Complementary Practice Areas

Development of Avalon’s complementary practice areas was largely driven by client need. Staying true to our philosophy of being the preferred “one-stop” solution provider for our clients over the past 12 years, we have developed expertise and practice capabilities to support our clients in achieving critical milestones throughout the product life cycle.

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Health Policy Analysis
We have conducted critical appraisals and reviews of current and impending healthcare legislation, policies, and guidances issued by regulatory authorities in US and EX-US markets. Our policy analyses have been instrumental in enabling our clients anticipate the consequences of healthcare policies and mandates for pharmaceutical, biotechnology, and medical device companies.

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?
Competitive Intelligence
At Avalon, we have developed expertise in assisting our clients utilize competitive intelligence in product strategy and decision making. Using public information and proprietary databases, our projects have supported our clients in clarifying the following types of questions:

  • 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
Clinical Research

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
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Therapeutic Areas

  • Anti-infectives
  • CNS
  • CVS
  • Dermatology
  • Endocrine and Metabolic Disorders
  • GI Disorders
  • Oncology
  • Ophthalmology
  • Organ Transplant
  • Pain
  • Respiratory