Clinical Trial Project Management and Quality Supervision
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The company has an excellent clinical operation team that provides professional and reliable clinical project management coordination and quality services for sponsors to ensure that clinical trials comply with the Quality Management Standards for Pharmaceutical Clinical Trial, clinical trial programs, and SOP requirements.
Communication between all parties in the project implementation and signing of contracts
Project implementation progress control, organization and coordination of all parties
Meeting organization (plan discussion meeting, project launch meeting, data review meeting, etc.)
Preparation of basic clinical trial documents (plan, case report form, informed consent form, etc.)
Research center qualification inspection: center qualification, equipment and staffing, SOP status, etc.
Researcher qualification inspection: educational background, work background, training experience, etc.
Project establishment and ethics submission, obtaining ethical approval documents
Audit plan writing
Launch meeting training
Subject protection inspection
Inspection of drug receipt, use, recall and others
Subject screening and inspection
Subject drug administration, treatment, visit and inspection
Data recording process inspection
Original medical record inspection
Data entry inspection
Inspection report writing
Tracking and solving inspection problems
Project data archiving
Checking and review of reports