Weekly internal study meetings – we a checking sites` metrics: enrollment status, query status, action items status, PD status – we excluding the most common reason of sites ineffectiveness – Gaps in an enrollment, overdue queries and action items, lack of a protocol compliance.

CRAs calling to the sites once per week or twice per months – it depends on patients` enrollment status, patients` visits frequency, general situation at the site – for continually sites control.

A project team sends the trials status reports biweekly to a Client.

Co-monitoring visits – measure provides comprehensive control of study compliance.

Learning Management System provides sites obligatory trainings supervising coverage.

Risk management assessment – risk-based approach allows to concentrate the attention on the study key risk indicators from the beginning.

Project management begins early, as soon as a Request for Proposal (RFP) for a new study is received. The Head of Clinical and Regulatory Operations identifies a suitable Project Manager based on their experience and key competencies.

During the RFP process, the Project Manager plays an active role in:
Assessing clinical study feasibility
Reviewing clinical trial documents
Pre-planning the study
Selecting preliminary sites
Preparing the study budget
Conducting a preliminary risk assessment and developing a mitigation plan
The outcome of this work is a proposal for conducting the study, which is submitted to the Sponsor for review and consideration.

Project management throughout the study follows a Project Management Plan that outlines all relevant information about the project, including the parties involved, components of the Quality Management System, milestones, risks, and other critical aspects.

During the study, the Project Manager:

Acts as the primary contact for the study Sponsor
Coordinates the project team and service providers
Develops study guidelines and tracking tools
Manages the regulatory submission process
Trains the project team
Monitors the achievement of project milestones
Oversees the project budget
Provides progress reports to the Sponsor
Regularly evaluates risks and implements corrective actions

The project concludes with the delivery of the Trial Master File to the Sponsor and the collection of a final Satisfaction Questionnaire assessing our performance on the project.