JSS Medical Services offers QA Services to facilitate study start up and execution either as stand alone services or as part of the study package including:
•Standard Operating Procedure (SOP) development
•Vendor or site auditing
•Good Clinical Practices (GCP) Training
Development of standard operating procedures in compliance with applicable regulations either as general descriptions of processes for all clinical trial activities or customized to specific study requirements.
Vendor auditing (i.e. laboratories) as part of the pre-qualification process or site auditing as part of the site selection and evaluation process or if suspected of non-compliance.
GCP Training for Investigators / sites is offered to ensure that sites are qualified and includes issuance of a Training Certificate upon successful completion.