Services

Each site and situation is different, but as a starting point, we are able to assist with the following:

For a brand-new research site looking to embark onto clinical research with robust and efficient processes

✓ Compiling site information

✓ Assisting with feasibility discussions

✓ Organizing regulatory documents

✓ Training staff on best practices

✓ Implementing organization systems

✓ Shadowing patient visits

✓ Offering support with data entry and documentation

✓ Putting best practices in place

✓ Ensuring site is inspection-ready

For an established research site that wishes to undertake more complex studies

✓ Site assessment

✓ Patient population assessment

✓ Study feasibility discussions

✓ Medical equipment sourcing

✓ Vendor selection and service negotiations

✓ Study staff training

✓ Selecting new staff – if needed

✓ Prepare for the initiation visit

✓ Prepare for site activation

✓ Support with processes as outlined in the Start Up plan

For any site requiring support ahead of an inspection, or looking to streamline processes in order to be inspection-ready

Assess and rectify any issues with:

✓ Study data and documentation

✓ Central documents

✓ Study personnel credentials and training certifications

✓ SOP and GCP compliance

✓ Equipment calibration records

✓ Vendor agreements

✓ Cost tracking

Other assessments as required