Healthcare stakeholders must look beyond anecdotes to support their decisions and value propositions.  Verifiable, replicable and statistically significant datasets are generated through studies.

Studies in turn support clinical decision-making, reimbursement, standards of care, practice growth, product development and regulatory compliance.

Real-World Studies

A good study design unites clinical/scientific hypotheses with corresponding outcomes data.  The “gold standard” for studies has traditionally been the randomized, controlled, double-blinded trial – the RCT.
However, the U.S. Department of Health and Human Services has recognized that other forms of study formats are often superior. Real-world studies are now mandated for many purposed by national legislation and healthcare regulators.
. . . .Studies derived from well-designed and well-performed patient registries can provide a real-world view of clinical practice, patient outcomes, safety, and clinical, comparative, and cost-effectiveness, and can serve a number of evidence development and decision-making purposes. . . .

U.S. Department of Health and Human Services.  Agency For Healthcare Research and Quality, 2020

Challenges With Traditional Studies

RCT’s are beyond the budget and capabilities of all but the largest product manufacturers or research centers. Moreover, such studies are often less useful for many broader population segments, depriving patients of many safe and efficacious treatments.
Real-world studies include pragmatic, n of 1, investigator-initiated, practical and other formats.

Study Design

An efficient and value-added study begins with its design.  Circles integrate clinical/scientific expertise, longitudinal observational protocols, inclusion/exclusion criteria, statistical significance and scalability.  Designs can be as simple or complex as desired by Investigators and Sponsors.

Study Execution

Many studies fail due to poor execution of good designs.  Circles enable efficient data collection/aggregation, multi-center administration, data auditability, multi-lingual support, regulatory compliance, robust report generation, data control/security and 24/7 accessibility.

Funding

Studies typically involve products or procedures of interest to commercial or not-for-profit funding sources.  Those sources may provide funding as Sponsors, or support studies through “Investigator Initiated Trials”. Circles represent an efficient and ethical path between Investigators and Funders.

Learn more

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