Transfer of New Products
Noken, in strict accordance with relevant policies and regulations like GCP as well as operation specifications, provides the clinical test for domestic traditional Chinese medicine and western medicine, biological products and diagnostic reagents as well as the clinical verification services for imported drugs, biological products and diagnostic reagents, builds a green channel between the government, enterprises and clinical research units, and also can customize a personalized service scheme according to the customer requirements and carry out the all-the-way tracking or provide single special services which are as follows:
Preparations for test: preparing and formulating the clinical test scheme; preparing the Case Report Form (CRF); preparing the original documents; selecting the hospitals and doctors participating in the test; preparing the Informed Consent Form, participating in the Ethics Committee and obtaining the approval documents;
Designing and preparing the researchers’ meeting;
Preparing and organizing the researchers’ meeting;
Organizing and managing the testing process;
Monitoring the clinical research;
Dealing with the adverse events;
Writing the test conclusion report;
Phase I clinical test
Phase II clinical test
Phase III clinical test
Phase IV clinical test
Bioequivalence testing
I. Evaluating the clinical research scheme;
II. Selecting clinical research center;
III. Preparing the training documents;
IV. Recruiting researchers
V. Actively communicating and coordinating
VI. Preparing the clinical test data