Our Services

Clinical Pharmacology
Consulting

A team of experienced DABCP board-certified clinical pharmacologists

The American Board of Clinical Pharmacology (ABCP), and biomedical scientists provide consulting, document, and translation services for all stages of drug development for small or large pharmaceutical companies

• Professional English and Chinese translations for medical documents

• (including but not limited to study protocols, Investigator Brochures (IB), clinical study reports (CSR), Briefing Book, IND, NDA, drug labels)

Data Analytics

Document Preparation

Let us help you

• Clinical trial design and protocol development for various oncology indications

• Provide support for biomarker selection and validation

• Provide support and recommendations for clinical doses and dosing algorithms

• Provide support for marketing applications and prepare presentations for marketing

• Provide support for quantitative PK approaches to address questions arising during drug development and regulatory review

• Provide support to advisory boards, consultant meetings, and investigator meetings

• Provide non-compartmental and PK/PD analysis and report of clinical pharmacology studies

• Integrate pharmacokinetics, pharmacodynamics, biomarkers, patient characteristics, and disease states to optimize doses and dose regimens

• Provide documents including IND, EOP1, Investigator Brochures, NDA

• Respond to clinical pharmacology queries from regulatory agencies of the United States (FDA), China (CDE), Japan (PMDA), and Australia (TGA)

• Review and edit protocols, TFL, and CSR about food effect studies and mass balance studies

• Prepare scientific publications, including conference posters, abstracts, and manuscripts

Translation