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
Payer interviews and landscape analysis of real-world data requirements
Innovative contracting report
Development of an Affordability Toolbox
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
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