Medical Writing
Provide professional writing and review services for clinical trial related documents according to characteristics of product, including: trial protocol, case report form, informed consent, study medical record, investigator’s brochure, clinical study report, etc.
Clinical monitoring
Preparation for site initiation (select site, organize investigator conference, apply for ethical review, apply for the review by China Human Genetic Resources Management Office, negotiate about and sign the contract with site, etc.)
Site Initiation and Training
Clinical Trial Monitoring
Product management
Site Close
Clinical trial quality control
Project management
Based on a comprehensive project management standard operating procedure (SOP), clinical trial management system (CTMS), tools and training system, and a customer-centric service idea, the GCP project manager, as projects leader, will provide you with a one-stop solution for the overall management of clinical trials, including the development of project scope, schedule, quality, fund, risk, team, communication and other related management plans, tracking and reporting project progress, identifying project risks, solving project problems, and ensuring that deliverables meet expectations.
Our advantage:
Experienced management team
Our project management team consists of a group of experienced clinical trial managers from the industry's top medical device manufacturers and CRO companies. We can undertake medical device registration and post-marketing clinical trials, with extensive project management experience and expert resources in various therapeutic areas such as ophthalmology, cardiothoracic surgery, vascular surgery, ICU, nephrology, blood purification center, otolaryngology, dentistry, gynecology, gastroenterology, neurosurgery, orthopedics, anesthesiology, nursing.
Advanced management concepts and standardized, systematic management tools
All of our project managers receive professional project management training, including the US Project Management Professional (PMP) series courses, DIA project management training, etc., to ensure our advanced and professional project management theory and methods. In addition, the application of project management SOP and templates, CTMS project management systems, standardized processes and tools, etc., enables our project management work to be standardized, professional and systematic.
Customer-centric efficient execution
We have been adhering to the customer-centric service idea, based on the professional knowledge, actively identify, quickly respond to customer needs, proactively solve project problems, and maintain healthy and efficient communication and cooperation models with stakeholders. In previous cooperation, several project managers have received verbal or written recognition and acknowledgement from global and local sponsors.
Our project management services:
Provide customers with the overall strategies and solutions for project management based on project characteristics and customer appeals
Develop an overall project management plan including project team, schedule, quality, fund, risk, communication and management, etc.
Develop a feasible enrollment plan and strategy for projects
Develop a project progress plan and continuously monitor progress risks and resolve progress issues during the progress of projects
Refine projects quality management plan to ensure that projects quality meets the requirements of GCP and related laws and regulations.
Refine project risk management plans, including risk identification, prevention and coping strategies, ongoing risk monitoring and risk register updates
Refine project communication plan based on contract, project characteristics and customer needs
Develop a management plan for project expense and track expense usage
Data Management and Statistical Analysis
Data management: Data management services for EDC projects and paper projects in each therapeutic area
Biostatistics: Provides comprehensive biostatistical services of clinical trial design, analysis and reporting
Statistical programming: Provides comprehensive statistical programming related services, especially the implementation and electronic submission of CDISC
On-site Audit
Cooperating and coping inspection of NMPA
Root cause analysis
CAPA development / training / tracking
> 100 audits
Project audit and QMS audit
25 inspections
25 projects passed NMPA inspections
100% of projects passed CFDI inspections