Medical Writing

Provide professional writing and review services for clinical trial related documents, including: trial protocol, case report form, informed consent, study medical record, investigator’s brochure, clinical study report, etc.

Clinical Monitoring

Project feasibility investigation

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

Clinical Trial Quality Control

Site Close

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 advantages:

Veteran management team

Our project management team consists of a group of experienced clinical trial managers from the industry's top pharmaceutical companies and CRO companies. We can undertake various drug clinical trials, including phase I-IV drug clinical trials, bioequivalence (BE) testing, and pharmacokinetic (PK) and non-interventional study (NIS), with extensive management experience and expert resources in multiple therapeutic areas such as Cardiology, Respiratory, Oncology, Endocrinology, Infectious Diseases, Ophthalmology, Gastroenterology, Rheumatology, Hematology, Dermatology, Neurology, Anesthesiology, Psychiatry, Burns, etc.

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 advancement and professionalization in regard to 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 and quickly respond to customer needs, proproactively solve project problems, and maintain a healthy and efficient communication and cooperation mode with stakeholders. In previous cooperation, many project managers have received verbal or written recognition and acknowledgement from global and local sponsors.

Our project management services:

Provide customers 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

Formulate 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 the 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

Pharmacovigilance

Review the SAE report, archive the scanned version of the signed SAE report and fax scanned receipt, which are summarized and submitted to the sponsor (according to the specific requirements of projects) on a regular basis, assist other departments in handling SAE related issues.

All-around, integrated pharmacovigilance service throughout the whole lifecycle of products:

Review SAE in Chinese and English editions.

Archive signed SAE reports and fax scanned receipts

Summarize and report on a regular basis

Assist with SAE related issues

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 covering clinical trial design, analysis and reporting

Statistical programming: Provides comprehensive statistical programming related services, especially the implementation and electronic submission of CDISC

Study site audit

According to projects requirements, conduct audit on 50%---100% of the sites in different stages of project lifecycle

Cooperating and coping the audit of NMPA


Root cause analysis

CAPA development / training / tracking