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Import Clinical research 

Scope of business 

●New drug clinical pharmacology,toxicology test and NDA application format edition;

●New drug pharmacokinetic research;

●Pharmaceutical preparations bioequivalence test;

●GlobalⅠ, Ⅱ, Ⅲ, Ⅳ phase of clinical trial of New drug development;


Introduction:

 Clinical Clinical research business unit held by Leadingpharm Group is composed of clinical operation dept., quality division, medical team, DM team & biostatistics team

       Over the past one decade, we have established good cooperative relations with number of research institutes, pharmaceutical companies, Medical Institutions as well as manufactuer experts and academics. Our Professional clinical research covering ares of cardiovascular division, respiratory, digestive, endocrine, urinary, gynecological, orthopedic, facial features, oncology, pediatric and other therapeutics. After years of effort, we had finished around 106 cases of Ⅰ、Ⅱ、Ⅲ and post market investigation trials, 36 cases of Bioequivalence clinical  test as well as 12 Third Party project. Since its founding. Thus bulilt good collarboration relationship with more than 200 domestic clinical institutions and agencies.。-新澳门30999com



Department Introduction

pharmacology and toxicology department:

The main business:

new drug pharmacology, toxicology literature retrieval and translation; New drug pharmacology, toxicology declaration data edition; New drug pharmacology, toxicology test; Preclinical drug metabolism and pharmacokinetic experiment.

competitive advantage:

header of the department has many years of practical work experience; Besides the test base in domestic, the regular project quote of our company is lower and respnsiable; We built long-term cooperation with well-known experts in the manufactory industry, therefore we can accurately grasp the complicated project design and implementation; Professional performance in compounds ADME research experience; Our management team also has accumulated rich experience in metabolism and pharmacokinetics of chiral drugs stereoselectivity research.




Clinical pharmacology department:

The main business: 

new drug tolerance test; Pharmacokinetic experiment; The human bioequivalence test; Drug analysis method establishment in vivo and authentication; The drug clinical trial institution in charge of the NDA preclinical application and construction; GCP training.

Competitive advantage: header of the department has many years of construction and management of the drug clinical trial institution work experience; Bulit solid relationship with a number of drug clinical trial institutions; Engaged in a variety of drug tolerance test, has accumulated experience in the design of experiments and cohesion with phaseⅡ clinical trials; To master a variety of drugs analytical determination method and key technology in vivo; Accumulated a variety of human drug pharmacokinetics and bioequivalence test problems processing experience. 


          

Clinic trial department:

         The main business: 

         We undertake new drug I,Ⅱ, Ⅲ, Ⅳ phase clinical trial; Medical device clinical trials and clinical validation; Drug clinical trial design; Drug clinical trial report audition;

Competitive advantage: 

         All the research personnel involved in GCP training; Header of the department has many years of clinical practice, drug clinical trial operation and management experience; The project manager has good professional background and long-term practical experience; To organize and coordinate a variety of drugs (including high difficulty varieties) clinical trials; Have good relations of cooperation with a number of drug clinical trial institutions; Deeply understanding in the perspective of the sponsor project; Actively solve the difficult or unusual events based on the research and clinical background and be able to get the support from the relevant units and persons.


         

 Data management and statistics department:

         The main business:

         Participating in the design of experiment; Blind Design experiment, packaging, grouping of pharmaceuticals, The process of making the statistical analysis plan; Clinical trials auditing; Supervision and control of Clinical trials quality. 

         Technology advantage:

         Participate in difficult or unconventional testing scheme design, provide constructive opinions; And the double-blind, double simulation into a complex positive controlled clinical trial in use of packaging design and group design; Clinical trials have perfect quality supervision and SOP control.



         

GCP auditing department:

        The main business:

 clinical trials on-site inspection, which means the inspection test center, involved in stage I to IV phase clinical test (drugs, medical devices, etc.); Auditing of Pharmaceutical companies or drug clinical trial institution of clinical trial management quality system;

        Competitive advantage:

        Auditing of Clinical trials research the central file (TMF) of auditing; The test data and statistical management;

        Auditing of Third party service provider with clinical trials (including contract research organization, logistics providers, IVRS/IWRS, etc.);

        Auditing before the drug administration authorities official check.



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Contact us

Address
Beijing City, Haidian District Yihai Qinghua East Road No. 16 building room 1403

Telephone
+0086 18611629129

Mailbox
zhangxu@leadingpharm.com

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