Disease Diagnostics Development Services

IDSC offers its disease diagnostic clients preclinical and clinical development consulting services in the areas of strategic planning, regulatory compliance, clinical development, and market assessment.  As with all of the products that our clients develop, we guide our clients with diagnostic assets through the regulatory path and help them develop their regulatory strategy.

 

Many of IDSC services in the diagnostic area are listed under the headings below.  However, in addition to specific consulting services around regulatory & clinical strategy and market assessment, our clients come to us for the following key steps in their development process:

 

  • Draft a program review
  • Draft a gap analysis
  • Draft a preclinical and/or clinical development plan

Regulatory Compliance

IDSC's 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

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

Strategic Planning

Our directors have years of experience in strategic planning, and in the diagnostics area, 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
    • Generate an exit strategy
  • Identifying and overseeing external vendors

Market Assessment

Our clients come to us for a number of market assessment, due diligence, and valuation services including:

 

  • Evaluate client asset
  • Determine market size and potential market penetration
  • Gather competitive intelligence
  • Position client to manage negotiations with investors/ partners in order to receive highest value for their asset
  • Performing product valuations are not just in the domain of "big-pharma"
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