Quality and Compliance

Managers must continually anticipate changes in the global clinical, regulatory and commercial environment to allow for efficiency and productivity gains while maintaining quality improvements and GxP standards.

At Kinapse, we work with our clients to:

Manage risk

Adopt a risk-based approach to compliance and quality management which enables alignment of scarce resources to manage the greatest risks.

Continuously improve

Understand the root cause of an issue, correct and prevent through shared learnings, implementing specific plans and signing-off the intervention’s effectiveness. Monitor and detect quality issues through the capture of relevant and specific quality metrics to promote continuous improvement.

Promote compliance excellence

A quality management system needs to be flexible enough to allow for the timely inclusion of improvements into clear, simplified and usable SOPs, which reflect best-practice, to enable operational agility whilst ensuring quality and compliance. High-quality, innovative and timely training helps to reinforce that patient safety and data quality is central to clinical research.

Make global expansion work

Expansion into emerging markets is a challenge due to logistical, language, time zone, travel and cultural challenges. Investigators and site staff from emerging markets may require greater levels of GCP, SOP and therapeutic area training to ensure adequate compliance with the protocol and regulatory legislation. Sponsor companies must demonstrate the necessary oversight.

Develop a culture of inspection readiness

Leading organisations promote a culture of inspection readiness with adherence to all GCP requirements at all times through the study, including filing of documents in the TMF in a timely manner. Quality must be built in to the study from the beginning, not bolted on at the end.

Examples of projects include:

Consulting:

  • Organisation-wide quality and compliance strategy
  • Audit practice redesign
  • Risk mapping
  • Inspection readiness assessment
  • Inspection readiness planning and project management
  • Process mapping and improvement
  • GxP training (FDA, EU Directive, Competent Authority)
  • Corrective And Preventative Action
  • IT solution assessment, selection and implementation management
  • Code of practice approval process improvement

Outsourcing:

  • GxP auditing
  • Medical writing
  • Clinical trial disclosure support
  • Standard Operating Procedure development and maintenance
  • SOP/Procedure GAP analysis

The following are Senior Members of our Quality and Compliance services team: