1.    Project management and monitoring.
Based on client requests and research protocols, service is available throughout the whole course of clinical research projects.

Preliminary phase: design and modification of research implementation plans, operations manuals and other documents; formulation of project budgets and management plans; selection of sites and suppliers; ethics submission and contract signing.

Execution phase: construction of research network and management framework; coordination of responsibilities to expedite the project; undertaking of project training and initiation meeting; monitoring (monitoring plan, on-site and off-site monitoring, monitoring report, and follow-up of rectification); management of scheduling, fund and documentation; specimen transfer; risk surveillance and identification; and risk response that safeguards progress and quality of research.

Closure phase: data cleaning and database locking; site closure; project summary and report.

2.    Project audit
Project audit is an independent systematic review of operations, activities, and documents in clinical research to confirm that research protocol, standard operating procedure (SOP), Good Clinical Practice (GCP), and regulatory requirements have been upheld. It also includes assessments of human subjects protections, research quality and research progress by a specialized third party so as to prevent and control risks associated with the research.

    Targets of project audit include:
­    Quality assurance system (SOP and other rules and regulations);

Organizational structure and research facilities (organizational structure at the sites, responsibilities and mandates of the PI, qualification, training and duty fulfilment of the research team, and compliance of the research protocol in terms of equipment and facility);

Research execution by all the parties and implementation of quality assurance measures (compliance to the protocol, its modification and the SOP, management of drugs and devices, management and documentation of biospecimens, and drafting and implementation of monitoring plans);

Quality of the trial data and consistence of the original records to the protocol (attributability, authenticity and completeness of the data, compliance to inclusion and exclusion criteria, protocol compliance in terms of subject visit, consistence between original records and case report forms, and documentation of endpoint events and early withdrawal);

Human subjects protections (informed consent form, process, existence and format of signature, compliance to ethical requirements and GCP in confidentiality of the subjects’ private info, and timely and adequate communication between sites and the IRB, such as timely submission for continuing review and reporting of protocol deviation and serious adverse events); and

Documentation (existence of research files, soundness of records, and compliance in file saving measures).