Clinical Pharmacology

Mosim has the largest clinical pharmacology team in China

Study Design & Data Analysis for Clinical Pharmacology Studies

? Dose escalation (SAD / MAD)

? DDI (drug-drug interaction)

? Food effect

? Bioavailability / bioequivalence

? QTc/thorough QT (TQT)

? PK/PD (Pharmacokinetics/Pharmacodynamics)

? Mass balance

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Biostatistics

Biostatistics for more efficient clinical trials

Complete Range of Advanced Biostatistics Services

? Study design

? Choice of endpoints

? Statistical analysis plan

? Statistical analysis

? Sample size calculation

? CDISC Standards: mapping SDTM into ADaM

? Data Monitoring Committees (DMCs) and interim analyses

? Production of statistical report/clinical study report

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Data Management (DM)

Mosim is certified for EDCs including Rave and Oracle Clinical RDC

Comprehensive data management services

? Data management plan (DMP)

? Database design and development

? Data entry

? Data review & query management

? External data transfer & reconciliation

? SAE reconciliation

? Dictionary coding (MedDRA & WHO Drug)

? Database lock

? Study archive

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Modeling & Simulation

Model-Informed Drug Development (MIDD)

Services Offered

? Noncompartmental analysis (NCA)

? PK/PD modeling and simulation

? Data entry

? Data review & query management

? PopPK(PD) analysis

? Physiologically based pharmacokinetic (PBPK) modeling and simulation

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Clinical Operation

Experienced project managers and well-trained CRAs

Services Offered

? Budget management for clinical trials

? Site selection and initiation

? Site monitoring and training

? Source data verification

? Managing timelines and deliverables for clinical trials

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Medical Writing

Focus on quality and delivery

Services offered

? Clinical development plan

? Clinical trial protocols

? Investigator brochures

? Informed consent forms (ICFs)

? Clinical study reports

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