RBM

Clinical Risk Based Monitoring

With the release of the guidance document by FDA and the reflection paper by EMA, the biopharmaceuticals, medical device companies and CRO are actively embarking on this paradigm shift in clinical research to reap the benefits of Risk-Based Monitoring (RBM). MakroCare, a thought leader in RBM, offers a complete RBM solution by combing its process expertise and proprietary cutting edge technology. MakroCare offers consulting/advisory support for the implementation of RBM process, trained resources like risk manager, central monitor and also technology TULA, as a complete risk management platform through DDi which specializes in innovative technologies in clinical and regulatory space.

MakroCare’s RBM Services: Key Features

  • Highly experienced RBM advisory team for handholding throughout RBM Implementation to align new processes by mapping the existing structure
  • Developing, standardizing QbD, risk identification, assessment and centralized monitoring processes
  • Documentation, SOPs , reporting templates development for translating RBM perspective into actual practice and ensure regulatory compliance
  • Bringing resource alignment, role development/training – Central Monitor, Risk Manager
  • Support for necessary technology input or using sponsor in-house technology to build smooth RBM workflows and validation
  • Offers key resources like therapeutically aligned, trained central monitor with flexible business model as FTE, FFS or unit based costing

Technology: TULA – A Complete Risk Management Platform

TULA is a sophisticated Risk Management & Compliance tool designed to meet the varied mitigating aspects and monitoring needs of clinical development projects/programs. It aids conversion of risks into opportunity for improvement by consolidating risks across the entire study or program to achieve the regulatory, strategic and operational objectives.

TULA-Key Features

MakroCare’s RBM Solution: Value Proposition

  • A strong advisory support to provide clarity in translating RBM perspective into real practice and ensuring seamless change management
  • Brings the sense of simplicity in RBM implementation and take away the “perceived “ complexity
  • Improves quality, compliance and efficiencies in overall clinical trial management and demonstrating using right metrics tracking
  • Supports development of expertise at sponsor level to extend RBM to other studies/programs
  • End to end technology TULA for making RBM full-proof , efficient and also enabling better, timely decisions related to study management
  • Achieves high cost benefits and also ensures ROI on risk based approach

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