Real-World Data

At Biotrial, we recognize the transformative impact of Real-World Data (RWD) in advancing clinical research and enhancing patient outcomes. Our comprehensive RWD services are designed to bridge the gap between controlled clinical trials and everyday clinical practice, providing actionable insights that drive informed decision-making throughout the drug development lifecycle.​

Real world data
real world data- Biotrial

Understanding Real-World Data

Real-World Data involves health-related information collected outside the confines of clinical trials. This includes routinely collected data from electronic health records (EHRs), insurance claims, patient registries, as well as secondary use of data from cohort studies or previous clinical trials.

Biotrial Real-World Data services

External Control arm

Secondary use of existing data to generate early evidence of treatment efficacy and speed up drug approval

Target trial emulation

Application of advanced causal inference methods to emulate a target trial from observational data

Public data base study

Leverage public database (e.g., SNDS, PMSI, ESND) to generate insights on disease burden and treatment pathways

Epidemiology

Custom designed studies-descriptive or casual – to understand the natural history of disease.

Evidence synthesis

Indirect treatment comparisons using individual or aggregated data (e.g., Matching- adjusted indirect comparison, Network Meta Analysis)

Benefits of integrating Real-World Data

  • Explore high medical unmet needs and understand treatment patterns: To describe disease epidemiology and understand treatment patterns, including standards of care and lines of therapy.
  • Assess the impact of eligibility criteria: To optimize eligibility criteria, improving enrolment rate and enhancing trial inclusivity across diverse populations.
  • Support label expansions or revisions: To enable research on specific subgroups or populations underrepresented or excluded from clinical trials.
  • Assess treatment effectiveness: To provide insights into how treatment performs in real-life settings (i.e., treatment effectiveness) compared with clinical trial efficacy.
  • Demonstrate treatment efficacy: To be incorporated into the design of a single-arm trial to generate early evidence of treatment efficacy- an approach that is increasingly recognized and valued by regulatory authorities when placebo arm is not feasible.

Why choose Biotrial for Real-World Data services?

With extensive experience in clinical research and a deep understanding of data analytics, Biotrial is uniquely positioned to harness the power of Real-World Data. Our multidisciplinary team collaborates closely with clients to develop customized RWD strategies that address specific research objectives and regulatory requirements.​
Partner with Biotrial to leverage Real-World Data in your clinical development programs, enhancing the relevance and applicability of your research findings, improving patient outcomes, and supporting regulatory decision-making.

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