Clinical Quality System Set-Up and Management

SOP Development

Our team at MVG will work closely with you to ensure your Standard Operating Procedures (SOPs):

  • Are uniformly written with detailed instructions to record routine operations, processes and practices followed within a business organization
  • Contain adequate detail to clearly guide research staff through a particular procedure
  • Are aimed at a specific procedure but be written in a general format that can be easily followed so as to avert procedural deviations
  • Reference applicable guidances and regulations within the SOP, such as ICH E6 Good Clinical Practice and 21 CFR 50
  • Have processes established for distribution, education and training on new departmental SOPs to ensure compliance

MVG Consulting SOP writers will meet with your team to determine the process followed in your organization and will tailor your SOPs to your company. They do not take a “one size fits all” approach to SOP writing and will ensure that your SOPs accurately reflect your internal processes and procedures.

mvg clinical trials sop standard operating procedure development

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