Clinical Development Services

Investigative New Drug (IND) Application (Regulatory approval to test in humans)

  • Develop the document or give scientific advise/review to ensure the following points are presented
    • Credible expectation that compound will benefit patients 
    • Evidence that the compound will not be toxic at therapeutic dose
    • Demonstration of a means of controlled chemical synthesis of clinical-quality drug substance
  • Plan and execute early clinical programs to meet aggressive project timelines with limited resources for both biologics and small molecules

 

Phase I Clinical Trials (Safety and PK) and Phase II Clinical Trials (POC and dose selection)

  • Provide project management and oversight of all CRO activities.
  • Develop phase 1 clinical trial protocols and investigator’s brochure
  • Additional expertise is available in the form of:
    • Regulatory Affairs guidance & consulting
    • Medical Affairs
    • Clinical Trials Management/Operations
    • Clinical PK/PD
    • Biostatisticial Analysis 
  • Study design to validate TPP

Where to Find Us:

BusStim

Business Stimulant Consultants, LLC

3240 Henry Hudson Parkway

Suite 7E

Riverdale, NY 10463


Phone: 917-482-5642

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