- Bio-Statistics
- Clinical Operations
- Data Management
- Medical Affairs
- Pharmacovigilance
- Phase I & Pharmacokinetics
- Phase II-III
- Real-World Studies
- Regulatory Strategy
*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