Clinical Trial Project Management and Quality Supervision

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Service Introduction

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.

Service Description

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

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