Additional Services (MicroConstants China)
In 2007, Dr. Gilbert Lam, the founder of MicroConstants, Inc., and Dr. Q. David Yang, Executive Director of Beijing Ascend Tech Corp., jointly established MicroConstants China Inc., a Contract Research Organization (CRO) in Beijing, China, to meet the growing demand of pharmaceutical development outsourced to Asia. MicroConstants China’s bioanalytical laboratory in Beijing has adopted the quality system of MicroConstants, Inc. of San Diego and is in compliance with USFDA, OECD, and MHLW Good Laboratory Practice (GLP) guidelines.
Below are the drug development support services that MicroConstants China provides. For more information about any of these services, or to request a quote, please contact us.
Phase I Clinical Trials in China
- Dose escalating safety studies
- Pharmacokinetics studies
- Bioequivalence studies
- Bioavailability studies
- Drug-drug interaction studies
- Food effect studies
- Protocol/CRF development
- Clinical site qualification/audit
- Clinical trial management/monitoring
- Data management/biostatistics
- English/Chinese reports
Clinical Sample Bioanalysis
- Method development
- Method validation
- Sample bioanalysis
Preclinical Pharmacokinetics Studies
- Rodents
- Dogs
- Non-human primates (NHP)
Consulting for Global Product Development
- Strategic planning for IND filing in China and the United States
- Business development in China
- Out-licensing service consulting
- Quality system auditing
Drug Development Program Management
MicroConstants China will manage your toxicology studies and Phase I clinical trials, including:
- Identifying study site(s)
- Designing, developing, and optimizing the study protocol
- Coordinating drug supply and test article shipments
- Managing all client communications
- Monitoring and communicating study progress
- Writing and reviewing reports
- Preparing and submitting USFDA and SFDA packages
Quality Assurance System Development and Training
- Conduct comprehensive regulatory compliance assessments
- Establish and implement Quality Assurance (QA) systems
- Conduct QA auditor training programs
- Develop and implement Standard Operating Procedures (SOPs)
- Document management system development, implementation, and training
- Laboratory information management system (LIMS) development, implementation, and training
