Study Management

We specialise in comprehensive study management services, from facility inspections to protocol reviews and in-phase sponsor representative visits, ensuring regulatory compliance and study success throughout the entire lifecycle.

OUR STYLE

Study Management

At the VICH GCP Consultancy, we understand the importance of study oversight in ensuring our clients interests, enhancing quality whilst respecting the overall project timelines. We have extensive experience in managing VICH GCP pre-clinical, post-marketing and GLP compliant studies in the role of Sponsor Representative. Our services are designed to provide comprehensive support to the Sponsor throughout the study from conception to report.

Our services include: Facility Inspections, Protocol/Study Plan Review, In-Phase Sponsor Representative Visits, Final Study Report Review.

A brown and white calf is laying in the grass.

Facility Inspections

Facility Inspections, conduct thorough inspections of test facilities, test sites, study sites, laboratories, and animal facilities to ensure compliance with VICH GCP or GLP guidelines. Verify the suitability of the facilities, equipment, and personnel to perform the study, as well as the design for the planned collection and handling of study data.

Protocol/Study Plan Review

Protocol/Study Plan review, to identify potential areas of concern and provide feedback to the Sponsor. This helps ensure that the study is well-designed, scientifically sound, and compliant with regulatory requirements.

In-Phase Sponsor Representative Visits

In-Phase Sponsor Representative Visits during the study perform regular inspections of test facilities, test sites or animal facilities to review compliance with VICH GCP or GLP guidelines. Working closely with the Sponsor to ensure that their interests are being protected and that the study is progressing as planned. Review all study data and clinical study files for completeness, accuracy, and consistency. Perform data checks and verifications to ensure that the data are suitable for analysis and reporting.

Final Study Report Review

Final Study Report Review, to ensure that it is well-written, accurate, reflects the objectives of the study and is compliant with regulatory requirements. Perform a QC check on the report to ensure that it meets our high standards of quality.

CUSTOMISED SOLUTIONS

Tailored Documentation to Meet Your Specific Study Needs

Whilst some clients prefer The VICH GCP Consultancy to operate according to the Sponsor’s own SOPs, some clients require bespoke SOPs to be provided which document the work The VICH GCP Consultancy will undertake on their behalf.

Here is an example SOP which details the Sponsor Representative’s role on a pre-clinical or GLP study: