Post-Marketing, Pilot, and Other Studies

Animal health companies conduct post-marketing studies, also known as Phase 4 studies, for a number of reasons. Studies run under “real-life” clinical practice conditions can provide:

• Experience with newly approved products
• Additional safety-related data derived from a broader population than that studied in the clinical development program
• Assessment of particular parameters defined by the Sponsor’s post-marketing protocol
• Comparative product information to demonstrate a given product’s performance and/or economic benefits in comparison to a competing product
• Expanded in-clinic use of a given product
• Assessment of particular parameters defined by the Sponsor’s post-marketing proto

It is important that post-marketing studies are conducted in accordance with scientifically valid protocols and in a manner that provides reliable study outcomes that can withstand the rigorous scrutiny of the scientific community, (e.g. animal health scientific publications), and, in cases in which studies compare competitive products, a given Sponsor’s competitor(s).

Activities in support of post-marketing studies include:

• Developing protocols and case report forms
• Developing study-specific SOPs (Standard Operating Procedures) in consultation with the Sponsor
• Identifying, qualifying, and training investigators
• Identifying Key Opinion Leaders
• Preparing and producing investigator manuals, casebooks, owner diaries and supporting materials
• Optimizing patirnt recruitment
• Managing investigator and owner reimbursement
• Data management including developing the study database and entering study data and developing and maintaining study files
• Managing the study
• Reporting on the study, including assisting with study-related publications and other deliverables

To request more information on AlcheraBio’s Contract Research services in the area of post-marketing studies, please click here.