Monitoring clinical studies both with pharmaceuticals and medical devices in all indications:
Evaluation and selection of sites
Initiation of clinical studies
Training and qualification of site staff
On-site and off-site monitoring
Correspondence to ethics committees and regulatory authorities
Investigator Site File and Trial Master File reconciliation
Close out activities and archiving of documents
As a further service I am offering:
Co-monitoring: Support and Coaching of CRA`s within your company. Transfer of working techniques and interpersonnel skills for successful monitoring on site
