With A Proven Quality By Design Framework

Applying our Quality By Design framework in clinical trials saves time, money, and resources. These are crucial, precious, and practical factors to consider before starting a study.

An ingrained Quality By Design framework achieves this by:

  • checkmarkFacilitating compliance to ICH E6 (R2), ICH E8, FDA BIMO Regulatory Guidance
  • checkmarkReducing protocol amendments based on past learnings and the design
  • checkmarkPerforming faster submission and findings-free inspection
  • checkmarkDelivering consistent and efficient delivery of reliable data
  • checkmarkEnsuring patient safety
  • checkmarkSaving effort (for example, identifying low-performing sites and replacing them with high-performing ones saves monitoring efforts)
  • checkmarkCarrying forward key learnings to benefit future trials

REQUEST WHITEPAPER