Open-label inspection

Release time:2018-07-14 Source of the article:Open-label inspection

With the vigorous development of domestic and foreign pharmaceutical research and development companies, increasingly more innovative chemicals and biological agents have begun to enter the clinical trial stage, which brings new challenges to our trial design and execution: one of which is the realization and management of the blind methods. Due to the particularity of the appearance,
packaging or configuration of control products, sponsors cannot provide a completely consistent dummy product in many cases. In order to ensure the realization of the double-blind trial design, we can provide independent open-label management and monitoring services. Unlike blind CRA, which is responsible for reviewing blind researchers (researchers responsible for trial evaluation and subject management), our open-label CRA will be responsible for blind state maintenance for the trail and the inspection of test product management.
Service Scope

Providing blind management solution

Open-label project management: blind management of clinical operations, test product and non-test product management, supplier communication and management, etc.
Preparation prior to initiation
Initiation training: blind maintenance and open-label researcher training
Blind management: development and update of blind management plan
Open-label monitoring: inspection of blind maintenance, test product management, etc.
Project experience
GCP’s open-label monitoring for clinical trials of chemicals and biological products involves multiple areas: departments of oncology, hematology, dermatology, respiratory, ophthalmology, etc.

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