Epidemiology & Real World Evidence: From Development to Approval
Understanding the patterns, causes, and effects of health & disease is key to driving innovation and ensuring successful outcomes at every stage of drug development.
From early-stage research to regulatory submissions, our team offers epidemiological services supporting the target population, creating external controls, cost effectiveness for post-marketing studies, and addressing requirements for health technology assessments.
We offer our biotech partners a range of epidemiological services supporting drug development processes, regulatory approval, post-marketing studies and health technology assessment.
Our US-based biostatisticians work with our clients through flexible Project-based contracts.
Services Include
Gain more precise insights into prevalence, incidence, temporal trends, and comorbidities to better define and target patient populations.
Build and leverage natural disease history and progression models, along with prognostic and predictive biomarkers, to inform trial design and therapeutic strategies.
Assess unmet medical needs, predict market potential, and evaluate the patterns of concomitant medication use.
Identify at-risk populations for monitoring and develop robust statistical models that provide context on the current treatment landscape and demonstrate the public health impact of new therapies for regulatory submissions.
Design post-marketing studies and conduct health technology assessments, including indirect treatment comparisons such as matching-adjusted indirect comparisons (MAIC) and simulated treatment comparisons (STC); compare efficacy of your medication with that of competitors to demonstrate value to health technology assessment regulators.
Apply advanced causal inference methods like propensity score analysis, expert-driven Directed Acyclic Graphs (DAGs), G-estimation, IP-weighting, marginal structural models, and instrumental variables to analyze observational studies and support your evidence-based decision-making process.
PARTNER WITH US
When you work with Inference, you gain a trusted partner with the experience, tools, and dedication to support your clinical development goals. Let us simplify the complexities of incorporating RWEs into the clinical program and beyond so you can focus on delivering impactful therapeutic solutions. Connect with the Inference team to discuss further.
Kalyan Ghosh, PhD
Chief Executive Officer 
Lisa Hickey, MA
Sr. Director, Biostatistics 
Virginia Bellamy, BA
Sr. Director, Data Management 
Roman Torgovitsky, PhD
Consulting Epidemiologist 
Natasa Rajicic, ScD
Biostatistics/Adaptive Design Strategy 
Anindita Bhattacharjee, MS
Sr. Director, Biometrics 
Anuja Mitra, B. Arch
QA and Contracts 
Ankur Mukherjee, PhD
Associate Director - Statistics 
Tanusree Bhattacharyya, MA
US Operations 