Clinical Quality Assurance

BMP Group understands how important it is to your company that your systems work efficiently and comply with current regulatory requirements. As the legislation governing clinical trials changes, it is vital to meet regulatory expectations and still remain competitive in the marketplace.

The effectiveness of your clinical quality system determines both the success of your clinical trials and whether your company will easily pass inspections by regulatory agencies. Thus, your clinical quality system is a key component in building a solid reputation within your organization and with regulatory authorities.

BMP Group has highly experienced and knowledgeable consultants who can help you create a clinical quality system if one does not exist currently in your organization, and objectifively assess existing clinical quality systems to identify any gaps or deficencies. Our consultants can ensure your clinical quality system meets global quality and compliance requirements, including US, EU, Japan, Canada, Australia, Brazil, Argentina, and India.

Our Consultants can help you prevent the problems that result in unapproved trials, clinical holds, and unapproved products, as well as help ensure you do not experience a negative and embarassing audit outcome from a regulatory inspection.

Clinical Quality Assurance Services Include:

  • Protocol and report review
  • Regulatory agency audit preparation
  • Internal and external audits
  • Acquisition due diligence
  • SOP development
  • Providing employee training programs
  • Gap assessment
  • Clinical quality system creation

Contact BMP Group by email or at (650) 743-2465 to discuss your individual needs.