Clinical, Quality Assurance and Safety
To ensure that the true risks of clinical research and development are appreciated and managed, life sciences companies must protect themselves in an increasingly complex research environment. Most importantly, by effectively managing, risk life sciences companies can increase the chances that the goal of such research – bringing new and improved therapies to patients with unmet medical needs – is achieved.
Our team helps companies develop a sound clinical strategy, manage clinical operations smoothly and meet or exceed industry standards. We also work to ensure compliance with study protocols, Standard Operating Procedures (SOPs) and regulatory requirements by providing consulting services on Quality Management Systems (QMS) standards and requirements, QMS gap analyses and continuous improvement programs as well as SOP development, harmonization, review or revisions.
Our team can evaluate current domestic or global compliance risks, provide a road map to achieve an outstanding clinical compliance program, develop key compliance, performance and quality metric tools to monitor both internal Good Clinical Practice (GCP) compliance and that of vendors performing outsourced clinical research operations. Our team also integrates company-wide compliance management platforms that include overarching Corrective and Preventive Action (CAPA) plans, electronic data management systems (EDMS) and audit management, employee training and change management capabilities to address clients’ GCP compliance and performance improvement needs. In addition, our team works with clients to design more efficient processes to address clinical regulatory developments including clinical trial registries, adverse event reporting and data privacy.
Our team employs a variety of training methodologies, from direct presentation to group and individual exercises, case studies, role play and workshop environments. These are designed in consultation with clients to maximize the learning benefits for intended participants.