Stem Cell Therapies: Clinical Development

IDSC's clients come to us for our clinical development expertise in stem cell therapies.  We help get them from IND to launch supporting them with clinical development, clinical operations, regulatory compliance and FDA meetings, strategic planning and budget planning, and market assessment and valuation.  With stem cell therapy being such a rapidly evolving science with differing regulatory environments worldwide, our clients appreciate a "go to"  company like IDSC to help navigate the path for them.

Clinical Development

IDSC's experienced clinical development directors help our clients to:

 

  • Establish and manage clinical advisory boards, drug safety and monitoring boards, and clinical endpoint committees
  • Identify and utilize KOLs
  • Determine the clinical pathway to registration
  • Develop cost projections for their clinical program
  • Design their clinical protocols
  • Manage their clinical program and trial execution
  • Ensure nonclinical studies & other activities align with their clinical plan & regulatory requirements

Regulatory Compliance

IDSC's stem cell therapy clients come to us for regulatory support.  We help them:

 

  • Optimize their regulatory strategy
  • Ensure their program activities and goals are aligned with their regulatory strategy
  • Prepare the appropriate regulatory documentation
  • Create and deliver their regulatory submissions
  • Prepare for meetings with regulatory agencies

Strategic Planning

Our directors have years of experience in strategic planning, and in the area of stem cell therapy, we help our clients by:

 

  • Guiding the development of the company strategy:
    • Establish a business plan integrated across R&D, manufacturing and clinical lines
    • Set and track company goals, timelines, budgets, and milestones
  • Identifying and overseeing external vendors
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