Regulatory RWE Consulting

As researchers with advanced degrees in epidemiology, public health, biostatistics, and medicine who have hundreds of combined years of applied experience, we can provide you with reliable, informed, and expert consulting advice and deep methodological and project experience in all major therapeutic areas

Our diverse background in clinical research, regulatory submissions, epidemiology studies, and drug, vaccine, and medical technology safety and effectiveness enables us to align the right approach with your objective. Our consulting experience includes:

  • Preparing for regulatory advisory committee meetings
  • Preparing responses to regulatory questions
  • Negotiating post-approval study commitments
  • Determining if a post-marketing observational study could address a safety issue of regulatory importance within a risk management plan
  • Designing studies to evaluate the effectiveness of risk minimization measures within a risk management plan
  • Performing regulatory landscape analyses to help guide clients in product development for specific therapeutic areas—especially rare diseases, novel therapeutic areas, devices, and combination products
  • Selecting the best study design among alternative approaches
  • Selecting the appropriate data collection strategies and data source(s) among alternatives
  • Conducting feasibility assessments for studies using databases and/or primary data collection
  • Developing study outlines, synopses and writing study protocols and analysis plans to use in regulatory discussions
  • Advising on benefit-risk assessment methods for specific products
  • Selecting analytic approaches, such as those to address issues of nonrandom assignment of drug treatment
  • Providing training on epidemiology methods, benefit-risk assessment, and regulatory requirements in pharmacoepidemiology
  • Conducting epidemiological research related to pregnancy

Based on your needs, we provide consulting support for specific projects or can set up long-term arrangements that allow access to specific experts on an ongoing basis. For example, numerous researchers serve on and sometimes chair project advisory boards and data safety monitoring committees for long-term projects.