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Phase I

Research center for phase I Clinical Trial is an important part of Venturepharm CRO Service Group. The Center has over 10 years experience in clinical research and as the largest phase I CRO in china. We provide our clients with access to the vast populations, excellent turnaround times and experienced project management service. Data generated by our centers are directly acceptable to the SFDA.

Strategic alliances with 200+ Top Hospitals, covering 20+ provinces.

We have accomplished nearly 200 projects, 98% were approved by SFDA. 

 

  Analytical Method Database

 

We have established database of in vivo drug analysis methods, can meet different clients requirements.

 Dosage forms: tablet, capsule, particle, dispersible tablet, injection, sustained-release preparations, etc.

Analysis method: About 100 in vivo analysis methods with high sensitivity, good precision reproducibility and stability has been established, Including HPLC-UV, HPLC-FLU, HPLC-MS, GC, GC-MS, etc.

 

Our Services

 

Center offers comprehensive Phase I clinical trial and Bioequivalence (BE) project management. Protocol development

u Clinical PK program development

u Generic drug development

u ANDA bioequivalence (BE) project management

u Design and analysis of PK studies, with emphasis on in vivo/in vitro correlations    

u PK training for clinical project teams and specialized training for CRAs

Ø       Clinical conduct

u       Pharmacokinetics

u       Bioequivalence (BE)

u       Tolerance trial  

u       Drug metabolism

u       Drug–drug interactions

u       Drug–food interactions

u       Pharmacodynamics

u       Special populations

Ø      Volunteer recruitment

Ø       Monitoring

u       Site Monitoring

u       AE review/reporting

u       Quality assurance

u       Quality control

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