Non Blind Monitoring

Working together to promote the clinical research and development process of innovative drugs and devices

Non Blind Monitoring

With the vigorous development of domestic and foreign pharmaceutical research and development companies, more and more innovative drugs and biologics are entering the clinical trial stage, which also brings new challenges to our trial design and execution: the implementation and management of blinding is one of them. Due to the special characteristics of the appearance, packaging, or configuration of the reference product, often the sponsor cannot provide completely consistent simulated products. In order to ensure the implementation of double-blind trial design, we can provide independent non blind management and monitoring services. Unlike the blind CRA responsible for verifying the work of blind researchers (those in charge of trial evaluation and subject management), our non blind CRA will be responsible for verifying the maintenance of trial blinding and the management of trial products.

服务范围

Service scope

● Provide blind management plan

● Non blind project management: blind management of clinical operations, management of trial and non trial products, communication and management with suppliers, etc

● Preparation before startup

● Initiation training: Blind state maintenance and training for non blind researchers

● Blind management: Development and update of blind management plan

● Non blind monitoring: blind state maintenance verification, verification of experimental product management, etc

Project Experience

The non blind monitoring of clinical trials of GCP ClinPlus chemical drugs and biological products involves multiple fields such as oncology, hematology, dermatology, respiratory, ophthalmology, etc