Clinical & Pharmacoepidemiology

Thought leadership

Leveraging Public Healthcare Data for Post-Market Surveillance, Market Research, and Generating Clinical Evidence for the Life Sciences Industry

Ģ��tv's multidisciplinary teams of epidemiologists, statisticians, clinicians, and clinical toxicologists provide the expertise needed for the rigorous conduct and evaluation of clinical epidemiology and pharmacoepidemiology studies.

Our teams are highly skilled in the design and analysis of clinical trials, meta-analysis of treatment effects, evaluation of spontaneous reports of adverse events, and pre-and post-marketing safety assessments using clinical trial data.

Our observational pharmacoepidemiology studies provide "real-world" assessments of potential short-term and long-term benefits and adverse drug events in populations with a more diverse range of providers, patient health status, and demographic characteristics.

How does sound science influence our pharmacoepidemiology safety studies?

We regularly perform pharmacoepidemiology safety studies designed to identify the types and frequency of adverse events associated with a given agent to determine reasons that may explain the adverse events and seek to address the following questions:

Are the events dose-related?
Does the pharmaceutical agent interact with other medications or substances to promote adverse events?
Are certain high-risk subpopulations or pertinent lifestyle factors related to the event?
Is the pharmaceutical agent being used in accordance with label instructions?

Summary of Research & Consulting Capabilities

We have provided clinical epidemiology and pharmacoepidemiology consulting services on numerous projects. Our research spans disease prevention, screening, diagnosis, management, prognosis, and patient-centered outcomes.

- Cardiovascular disease risk among women using dietary supplements
- Liver failure risk among users of anticonvulsants
- Clinical and economic impacts on asthma and COPD of a new respiratory bronchodilator
- Effectiveness of adding omega-3 supplements to the diet
- Assessment of potential patient population size for proposed orphan drug application and filing of a Pediatric Investigation Plan
- Epidemiologic evaluation of factors influencing patterns of care in chemotherapy treatment for common female cancers
- Descriptive epidemiologic characterization of various childhood bone disorders for assessment of populations in need of treatment for these rare childhood diseases
- Epidemiologic characterizations of rare blood disorders in the general population
- Meta-analysis of prognostic factors after liver resection in metastatic colorectal cancer
- Risk of urothelial carcinoma with implanted medical devices
- Our epidemiologists and statisticians have published numerous peer-reviewed scientific papers on topics related to clinical epidemiology and pharmacoepidemiology, including drug therapies, medical devices, healthcare access and costs, pharmacovigilance and surveillance, meta-analysis, and methodological issues.

Our Capabilities Are Unparalelled

With expertise in over 90 disciplines and hundreds of capabilities, tools, and methodologies — we get to the root of even the most complex challenges and give you the objective answers you need.

Young patient going into MRI machine. Ģ��tv evaluates the safety, performance, biocompatibility of medical technology.

Experts

Our global and comprehensive expertise across industries gives us a deep understanding of current challenges, best industry practices, and the implications of emerging technologies.