• Regulatory Document Preparation
To assist the site to make sure all documents are correct, AGR personnel will prepare the regulatory documents for the site. These documents will be submitted to the proper agencies and then followed to make sure that the client is best served.
• Establishing SOPs and working procedure
SOPs and Working Procedures are created at each site to meet the requirement of the AGR Regulatory and Clinical Trial Management departments.
• EC/IRB submission
Because of the years of experiences that we have in EC/IRB reviewing processes and ethical issues surrounding it, we can provide training, assistance in preparation of informed consent documents and recruitment materials that should meet EC/IRB requirements.
• Investigator and personnel training
Through connections and our own capacity that have been established, training of personnel in ICH/GCP can be arranged by our group and share our experiences both from a site and a CRO perspectives.
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