The Issue
Sierra understands the difficulty in assembling an experienced management team that is ready on day one of your trial and that can anticipate all issues involved in moving a new medical product through the regulatory maze to the market. While this difficulty is especially acute for start-up companies initiating their first clinical program, large companies with stretched resources frequently require support from experienced professionals to add to their in-house expertise.

The Answer: Sierra MRC
Sierra's consulting division, Sierra MRC, combines with CRIS to provide the most comprehensive offering of products, services and expertise to the FDA-regulated medical products industry. The scientists and medical experts at Sierra MRC bring more than 50 years in successful, direct experience to the planning, development, execution and analysis of clinical research programs.

Sierra MRC Services
Whether you are beginning to plan your next trial, have made headway into Phase 2, or are ready for a pivotal trial, leverage one or more of Sierra MRC's services to maximize your results.

• Evaluating business plans and development programs.
  
  
• Reviewing and evaluating product development data (pre-clinical and clinical).
  
  
• Evaluating staffing and organizational structures of developing companies.
  
  
• Ongoing consulting and/or project management for new products.
  
  
• Developing and reviewing clinical and regulatory strategies, including negotiation with regulatory bodies.
  
  
• Developing and reviewing clinical protocols and regulatory submissions.
  
  
• Establishing alliances with qualified consulting organizations where outsourcing is appropriate.

Click on the following links to read examples of common issues facing early-phase organizations that can be addressed through Sierra MRC, and for PDFs of Sierra's recent white papers.

To find out how Sierra MRC can enhance your in-house expertise, contact us for a consultation.