Quality Analysis


What does mean Quality Assurance?

  • Generally speaking, it is any systematic process of checking to see whether a product or service being developed is meeting specified requirements.
  • In case of clinical research, the process ensure the application and the maintenance throughout the clinical study of the ICH-GCP and the local regulation as well as the Standard Operating Procedures in force.


Why is Quality Assurance crucial?

  • Because it ensures the respect of GCP and local regulations from which directly depend the right, safety and well-being of the participating subjects.
  • At the company's level, offering quality assurance services reinforces the customer confidence and the company's credibility. It also helps to improve work processes and efficiency.
  • MTA can provide a personalized analysis of your needs in terms of quality for a specific offer after evaluation on a case-by-case basis:
    • Support on developing of SOPs adequate for your projects
    • Support on the developing of the internal SOPs adequate to your Company (if needed)
    • Execution of external GCP audit at investigational sites
    • Execution of external GCP audit to your provider s of activities related to clinical trials


CROm

  • What is it? Performance analysis dedicated software exclusively developed by MTA with a broad range of applications
  • What are the applications?
    • Common data: all data related to clients and providers, hospitals...
    • Financial Accounting: all data related to the invoices to check and approve
    • Personnel: management of team work through various entries into the timesheet
    • Quality: template of documents, SOP and registration of final documents
    • Reports: extraction of data summary from invoices and timesheet
    • ...
  • Why using it? This tool allows the optimization of the internal study management at several level.
  • Are you interested? If you think that CROm would be a suitable tool for your business, please feel free to contact us to know more about this amazing tool !