Post-Approval: Tech-driven Centralized Solution
Regulatory authorities require post–approval research to decide real world safety and the payers require validation of products’ real-world clinical value and cost effectiveness. RWE & Post Approval Studies are becoming increasingly important and necessary.
MakroCare understands strategic, operational objectives and budgetary constraints of post-approval studies and therefore offers non-traditional, innovative, Technology-Driven Centralized solution to design and execute these studies more cost effectively.
RWE & PAS Centralized Solution
- Non-Traditional, smart approach with centralized solution to keep costs significantly lower
- Fully integrated and validated technology for data capture from sites, data cleaning automation, analytics, and data quality risk management for these projects
- Full-service option utilizing our medical/clinical experts in RWE & PAS help in design & planning of these programs
- Centralized team members like PMs, CRAs, Central Monitors, central Data Scientists, and Medical/safety team drive the execution remotely
Value Proposition of our Unique Solution
- 20%-50% cost savings with our centralized solution over traditional approach
- Use of our smart technology to facilitate centralized model
- Get clean data on time. Finish faster
- Compliance maintained at all levels
MakroCare’s Post-Approval business unit focuses exclusively on Observational, Registry, P IV, PMS and RWE programs. This unit is led by teams who understand that post-approval research is different from R&D; programs and bring specific experience in these programs.