Turning Data Into Evidence

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

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

Study Design

Study Execution

A proper study design will include one or more well-defined clinical/scientific hypotheses, end-points, inclusion and exclusion criteria, population size, duration, outcomes measures, bases for statistical and clinical significance, data verification, adverse event monitoring, proper consent forms, and other elements.

Study execution involves investigator selection, training and coordination; patient enrollment and follow-up; longitudinal monitoring; legal/regulatory compliance; electronic clinical report forms (e-CRF’s); secure yet accessible database architecture; robust reporting tools and other elements.

Challenges With Traditional Studies

The Power of Real-World Evidence 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.

Recognizing this, policymakers, regulators and payers have focused on the importance of studies based on real-world evidence.

Modern healthcare is witnessing a powerful movement in favor of “pragmatic”, “n of 1”, “hybrid”, “investigator-initiated” and other forms of studies and trials based on real-world evidence.  The 2021 American Cures Act, U.S. “Right-to-try” laws, European Medicines Agency post-market-surveillance requirements, “value-based” medicine and accountable care organizations are all examples of the demand for studies based on real-world studies and trials.

Study Design

A proper study design will include specific clinical/scientific hypotheses, end-points, population definition (inclusion and exclusion criteria), population size, duration, outcomes measures and scoring protocols, bases for statistical and clinical significance, data verification, adverse event monitoring, proper consent forms, and other elements.

Study Execution

Study execution involves investigator selection, training and coordination; patient enrollment and longitudinal compliance; ongoing monitoring; legal/regulatory compliance; electronic clinical report forms (e-CRF’s); secure yet accessible database architecture; robust reporting tools and other elements.

Traditional Challenges With Traditional Studies

Until recently, clinically-significant studies were beyond the budget and capabilities of all but the largest product manufacturers or research centers.  Traditional study complexity is a major factor in increasing healthcare costs.  Moreover, they are often less useful for broader population segments, depriving patients of many safe and efficacious treatments.

The Power of Real-World Evidence Studies

Modern healthcare is witnessing a powerful movement in favor of “pragmatic”, “n of 1”, “hybrid”, “investigator-initiated” and other forms of studies and trials based on real-world evidence.  The 2021 American Cures Act, U.S. “Right-to-try” laws, European Medicines Agency post-market-surveillance requirements, “value-based” medicine and accountable care organizations are all examples of the demand for studies based on real-world studies and trials.

RegenMed Study Solutions

RegenMed’s platforms and processes accommodate the most complex of regulatory submission study requirements.   They are also flexible enough to support a busy sole practitioner in designing and conducting a modest private study.  Components include:

  • Clinical and scientific support in study design.
  • Customizable electronic case report forms, available in any language.
  • Automatic coordination of co-investigators and clinical team members.
  • Excellent patient engagement from initial enrollment through long-term outcomes follow-up.
  • Robust report generation.
  • Choose from dozens of standards of outcomes measures, or create your own.
  • Integration across the pre-, peri- and post-clinical phases of a study.  
  • Flexible consent form design, delivery, execution and maintenance.
  • Device agnostic (mobile and desktop), HIPAA/GDPR compliant.
  • Results available 24/7/365.
  • Download all data any time.
  • Ongoing technical, clinical and scientific support.
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