My Networking Pitch
Balancing the letter and spirit of the law with business needs for the conduct of clinical trials within the pharmaceutical, biopharmaceutical, and medical device industries. I have over 20 years experience in good clinical practice compliance offering the following services:
• Auditing: vendors, investigator sites, documents, TMF
• SOP gap analysis and SOP development
• Training: GCP, ISO 14155, ICH
• Inspection Readiness: general training, SME interview training, and mock inspections