Clinical Trial Service
- Categories:Clinical Trials
- Time of issue:2021-03-25 14:56:06
Our service covers phase I to phase IV clinical study of drugs, medical devices and IVDs. Our technicians have many years of experience in international multi-center clinical trial registration as well as rich research experience in over 20 fields including respiration, digestion, oncology, internal secretion, neurology, nutriology etc. We have an efficient and professional CRA team distributed in over 20 provinces and municipalities in China to provide convenient and high-quality project management and monitoring service for you.
➣ Service Scope:
a.Project management: CRCS is capable of formulating and implementing project management plan, risk management plan, and budget management plan to assist clients to complete site screening, investigator selection and patient enrollment at the fastest pace.
b.Clinical monitoring: during clinical monitoring service, CRCS strictly follows our client's SOPs or our own SOPs in all works related to the monitoring, such as verification of case report form and original data and resolution of data query. And we archive data in a reasonably and efficient way.
c.Clinical trial audit: we provide clinical trial audit service including drug, medical device and IVD clinical trial audit, and we can carry out audit on study site as well as sponsor's research documents. All our auditors have more than 10 years of experience in clinical trial. Since CRCS was founded, we have carried out clinical audit for projects including international multi-center clinical trial and registered clinical trial. We have already accumulated extensive experience in third-party audit for self-verification projects regarding drugs, medical devices and IVDS. The standards we adopt for audit include ICH GCP, NMPA GCP, and relevant laws and regulations of China and our clients are mostly well-known global and domestic pharmaceutical enterprises.
d.Medical writting: our medical writing team can provide professional medical writing service, which includes phase I to phase IV and BE study protocol, medical records, case report form, informed consent form, investing
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The company specializes in medical device registration, in vitro diagnostic reagents registration, cosmetics agent service company, committed to the NMPA, CE regulation research and product registration and certification service has been more than 17 years.