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Clinical Site Certification Program - Making Clinical Site FDA-Compliant
FDA audits more than a thousand clinics and healthcare centers participating in clinical trials each year and about 40% of these audits lead to major findings. Getting a negative audit by FDA leads to extensive paperwork, legal expenses, pressure on resources, loss of business and other losses for the doctor's office. Are you aware that FDA requires all clinical investigators to be trained every 3 years, at the minimum, in processes outside the scope of medical practice? Are you confident to defend your trials in front of the FDA auditors? Would you like to attract more sponsors? FDAMap introduces the "Clinical Site Certification" program like no other in the industry to train and certify clinical sites. Our industry experts will train you and your staff on all the latest FDA requirements and ways to deal with an FDA audit of your site. You can train all your staff in the convenience of your clinic or a location of your preference. We also offer group training options for multi-clinic practices. Prior to the training, the trainer will work with you to add customized content to address any of your clinic-specific concerns. After the training program is complete, you can be rest assured that your trials would be fully compliant with the governing bodies in the US. You will be confident like never before to deal with a FDA inspector when he or she visits your site. Besides, post certification, the clinical site will act as an attractive hub for the clinical trial sponsors. This 1-day long training will train the site personnel in Good Clinical Practices - GCP, IND, HIPAA, Sunshine Act, Good Documentation Practices for electronic and paper records, and patient recruitment practices. The training complies with FDA's recommendations per the CTTI. At the end of the training, the sites will get a certificate of completion of training that is valid for 2 years from the date of the training. Sites will be provided ongoing support for new staff and trouble-shooting for the duration of the certificate. |
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For additional information on the workshop agenda and logistics, please call +1 877 566 4981 or +1 410-501-5777 or email: info@fdamap.com
