Medical Affairs

Our Medical Affairs services are structured in the form of an annual subscription, plus consulting hours through our biostats team. Clients work with our biostats team to develop a research plan to explore key questions of interest on their brand or competing brands. Our access to competitor brand data are unique – most other data sources do not provide this information. Typically our research culminates in the form of an abstract in a medical specialty conference, or manuscript published in a major medical journal . Examples of the services we offer in Medical Affairs include:

  • Comparative Effectiveness Research (CER)
  • Comparative Drug Safety Analysis
  • Time to Event Analysis
  • Patient Clinical Profile of New Users
  • Matched Analyses of Populations within the Registry or External Datasets
  • Changes in DMARD therapy including reasons for change. These data are collected along with clinical and patient outcomes at the time of therapy change, patient demographics and patient clinical history.

Our biostatistics and epidemiology team has the methodological expertise to answer all your Medical Affairs questions.

Safety Analysis

Example: Provide comparison event rates in US registry populations, including sub-population analyses using subscriber-developed selection criteria.

Time to Event Analysis

Example: Calculate time to initiation or switch of biologic treatment under conditions defined by the subscriber.

Comparative Effectiveness Research

Examples: CER analysis of single agent to another biologic class, or CER analysis of single agent to other single agents, or treatments within the same class.

Drug Profile

Example: Provide detailed descriptive analysis of patients on a specific drug or class regimen which include demographics, clinical characteristics, concomitant medication use, and switching behavior.

Matched Analysis

We assure that appropriately matched populations can be used for comparisons of agents in a unique therapeutic niche. These comparisons are performed by our experienced biostatistical team using the most appropriate technique to maximize statistical power, examples include propensity matching and propensity trimming techniques.

Descriptive Analysis

Examples: Analyses of the Corrona registry population which describe clinical and treatment characteristics within sub-populations: Examples include descriptive analyses of patients initiating their first biologic, patients meeting specified demographic or clinical criteria for a particular outcome of interest or a very large variety of uniquely defined and segmented populations.