Many organizations have Quality Management Systems that were implemented prior to the implementation of some of the newer guidance and regulations governing Clinical Research in human subjects. These systems can benefit enormously from a health check, resulting in clear and pragmatic suggestions for improvement in order to better align with current regulatory expectations, to adopt 'best practices' and generally operate in a smoother and more efficient manner, allowing seamless integration of the Quality Management System across the organization, and making the QMS a system that allows a balance of flexibility and pragmatism, while still maintaining the highest levels of compliance and quality.

Organizations often wait until the reality of an inspection is looming before addressing the preparedness of the organization, its systems and personnel to receive and, most importantly, get through an inspection with no major or critical findings. Getting ahead of the curve and operating in a state of inspection-readiness is 'nirvana' for Preclinical and Clinical companies. Clinical Quality First can conduct a gap analysis, perform inspection-readiness training, and perform mock inspections to assure a positive outcome for any regulatory inspection. Clinical Quality First can support the production of optimally pitched storyboards, advise and consult on inspection hosting strategy, and prepare employees likely to be interviewed during an inspection, which can be a daunting experience for even the most proficient and knowledgeable of staff.

The saying 'if you fail to prepare, prepare to fail' was never truer than when ensuring your organization is ready for a regulatory inspection.

Selecting and implementing a system to support any aspect of your Quality Management System or clinical trials can be a daunting proposition without the correct experience and knowledge. Whether it is an electronic Trial Master File, Clinical Trial Management System, electronic Quality Management System, Clinical Quality First can guide and support this process so that the end result is a system that meets the need of the organization and is fit for purpose.

The driving passion of the founder of Clinical Quality First, designing and implementing new Quality Management Systems is one of the key specialties offered. The implementation of a Quality Management System is a pivotal point in the development of any new company, and a key factor in determining success of that system is within the flexibility and scalability of the system, particularly in times of growth and change. It's often overlooked as a key stage in development, and something that is considered after-the-fact. To find out more about how a simple, pragmatic but effective and compliant Quality Management System can be implemented, contact Clinical Quality First.

Audits are a critical element of verification of quality and compliance at every stage of preclinical and clinical development. Clinical Quality First can conduct audits of every type, and can ensure your vendors/third parties are qualified and re-qualified according to industry standards and expectations. Clinical Quality First can audit Investigator Sites to assure the quality and integrity of the data, and the safety of the subjects participating in clinical trials.

In the event of specific concerns, Clinical Quality First can conduct for-cause audits to investigate potential cases of fraud and / or misconduct.