With over 20 years of clinical development and project leadership experience, Narus Development Solutions is ready to partner with you to develop and execute strategies to overcome your drug development challenges.
Scott M. White, M.D.
What We Do
Corporate Strategy
Chief Medical or Chief Development Officer
Investor engagement
Scientific advisor and board member selection
Non-dilutive funding through government and NGO grants and contracts
Medical support for business development activities
Academic spinouts
Regulatory Affairs
Pre-IND interactions and IND authoring
LPAD and QIDP
Fast-track designation and priority review applications
Orphan drug status
NDA and MAA submission medical support
Development Strategy
Target Product Profile development
End to end preclinical and clinical development planning
Program gating criteria development
Project leadership
Regulatory strategy
Patient advocacy group engagement
Pharmacovigilance
Medical monitoring of clinical trials, including adverse event and concomitant medication coding review
Rolling data review for safety
Safety review committee and independent data monitoring board charters and staffing
Serious adverse event narrative writing
Development Safety Update Report authoring of medical content
Clinical Development and Operations
Investigators Brochure development
Protocol development
Key opinion leader engagement
Investigator identification and engagement
Vendor selection and oversight
Clinical study reports and data interpretation
Device Development and Manufacturing Support
Clinical support and medical monitoring of device development and testing
Health hazard assessment report development