QUALITY SYSTEMS SUPPORT & CONSULTING
The clinical research industry requires integration of a quality risk management approach to increase subject safety and data integrity, while also promoting working smarter to support project cost containment and affordability. This is a time for stakeholders to have efficient clinical quality management systems to support this balance between safety, cost, timeliness, compliance, and more. Clinical Pathways supports sponsors, CROs, and sites to identify gaps and implement changes. Let our consulting experts help your organization proactively prepare for audit readiness.
Clinical Pathways promotes better clinical quality systems for our clients to support focusing on what is essential and truly matters. We facilitate the hard questions being asked and answered. This can be done by gap analyses and root cause analysis to support the development of new or revising existing policies, procedures, training materials, and programs to meet current and new industry regulations, and your company success factors.
Some examples of these services are:
Quality manual development and updates
Quality management system health assessment and root cause analysis for recommended updates
Procedure development and revisions
Training development and deployment
Audits of programs and facilitation of updates
Gap analysis