consultant

Solutions2Projects is focused on providing IT strategy and IT compliance services for life sciences companies moving towards commercialization or in support of commercialization initiatives.  At Solutions2Projects, we believe that the IT technology and system strategy should be aligned with the corporate strategy to reduce the time to market and optimize business processes. 

Terri started Solutions2Projects, LLC in 2005 after being laid off from her second biotech company in three years and has been successfully consulting with biotech, medical device, diagnostic, and digital health companies, primarily in the San Francisco Bay Area, ever since.  Prior to Solutions2Projects, LLC, Terri worked for Coulter Pharmaceuticals (acquired by Corixa Corp.) and Cell Genesys, both based in South San Francisco. 

services include

  • IT strategy development
  • IT compliance (SOX, FDA, EU)
  • Data privacy (FDA, GDPR)
  • System selection advisory
  • Project management advisory
  • Vendor audits
  • Computer validation advisory
  • Digital health advisory

Installations

  • SaaS
  • On-Premise
  • Externally Hosted

system areas of expertise

  • Budgeting/planning (BPM/EPM)
  • Clinical trial management systems (CTMS)
  • Complaint handling
  • Deviation Management/CAPA
  • Electronic document management systems (eDMS)
  • eProcurement
  • ERP/MRP
  • Equipment maintenance / calibration
  • HRIS/HRMS
  • NCMR/CAPA
  • Payroll
  • Product lifecycle management (PLM)
  • Quality control (QC)
  • Quality management systems (QMS)
  • Regulatory (RIMS)
  • Serious adverse events (SAE)

past clients

  • AcelRx
  • Achaogen
  • Alexza Pharmaceuticals
  • Cholestech
  • Comentis
  • Five Prime Therapeutics
  • Fluidigm
  • Gener8
  • HealthTell
  • HemoSense
  • Hyperion Therapeutics
  • Ista Pharmaceuticals
  • Pacific Biosciences
  • Paradigm Management
  • Pharmacyclics
  • Proteus Biomedical
  • Stanford Medicine
  • Tethys
  • Theravance
  • Tobira
  • Topcon Medical
  • XenoPort
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