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 drug donation programmes
- Management of investigator-initiated studies
- Development of study documents, including protocols, informed consent forms (ICF), study participant-friendly informed consent summaries, and investigator quick reference cards
- Input and review of case report forms (CRF), 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 and inspections
- Establishment of data monitoring committees, and management of consultant contracts and payments
- Study Responsible Scientist; serving as primary point of contact for medical questions, and review of medical listings and coding reports
- Comprehensive financial management and budget tracking
Medical Education
- Development and execution of educational strategies, platforms and programmes
- Development of content and training materials (slides decks / posters) for symposia, stand-alone events, or train-the-trainer programs
- Speaker selection, faculty contract management, and consultant payments
- Development of educational websites
- Medical booth coverage at international congresses
Medical Writing & Publications
- Development of publication plans
- Writing, editing and proofreading of study protocols, clinical study reports, manuscripts, slide decks, and posters
Sponsorship & Grants management
- Development of sponsorship and grants plan
- End-to-end 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 strategic impact of supported grants
Policies & Standard Operating Procedures
- Development, review, and revision of policies and/or standard operating procedures (SOPs)