Clinical Trial Audits
Our experienced staff can audit your clinical trial sites and your clinical trial systems to assess compliance with ICH-GCP and recommend steps to improve your processes, develop your SOPs, and train your staff.
This service is offered to clients who have determined a need to refurbish their Clinical Trial Processes. We can offer expertise and formalized training in change management. The result will be simplified and more efficient processes that meet company objectives as well as regulatory requirements without any unnecessary process steps or bureaucracy.
This service is offered to sponsors and Clinical Trial Sites who need new Clinical Trial Standard Operating Procedures (SOPs), or need to modernize their current SOPs. Through our direct experience with Clinical SOP development, and extensive ICH-GCP expertise, we can assess your needs and develop SOPs that assist your staff in conducting efficient trials and satisfy international regulatory requirements.
Sponsor & Clinical Trial Site Staff Training
We can assess your own and investigator staff training needs then develop and conduct training tailored to those specific needs and objectives.