Phase IV & NIS

Medical Writing

Develop plan strategies based on research objectives, including writing trial protocols, case report forms, informed consent forms, study medical records, investigator manuals, clinical research reports, etc.

Clinical monitoring

● Feasibility Study of the Project

● Rapid initiation of clinical trials (good hospital cooperation relationships and extensive distribution of offices, rapid support for research centers to monitor clinical research data in a timely manner, efficient operation of clinical trials; providing optimal management for the development of large sample and large-scale clinical trials.)

● Screening of research centers, organization of researcher conferences, ethical declaration, application for human resources and heritage management, negotiation and signing of research center contracts, etc

● Clinical trial monitoring

● Quality control of clinical trials

● The research center is closed

Project management

Based on a comprehensive project management standard operating procedure (SOP), clinical trial management system (CTMS), tools, and training system, and adhering to a customer-centric service philosophy, the GCP ClinPlus project manager, as the project leader, will provide you with a one-stop solution for overall clinical trial management, including developing project scope, schedule, quality, funding, risk, team, communication, and other related management plans, tracking and reporting project progress, identifying project risks, resolving project issues, and ensuring that deliverables meet expectations.

Our project management services

● Provide customers with overall project management strategies and solutions based on project characteristics and customer demands

● Develop an overall project management plan that includes project team, schedule, quality, cost, risk, communication management, etc

● Develop feasible project onboarding plans and strategies

● Develop a project schedule and continuously monitor progress risks and resolve schedule issues throughout the project progress process

Refine and develop a project quality management plan to ensure that project quality meets GCP and relevant regulatory requirements

● Refine and develop a project risk management plan that includes risk identification, prevention, and response strategies, conduct continuous risk monitoring, control, and update the risk register

● Develop a detailed project communication plan based on the contract, project characteristics, and customer needs

● Develop a project cost management plan and track the use of expenses

Pharmacovigilance

● Review SAE reports, archive signed scanned copies of SAE reports and fax receipts, regularly summarize and report to the sponsor (based on specific project requirements), and assist other departments in handling SAE related issues.

● Comprehensive and integrated pharmacovigilance services throughout the entire product lifecycle:

● Review the Chinese and English versions of SAE

● Archive signed SAE report and fax receipt

● Regularly summarize and report

● Assist in handling SAE related issues

Data Management and Statistical Analysis

● Data management: Provide data management services for EDC projects and paper projects in various treatment fields

● Biostatistics: Providing comprehensive biostatistics services for clinical trial design, analysis, and reporting

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

Research Center Inspection

● According to project requirements, conduct inspections on 20% to 50% of research centers during different project lifecycles

● Root cause analysis of the problem

● CAPA development/training/tracking

Our Advantages
Experienced management team
Experienced management team

Our project management team is composed of a group of experienced clinical trial managers from large pharmaceutical companies and CRO companies in the industry. They are capable of undertaking various types of drug clinical trials, including Phase I-IV drug clinical trials, bioequivalence trials (BE), pharmacokinetic trials (PK), and non interventional studies (NIS). They have rich project management experience and expert resources in multiple treatment fields such as cardiology, respiratory medicine, oncology, endocrinology, infectious diseases, ophthalmology, gastroenterology, rheumatology and immunology, hematology, dermatology, neurology, anesthesia, psychiatry, and burns.

Advanced management concepts and standardized, systematic management tools
Advanced management concepts and standardized, systematic management tools

Our project managers have received professional project management training, including American Project Management Professionals (PMP) series courses, DIA project management training, etc., which ensures our progressiveness and professionalism in project management theory and methods. In addition, the application of project management SOP and templates, CTMS project management system and standardized processes, tools, etc., enables our project management work to be standardized, specialized, and systematic.

Customer centered efficient execution
Customer centered efficient execution

We have always adhered to the customer-centric service philosophy, based on professionalism, actively identifying and responding to customer needs, actively solving project problems, and maintaining a healthy and efficient communication and cooperation model with stakeholders. In previous collaborations, multiple project managers have received verbal or written recognition and acknowledgements from both global and local sponsors.