Clinical Trial Characteristics of CNS:
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 scalesand requirements related to thescale scoring are relatively high. So, to reduce the subjective scoring bias, it is necessary to ensure a well-established training program and process management.
Advantages of Tigermed:
Based on the characteristics of each of our clients’ projects, we carefully collect andanalyze allrelated information and, based on this, we formulatea 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 disease indication and medication, there is 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 ofour clients.
Our clinical trial experience includes but is not limited to the following CNS indications:
? Alzheimer's disease/senile dementia/antidepressant for healthy people
? Tic disorder
? Senile dementia
The CNS team is managed by 1 project director and 1 project manager, and 2 project supervisors that have an average working experience of 8 years.