Clinical Research Services
Clinical Pharmacology
The Department of Clinical Pharmacology brings together a team of master’s and doctoral graduates from top universities including Peking University and China Pharmaceutical University, providing full-cycle pharmacology support from project initiation to market launch. With in-depth expertise in oncology, cardiovascular diseases, and antiviral research, we excel in leveraging models such as PPK/PD, PBPK, and C-QT to guide R&D, facilitate the success of multiple clinical waivers, and empower the efficient development of drugs.
Clinical Pharmacology
INTRODUCTION
The Clinical Pharmacology Department comprises graduates from Peking University, China Pharmaceutical University, Xi'an Jiaotong University, etc., all holding master’s degrees or above with an average of 5+ years of experience. With on-site offices in Guangzhou, Beijing, Nanjing, etc., we flexibly allocate personnel to provide robust technical support.
Committed to end-to-end pharmaceutical clinical R&D services—covering project initiation evaluation, non-clinical data interpretation, and pre-marketing research—the department plays a pivotal connecting role in enhancing R&D efficiency. It boasts experience across oncology, cardiovascular diseases, liver diseases, antiviral therapies, endocrinology, weight management, etc., and multiple successful clinical trial waivers.
Additionally, the team has made initial progress in model-informed drug development (MIDD), successfully constructing PPK/PD, C-QT, PPK-BE, PBPK-PD models to assist sponsors in optimizing R&D strategies and decisions.
Committed to end-to-end pharmaceutical clinical R&D services—covering project initiation evaluation, non-clinical data interpretation, and pre-marketing research—the department plays a pivotal connecting role in enhancing R&D efficiency. It boasts experience across oncology, cardiovascular diseases, liver diseases, antiviral therapies, endocrinology, weight management, etc., and multiple successful clinical trial waivers.
Additionally, the team has made initial progress in model-informed drug development (MIDD), successfully constructing PPK/PD, C-QT, PPK-BE, PBPK-PD models to assist sponsors in optimizing R&D strategies and decisions.
OUR SCALE
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200+Engage in various projects
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50+Support project approvals
SERVICE CONTENT
Clinical Protocol Design and Writing
- On-schedule design and drafting of clinical trial protocols, including food effect (FE) studies, drug-drug interaction (DDI) studies, mass balance and biotransformation studies, trials in special populations (hepatic/renal impairment, adolescents), bioequivalence trials, and Phase 1b patient exploration, etc.
Early Strategy Optimization
- Services include FIH dose prediction and dose exploration plans, data borrowing strategies for clinical development of modified new drugs, ethnic difference analysis and bridging strategies, food effect prediction, human effective dose prediction, dose adjustment in special populations, preparation of priority review and approval materials, and (Pre)IND/(Pre)NDA document preparation, etc.
Quantitative Pharmacology Services
- Services cover PK/PD and TK/TD models, population PK/PD models, physiologically based pharmacokinetic models, drug absorption models, pharmacodynamic-disease progression models, exposure-response (E-R) relationship analysis, and quantitative pharmacology analysis for selecting RP2D, etc.