Biostatisticians are experts in experimental design, in addition to statistics. Therefore, early involvement of a biostatistician can be critical to the success of your product in today’s environment, where evidence of value is increasingly important.
To be effective, a biostatistician must communicate complicated subjects. In many instances the audience has a limited understanding of statistics. Therefore, success often requires an effort that extends beyond sound statistics and beyond the development of a methodologically effective experimental design: success depends upon the ability to craft a report that presents your plan or findings in an understandable and compelling manner to the target audience. American Research Partners will bring this skill to your venture.
•Delivering Efficient Statistical Analysis Plans for Clinical and Preclinical Protocols
•Effective responses to FDA questions regarding statistics
•Designing and conducting Comparative Effectiveness Research (CER)
•Overcoming manufacturing process validation issues
•Completing Statistical Analysis for peer reviewed manuscripts (sponsor and investigator-initiated studies)
•Comparative Effectiveness Research (CER) reports that will persuade payers to endorse your product by presenting a
FDA Submissions and Clearance & Notified Body Submissions
The FDA is becoming more demanding with respect to evidence required for regulatory submissions. American Research Partners has in-house experts and affiliates with proven track records of success. The climate for submissions is in a state of flux. Gaining the ability to access a market is not longer sufficient. Profitability is now dependent upon overcoming health technology assessments/incremental cost effectiveness ratio hurdles to gain approval for reimbursement.
•Post Market Surveillance studies
•Clinical Research Protocols
•Effective responses to FDA questions
•Dossiers and technical files for notified body submissions (CE marking)
Medical Research and Medical Writing
The quality of medical writing is critical to success. The same information can either accomplish your objective or fail to do so, depending upon presentation quality. For example, the articles published in a peer reviewed journal are a reflection of the journal itself and, accordingly, well-written manuscripts are much more likely to make it through the ‘reviewer gauntlet’. American Research Partners will deliver writing skills to your project with a proven track record of success.
•White papers that will assure your potential customers that selecting your product is an excellent option
•Journal article manuscripts that will impress peer reviewers and communicate the value of your product to health care