Pharmacoepidemiology Consulting

We provide consulting support to help our clients focus on critical issues and meet the needs of their internal and external stakeholders. We rely on our deep methodological, therapeutic, and project experience to design studies that align with your study objectives and patient population and meet your budget and timeline.

Our consultants can help you with the following activities:

• Determine if a post-marketing observational study can address a safety issue of regulatory importance
• Design studies or select the best study design after considering alternative approaches
• Select the best source(s) of data from alternatives (e.g., different databases)
• Conduct feasibility assessments for studies using databases or primary data collection or both
• Write study protocols and analysis plans to use in regulatory discussions
• Select analytic approaches, such as those to address issues of nonrandom assignment of drug treatment
• Prepare responses to regulatory questions
• Prepare for regulatory advisory committee meetings
• Negotiate post-approval study commitments

Our team includes persons with advanced degrees in epidemiology, public health, medicine, and biostatistics. We offer deep methodological expertise and project experience in all major therapeutic areas. When you collaborate with us, you gain access to our diverse experience in clinical research, regulatory submissions, and drug safety and epidemiology studies.

Our staff maintain active involvement with thought leaders in pharmacoepidemiology through academic appointments, professional societies, and collaborative projects. We rely on our broad network when helping our clients develop advisory boards or finding specialized expertise for projects.

Whether you require consulting on a specific project or wish to set up a long-term arrangement that allows you access to specific experts on an as-needed basis, we offer flexible contracting arrangements that will meet your needs.