Mosim was founded in 2015 in Zhang-Jiang Pharm Valley, Shanghai, China. It was the 1st CRO privides clinical pharmacology services in China
Our services expanded into biostatistics and data management.
By expanding its clinical operation team, with a focus on clinical pharmacology studies, Mosim became a full service clinical CRO!
Mosim Co., Ltd has been acquired by Tigermed, a leading clinical Contract Research Organization (CRO).
CEO
VP, Clinical Pharmacology
VP, Business Development
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
? Special populations (renal/hepatic impairment)
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
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
Model-Informed Drug Development (MIDD)
Services Offered
? Noncompartmental analysis (NCA)
? PK/PD modeling and simulation
? NONMEM data prepration
? Data review & query management
? PopPK(PD) analysis
? Physiologically based pharmacokinetic (PBPK) modeling and simulation
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
Focus on quality and delivery
Services offered
? Clinical development plan
? Clinical trial protocols
? Investigator brochures
? Informed consent forms (ICFs)
? Clinical study reports