YLOTI provides a wide range of medical affairs expertise.

Strategy & Business Planning

  • Development of strategy/business plan for products or portfolios
  • Organisation of (virtual) advisory boards and expert meetings
  • Key Opinion Leader (KOL) collaboration and relationship management

Clinical Project Management

  • Portfolio management & overall project management for clinical research in developed and resource-limited countries
  • Design and 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 protocols, informed consent forms, study participant-friendly informed consent summaries, and investigator quick reference cards
  • Input and review of case report forms, monitoring guidelines, safety monitoring plans, statistical analysis plans, and clinical study reports
  • Site selection and feasibility studies
  • Selection, negotiation and oversight of Contract Research Organisations (CROs) 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
  • Establishment of data monitoring committees, and management of consultant contracts and 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 symposia, stand-alone events, or train-the-trainer programs
  • Speaker selection and management of faculty contracts & consultant payments
  • Development of educational websites
  • Booth coverage at medical meetings

Medical Writing & Publications

  • Development of publication plans
  • 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, including intake, review, tracking, change of scope, reconciliation, closeout, and reporting processes
  • Development of communication plans to share metrics and the impact of supported grants

Policies and Standard Operating Procedures

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