Real-World Evidence with Transparent Methods

Some questions are difficult to answer through controlled trials alone: How does a disease progress? How are patients treated in practice? What outcomes occur over time? Real-world and observational data help answer these questions. ACRO designs and conducts observational studies and develops and analyzes patient registries to generate primary evidence on epidemiology, treatment patterns, outcomes, and safety, with transparent methodology from the outset.

Why it matters

Real-world evidence (RWE) has become central to regulatory, reimbursement, and clinical decision-making. The value of observational research depends on controlling bias and confounding. Prespecified designs, appropriate analyses, and transparent reporting under STROBE and RECORD distinguish reliable evidence from post hoc data exploration.

What we offer

Observational & real-world studies

  • Retrospective cohort, case-control, and cross-sectional studies
  • Disease epidemiology and burden-of-illness studies
  • Treatment pattern and drug utilization studies
  • Clinical outcome and patient-reported outcome (PRO) studies
  • Real-world safety studies and post-marketing surveillance

Patient registries

  • Registry design and protocol development
  • Data models, common data elements, and eCRF development
  • Enrollment, data collection, and quality management frameworks
  • Data governance, consent, and regulatory compliance
  • Registry analysis — Descriptive, longitudinal, and clinical outcomes
  • Registry-based natural history studies

How we work

We begin with the research question and work back to the appropriate data source and design. Protocols and analyses are prespecified, confounding is addressed using appropriate methods, and findings are reported transparently under observational research standards. Projects requiring an external control arm or indirect comparison are supported through Data Use & Regulatory Strategy.

Related services

  • Publication Support — Real-world studies developed with academic publication in mind.
  • Data Use & Regulatory Strategy — External control arms and indirect comparisons for regulatory use.