Preparation Of SOPS

Additional Details

Trial specific regulatory/compliance and clinical advice and strategy at the early stages of product development can be critical to the ultimate approval of the product. Failure to address regulatory and compliance concerns early in the development program often results in delays in approval due to improperly designed studies, omitted studies, manufacturing oversights and other failures to meet key regulatory requirements. Timely submission of all trial related documents, including proper Standard Operating Procedures, could play a crucial part in the sponsor’s decision to accept the site for specific trials. Academy of Clinical Research professionals are highly versed in generating site specific SOPs, and proper completion and submission of all required regulatory file documents and logs.