HONOREM

SERVICES

*Our Services

Honorem provides high quality, versatile and custom tailored support in the complex
processes of bringing a product to market.

  • Bio-Statistics•Statistical Study Design
    •Sample Size & Power Calculation
    •Statistical Analysis Planning
    •Randomization Schedules
    •Web Randomization (IWRS by System engineer)
    •Statistical Analysis and Programming
    •Table/Figure/Listing
    > Read More
  • Clinical Operations•Project Management
    •IRB Submission
    •Monitoring
    > Read More
  • Data Management•Data Management service
    •Medical Monitoring
    •eCRF System Development
       - Medidata Rave
       - CRS Cube
       - ALLOGS
    •AE Data Set Development
    > Read More
  • Medical Affairs•Medical Writing
    •Regulatory Writing
    •Scientific Writing
    •KOL/HCP Mapping
    •Medical Support for Pricing and Reimbursement
    •Publications and Scientific Journal
    > Read More
  • Pharmacovigilance•AE Follow up
    •AE Reporting
    •AE Assessment
    •CIOMS Form Writing
    •Risk Management Plan Development
    •Medical Review
    •Safety Monitoring
    •Trending Assessment
    > Read More
  • Phase I & PharmacokineticsHonorem can assist our partners in the design and delivery of the early-phase clinical development.
    We understand the challenges of rapidly shifting factors, involving regulatory requirements, study design strategies and project optimization.
    > Read More
  • Phase II - IIIHonorem understands that the journey through Phase II-IV trials need to be streamlined and efficient.
    We can help reduce delay, error and costs.
    > Read More
  • Real World Studies•Post marketing surveillance (PMS)
    •Observational Study
    •Non-Interventional Study
    •Registry
    > Read More
  • Regulatory Strategy•Regulatory and Market Access Strategies
    •NDA Package Preparation
    •Regulatory Dossier Writing
    •Health Authority Engagement Support
    > Read More