Evidence Generation

YOLARX provides expertise and conducts research of the highest methodological standards.

The world of evidence is changing, with regulators and payers increasingly seeking the demonstration of value beyond clinical outcomes.

YOLARX will guide you through the generation of scientific and valid evidence on drug benefit-risk in the real-world and assist you in each of the steps:

  • Evidence Synthesis & Knowledge Gaps
    • Systematic literature review
    • Meta-analysis
    • Patient journeys
    • Database Mapping
  • Study Design & Development
    • Protocol & Case report forms
    • Statistical analysis plan
    • Study materials and validated scales (licenses, translations)
    • Investigator meeting
    • Feasibility assessment and pilot studies
  • Study Set-Up
    • Ethics committee submissions
    • Regulatory documents preparation and collection
    • Sampling of representative sites in accordance with sampling strategy
    • Study sites recruitment
    • Investigator agreements
    • Training
  • Study Conduct
    • Study management and site support
    • Data management: database design, data export and archiving, quality control
    • Data review and monitoring
    • Pharmacovigilance
  • Evidence Development
    • Data access (claims and EMRs)
    • Data analysis
    • Report, abstracts and manuscripts
  • Integrated Quality Assurance Process
  • Medical Writing

 

Already have a clinical research organization (CRO) who is a preferred provider for multi-national studies?  No problem, we can develop the global protocol and country-specific adaptations; write the statistical analysis plan (SAP); obtain the study database and analyze the data in accordance with the SAP. We have done this type of collaboration in several countries.