Complementary Practice Areas
Click a Subject Below:
Health Policy Analysis
Examples of some of the questions our policy analyses have answered for our clients include:
- What types of certifications need to accompany regulatory submissions for biologics in different countries?
- How will changes in direct to-consumer advertising legislation affect marketing to consumers and sales of specific biopharmaceutical products across countries?
- Will data from pivotal trials conducted in a foreign country be acceptable to regulatory authorities in any given country?
- Will changes in hospital reimbursement rates for a specific procedure affect the use and sales of a particular medical device?
- Will revision to existing guidances require revisions to clinical trial designs and will ongoing studies need to be amended?
- What are the potential implications of reimbursement of a new expensive treatment for an orphan indication on reimbursement policies for similar products?
- What is the commercial viability of competitor pipelines?
- What is the likelihood of commercial success in various countries of specific competitor products in development?
- What types of marketing strategies have competitors used for specific projects? and have they been successful?
- What types of label claims have been used most often in promotion by competitors?
- Are there any barriers to market entry for competitor products?
- Is a particular competitor likely to be more successful because of a specialty trained sales force?
- Is the clinical development of a particular compound likely to proceed faster due to top-notch laboratory facilities?
- Do the efficacy, safety, and value profiles of competitor products leave obvious treatment gaps?
- Will changing market trends and legislation adversely affect the sales and market access for specific products?
Training & Education
Our experienced and technically qualified staff has assisted our clients in many of their training and development initiatives:
- Health economics and outcomes research training workshops for internal and external stake holders, especially in Ex-US markets
- Presentations and clinical study-related investigator training meetings and workshops
- Presentations to customers and advocacy groups
- Sales representatives and account manger training workshops
- Symposiums for presenting and discussing health economics, outcomes and clinical data
- Company staff training workshops at product launch meetings
We have successfully undertaken all or some of the following components of designing and implementing Phase III clinical studies for our clients:
- Protocol development
- Development of data collection instruments including case report forms for completion by patients, caregivers, physicians or nurses
- Study site identification
- Physician/investigator recruitment
- Investigator training and study monitoring
- Data collection and management
- Data analysis and study report development
- Publication and dissemination of study findings