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CRS Lin

HOW WE CAN HELP

SERVICES

 We can help you rapidly advance your entire clinical development and trials lifecycle in support of:


  • CEO/COO corporate start-up, corporate operations
  • clinical development plans
  • CRO selection and management
  • strategic business plans
  • bid defenses
  • program management
  • regulatory requirements, gap analysis
  • face-to-face negotiations and written communications with the FDA, Health Canada, and Competent Authorities
  • IND Regulatory Agent for FDA
  • trial planning, efficiency, and operations
  • selection and management of clinical trial sites and investigators
  • medical and scientific advisory boards
  • patient recruitment and enrollment rates
  • engagement with key opinion leaders and investigators
  • fair market value rates
  • business ethics and corporate compliance
  • patient input
  • clinical endpoints for labeling claims, market adoption, and reimbursement
  • expectations of all stakeholders
  • risk assessment and management
  • realistic costs and timetable projections
  • quality assurance
  • resourcing decisions and recruiting
  • HR documentation, on-boarding, job descriptions, organizational policies and manuals
  • contract management
  • vendor selection and management
  • ​business development and RFP/RFQ generation
  • white papers and presentations
  • team training, workshops and seminars on regulatory and ICH-GCP topics through CRS Academy
  • due diligence
  • draft and revise SOPs
  • EHR-to-EDC interoperability


  Pricing can be tailored for a limited budget and/or for project specific milestones.

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