Clinical Development

An effective clinical strategy, together with appropriate clinical program design, is essential for successfully moving a project from candidate identification to IND and from IND through phase I, phase II, and phase III clinical trials. To help our clients with strategic and tactical direction through these critical phases in their development, we have put together a team of seasoned clinical development experts. We assist with a full range of services, including strategic planning, regulatory expertise, clinical study design and execution. IDSC assists clients to produce the right clinical design to address the needs of their program. IDSC's clinical staff provides high quality clinical development services in the following areas:

• Production of a clinical development plan and protocol development
• Review of Statistical Analysis Plan (SAP)
• Interpretation of study results, including review/interpretation of issues arising during conduct of studies
• Writing of clinical study reports and integration of reports for regulatory submission
• Program and project management
• Patient recruitment and retention
• Investigator and site selection
• Global regulatory strategy, submissions, and meeting preparation
• Competitive intelligence
• Medical affairs planning and support

Currently IDSC is accepting clients needing clinical support for their antibacterial, antifungal, CNS, and cardiovascular programs.