Staffed with experienced professionals in the field of clinical trials management and supported by senior consultant who has solid medical background and expert tank focusing on different research area, we can provide total solution service during the process of clinical trials and benefit all patients. Our services also include GCP authorization and biostatistics.

Clinical Research Service

Pharma-engine offers a wide range of services to all organizations conducting clinical trials. Our Medical experts and consultants are committed to the highest quality standards. And together with our well trained CRA staff with SOP, we ensure the highest standard of clinical trial monitoring within budget, on time, every time.

As we customize our approach to the needs of each client, we offer the following services separately or in any combination required.

Our services are as follows:

• Protocol Design, CRF Design
• Investigational site Assessment & Validation
• Subjects recruitmen
• Sites Monitoring Service
• Medical Report Writing (English/Chinese)
• AE/SAE Reporting
• Data Management
• Statistical Analyses

Clinical Research Activities Flow-chart

• Relevant clinical information collection
• Site selection and Investigator communication
• Design investigator brochure
• Investigator selection
• Finalize protocol
• Communicate with statistician to determine the statistical protocol and masking.
• Trial drug preparation
• Monitor activities planning
• Investigational brochure, CRF, ICF, protocol preparation.
• EC approval
• Organizing investigational meeting
• Dossier preparation and putting on code in SFDA
• Co-investigational site personnel training, trial initiation.
• Site monitoring and QC conform to the plan
• Organizing interim meeting
• AE/SAE report
• Data management
• Statistic analysis
• Co-investigational site form
• Final investigational meeting
• Write clinical report
• clinical application dossier preparation
• Residuary trial drug and goods reclaiming and disposure
• Site closure