Founded in 1995, BEIJING JOINN PHARMACEUTICAL CENTER (Abbreviated as JOINN) is the first private Contract Research Organization (CRO) engaged in both pre-clinical and clinical services.
JOINN provides a series of services that include pre-clinical studies, clinical trials, and new drug registration. After more than ten years of hard work, JOINN has obtained extensive experience in pre-clinical studies and clinical studies, especially in safety evaluation of investigational new drug, such as animal toxicities.
JOINN built a state-of-art research facility in Beijing Economic and Technological Development Area in 2004. It has 2500 m2 of animal care facilities and 1500 m2 of research laboratories. A GLP certificate has been issued to our center by SFDA in April 2005. JOINN is striving to meet the international standard, and is committed to provide our clients with quality, cost-effective, professional and innovative service.
JOINN has established a strong, dedicated Quality Assurance Department backed by professionals from different disciplines.
Quality assurance team functions in the areas of
· Implementation of Quality Systems in line with GLP & GCP
· Internal audits
· Internal Quality checks
· Participation in Proficiency testing
· Redressal of customer complaints and feedback
· Training needs of Scientific Personnel
Standard Operating Procedures (SOPs)
JOINN has developed hundreds of SOPs to meet the Quality System requirements. Each SOP deals with the rationale of the study, test system, protocol, techniques, evaluation of the findings and conclusions.
The SOPs find their application in the following:
· Actualization of the experimentation
· Technology of the experimentation
· Use of apparatus
· Audit of QAU
· Administration of animal care facility
Former Director of Chinese Pharmacologic Soiety, Director, Toxicology Scientific Committee of Chinese Pharmacology
MD, MBA , Chairman & Managing Director
MD, Managing Director
MD, vice-director Technical
Director of the Pathology Division
MD, Director of the Pathology Division
Achievements in 1995-2006
Achievements in 1995-2006
JOINN evaluated 165 new drugs in the past decade. It included bio-pharmaceuticals, chemical drugs and Chinese medicine. The indications of these drugs are anti-tumour, anti-voris, immune-modulator, diabetes, hematological diseases and so on. The pre-clinical studies of the first marketed gene-therapeutic drug in the world were conducted at JOINN. We also have conducted more than 650 pre-clinical studies, 129 of which are chronicle toxicity studies. We have used thousands of rodents, beagle dogs, and monkeys.
JOINN started the first clinical trial of NGF in 1997. Since then we completed 36 clinical trials (phaseI-IV)
All the final reports of our studies were approved by SFDA and some were reviewed by US FDA. We have around 100 national and international clients.
‚óŹPreliminary evaluation of pharmacology, pharmacokinetics and toxicity for a candidate
3. Safety Pharmacology
‚óŹCentral nervous system
4. General Toxicity
‚óŹAcute toxicity studies
‚óŹChronicle toxicity studies
‚óŹLocal toxicity test
6„ÄĀPharmacokinetics and Toxicokinetics
‚óŹInvestigators (PT) Selection
‚óŹInvestigator's Brochure Preparation
‚óŹTrial Organization and Management
‚óŹTrial Monitoring and auditing
‚óŹSerious Adverse Event (SAE) Report and Evaluation
‚óŹData Collection and Analysis
‚óŹClinical Meeting Organization and Execution„ÄÄ
‚óŹInvestigational New Drug (IND) registration
‚óŹDiagnostic Regents and Devices Registration
‚óŹMedical Devices Registration
‚óŹHealthy food Registration