YLOTI provides a wide range of medical affairs expertise.

Strategy & Business Planning

  • Development of strategy/business plan for a product or portfolio
  • Organization of (virtual) advisory boards and expert meetings
  • KOL collaboration and relation management

Clinical Project Management

  • Portfolio management & overall project management for clinical research in developed world as well as in resource-limited countries
  • Design & execution of phase I-IV clinical studies
  • Development of pre-approval, post-study and donation programs
  • Management of investigator initiated studies
  • Development of study documents, such as protocol, informed consent, study participant-friendly informed consent summaries, investigator quick reference cards
  • Provide input and review of case report forms, monitoring guidelines, safety monitoring plan, statistical analysis plan, clinical study report
  • Site selection and feasibility study
  • Selection, negotiation and oversight of CRO and other vendors
  • Protocol and product training for CRAs and study site staff, as well as organisation of study investigator meetings
  • (Co-)monitoring and preparing investigational sites for audits/inspections
  • Set-up of data monitoring committee, and management of consultant contracts & payments
  • Study Responsible Scientist; point of contact for medical questions, review of medical listings and coding reports
  • Financial management

Medical Education

  • Development and execution of educational strategies, platforms and programs
  • Development of content and training materials (slides decks / posters) for symposium, stand-alone, or train-the-trainer events
  • Speaker selection and management of faculty contracts & consultant payments
  • Development of educational websites
  • Booth coverage at medical meetings

Medical Writing & Publications

  • Development of publication plan
  • Writing, editing and/or proofreading of study protocols, clinical study reports, manuscripts, slide decks, and posters

Sponsorship & Grants management

  • Development of sponsorship & grants plan
  • Management of sponsorship and grant requests, such as intake, review, tracking, change of scope, reconciliation, closeout, and reporting processes
  • Development of communication plan to share metrics and effect of supported grants

Policies and Standard Operating Procedures

  • Development or revision of policies and/or standard operating procedures