Services in clinical development and operations

Services in clinical development and operations

  • Feasibility Services for Patient Recruitment
  • Regulatory Affairs Management 
    • Clinical Trial Application (CTA)
    • Study start-up support (CA & IRB/(I)EC) submissions all phases
  • Clinical Trial Agreements and Insurance
  • Clinical Project Management and Trial Management (phase I-IV studies)
  • Clinical Monitoring (phase I-IV studies)
  • Interim Management
  • Temporary support during dynamic periods of transition or change within an organization
  • Management support and Lean processing for function building (re)design in an organization
  • Trouble-shooting, intermediary, interface management when e.g. , vendor alignment expectations are not met
  • Coaching & training
  • Writing Standard Operating Procedures (SOP) and Working Instructions for Project Management, Monitoring, Out- and Insourcing, Vendor Management and Governance
  • Working and support in a Virtual concept (team management)