Post Approval

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.

Post Approval Studies RWE & PAS Centralized Solution

  • Non-Traditional, smart approach with centralised 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.

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