Other project experience

  • Development of a payer discussion guide for new in-license opportunities
  • Review of payer advisory board toolkit materials
  • Consultation on the difference between QoL and QoLIES and their usefulness in regulatory submissions and reimbursements
  • Review of evidence requirements for reimbursement submissions in northern and central Europe
  • Advice on ethical issues in health economics
  • Evaluation of the effectiveness of a referral management intervention on GP-referred outpatient planned care
  • Evaluation of the economic section for the Full Applications to a Personalized Medicine Contest
  • Questionnaire design and data analyses for cost of illness in Germany and the UK
  • Cost of illness review for 54 different diseases
  • Training session on health economics and outcomes research (HEOR)
  • Introductory training and slides on a Health Survey
  • Value strategy training on access to medical devices
  • Provision of support materials for the client’s health care sales meeting and training on material usage
  • Stakeholder interviews (KOLs and payers) in Algeria, Costa Rica, Ecuador, Morocco, Panama and Romania
  • Strategic HE advice on early HTA process
  • EU market access training workshop
  • HEOR strategic consulting
  • Landscape assessment of real-world data sources and impact on reimbursement decisions
  • PRO strategy for observational studies
  • Development of a white paper on PROs in labelling and promotion
  • General consulting in PROs
  • Educational programme in productivity and other PROs
  • Statistical educational series for PROs
  • Support for Advisory Board meeting for Patient-Reported Outcome Excellence Project
  • Analysis, reporting and literature research on the influence of PROs in regulatory approval in China and Japan
  • Understanding the regulators perspectives for a successful submission of PRO data
  • Internal lecture on the use of PRO and HE in the development and commercialisation of drugs
  • Generic quality of life questionnaire, protocol review and providing initial feedback
  • Panel and presentation on PRO research on medical devices
  • Literature review of newly developed PROs in 5 specific disease areas
  • Presentation of a paediatric PRO training workshop
  • Consultancy and training in all aspects of PROs
  • Training on the importance of PROs and a slide deck detailing operational issues in PRO assessments
  • Development of a decision algorithm for incorporating PROs into clinical trials
  • PRO training and presentation
  • Training course on PROs in clinical research and regulatory submission
  • Workshop on draft PRO guidance for the FDA
  • PRO guidance presentation to health authorities
  • Development of a patient acceptability questionnaire for oral paediatric drugs
  • Consultancy on the protocol to compare the responsive reaction of patients between a traditional paper-administered questionnaire and an electronic touch screen device
  • Questionnaire development and testing for the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program
  • Training in productivity measurement
  • Workshop to provide methods and strategic insights into linguistic validation of clinical outcomes assessments
  • Interviews and development of a patient acceptability questionnaire for oral paediatric drugs
  • Systematic review workshop
  • FDA advisory panel
  • Workshop on the Final Guidance to Industry
  • Development and presentation of an internal webinar on tolerability
  • Lecture on quality of life
  • Workshops at the Worldwide Outcomes Research Forum
  • Lecture on the use of the placebo effect in drug development
  • Mixed methods training session including Rasch and Item Response Theory Methodology
  • Development of a market access toolkit for China, South Korea and Taiwan
  • Analysis of market access knowledge gaps in Asia
  • Critical review of a systematic review report written in NICE submission style
  • Evaluation of the Japan Medical Data Center Database and comparison to medical data vision for combination use
  • Literature review, instrument review and database evaluation in 5 pathologies