Research

RESEARCH 

We help industry partners to design and assess clinical trials and to accurately measure the prevalence of pertinent health conditions so that they can determine the market for drugs.  For drugs that are already in use, we design appropriate post-marketing surveillance studies and help industry partners respond to regulatory agencies.  Specific research activities are: 

1. Epidemiological Analysis for Pharmacovigilance (PV):

a. We respond to epidemiologic questions as needed.  We are always “on call” for our industry partners. 

b. Utilize epidemiology data and methods to assist with content produce Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMs), and respond to regulatory agencies and other health authorities. 

c. Develop the strategy and design of post-marketing safety and effectiveness studies, including studies of relevant sub-populations and registries. 

d. Assist in the interpretation of post-marketing surveillance data and investigate rare exposures and outcomes utilizing observational epidemiological methods.  

e. Develop content for journal publications and conferences. 

2. Epidemiological Work for non-PV Units

a. We provide epidemiological support for other units as needed, such as Clinical Trials, Medical Affairs, and Value and Real World Evidence.

b.Conduct health outcomes and epidemiology research studies on topics of mutual interest, utilizing industry partner databases or other population-based databases as appropriate. 

c. Utilize the expertise of Columbia’s clinical, translational, and research faculty from the College of Physicians & Surgeons and other schools to answer specific questions in nephrology, psychiatry, neurology, oncology, gastroenterology, and other disciplines. 

d. Assist with new and ongoing studies to optimize design, analysis, writing, and ultimate poster and paper presentation. 

e.Establish writing workshops to improve writing skills and paper preparation for industry employees. 

f. Facilitate participation of students and trainees in industry collaborations to create a training pipeline: these trainees often become future interns and talented hires for industry partners.