Culture & Values
Subsidiaries & Joint Ventures
Diversity & Inclusion
Sustainability & ESG Report
Safety & Toxicology
Data Management and Statistical Analysis
Clinical Development Strategy
Site Management (SMO)
Medical Device / IVD
Multi-region Clinical Trial (MRCT)
Vaccine Clinical Trial
Functional Service Provider (FSP)
Central Nervous System
Key Challenges of CNS Clinical Research
Due to the special nature of CNS diseases and public recognition, protection of privacy can lead to difficulties in securing the informed consent and follow-up in this field.
Additionally, there is significant competition surrounding clinical development in this area with relatively few centers where clinical trials can be conducted. This means there is increased competition for enrollment which sometimes means longer waiting periods before trial initiation. And with low compliance and subject retention, follow-up is also challenging in CNS clinical development.
Besides this, most of the major evaluation indicators use scales and requirements related to the scale scoring are relatively high. So, to reduce the subjective scoring bias, it is necessary to ensure a well-established training program and process management.
Exceptional Expertise in Medical Science and Clinical Practice
Based on the characteristics of each of our clients’ projects, we carefully collect and analyze all related information and, based on this, we formulated science and risk-based plan in order to provide a strong guarantee to assist our clients in successful clinical development and shortening the time to market for their products.
For each CNS disease indication and medication, we have a standardized management process in place to ensure that the clinical study meets all ICH-GCP and China’s GCP requirements and that high-quality clinical study data can be obtained. This approach is how Tigermed has gained a proven track record is fully meeting and exceeding the expectations and the various requirements of our international and domestic life sciences clients.
Making use of a sound Quality Management System, the risk of scoring bias in scales is controlled and managed, the quality of protocol violations is controlled, and dedicated staff is exclusively responsible for data review work, to guarantee the quality of the collected data. This process also facilitates improves the auditing process, including self-inspection and verification at the end of trials, as to minimize the risk in the clinical development programs of our clients.
CNS Clinical Trials