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Clinical Research

Optimize your path to commercialization by leveraging clinical research and development expertise

Cardinal Health Specialty Solutions integrates clinical development planning and clinical research operations to help you reduce risk and accelerate development. We provide clinical trial consulting services to help clients ensure scientific integrity and compliance with applicable regulations and quality standards. We understand the critical importance of timely, high-quality and cost-effective development of your products and strive to optimize your pathway to product approval.

Clinical development

We ensure successful product development using strategic clinical development planning and by leveraging our team’s experience in clinical pharmacology, research and operations across all major therapeutic areas.

Clinical research

  • Clinical development planning
  • Clinical trial design and protocol development
  • Medical writing services
  • Due diligence assessment and gap analysis
  • Identification and management of key clinical resources and thought leaders
  • Interfacing with industry experts and regulatory authorities

Clinical operations

  • Clinical trial 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 programs
  • Project management

Clinical pharmacology

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

Stan McDermott, PharmD, MS, RPh

Managing Director, Clinical Research

Kathy Scott, BS

Kathy Scott, BS

Principal Scientist, Clinical Research

Clinical Development Programs

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