development, saving time and enabling the achievement of timely, cost-effective and informed go/no-go decisions.

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