Clinical Affairs Services

Optimize your path to regulatory approval by leveraging our unparalleled clinical affairs and development expertise

Cardinal Health Regulatory Sciences understands the importance of timely, high-quality and cost-effective clinical development. That’s why our experts integrate clinical development services and clinical research services to help you reduce risk and optimize your pathway to product approval. Our clinical trial services help clients ensure scientific integrity and compliance with applicable regulations and quality standards.

Our suite of clinical affairs services includes

  • Clinical development services and planning
  • Clinical trial consulting, design and protocol development
  • Medical writing services
  • Due diligence assessment and gap analysis
  • Interfacing with industry experts and regulatory authorities

Our suite of clinical operations services includes

  • Clinical trial and consulting services, including management and monitoring
  • Clinical research organization and vendor qualification and management
  • Trial master file creation and maintenance
  • Clinical quality compliance audits, including Good Clinical Practices (GCP) and pharmacovigilance (PV) audits
  • Standard operating procedure (SOP) development
  • Training program development
  • Project management

Our suite of clinical pharmacology services includes

  • Outline and design of clinical studies
  • Animal to human extrapolation
  • Traditional and adaptive designs for first-in-human (FIH) and proof-of-concept (PoC) clinical trials and later phase trials
  • Pharmacokinetic/pharmacodynamic (PK/PD) modeling, simulation, analysis and reporting
  • Optimization of dosing regimen and sampling times


Our experts can help. Learn how.

Learn more about our how our clinical research services can accelerate your drug’s path to approval. Contact us today.

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