CRI Lifetree’s Statement of Quality Commitment:
CRI Lifetree holds itself to the highest standard of ethics and integrity with the goal of exceeding our client’s expectations. We are committed to the highest level of quality in the performance of clinical research and the protection of human subjects. CRI Lifetree is committed to providing high quality clinical data, which are accurately supported by source documentation, based on applicable GCP regulations, related guidance documents and CRI Lifetree Standard Operating Procedures (SOPs) and Work Instructions (WIs). CRI Lifetree has established A Quality Management Program and will obligate to maintain this program in order to meet these commitments.
CRI Lifetree’s Quality Management Program consists of all company functions, processes, and activities that affect the quality of the company’s products and services.
To promote awareness across the company that this QMP is the foundation of who we are and what we strive to represent each and every day, a written declaration of our commitment to quality and quality improvement throughout the organization.
CRI Lifetree has developed and implemented a QMP as a means of demonstrating our commitment to provide quality focused clinical research services that consistently meet the rigors of internal stakeholders, our sponsor’s expectations and, applicable regulations.
All Employees and contractors engaged in company business that may affect the quality of company product and/or services have job descriptions and associated job specific training curriculums to ensure they receive the necessary training to perform their job functions.
Quality Control QMP Activities Include:
Quality Control activities support start-up activities and assess the site performance before, during and after execution of a clinical investigation. Quality Control includes all operational techniques and activities to verify that the trial-related requirements for quality have been fulfilled and this applies to each stage of data handling.
Quality control activities before, during and after project are weaved throughout the company and is performed by every member of the project team.
Identify areas in need of corrective and preventative action.
Discovery, reporting training gaps with follow up to ensure training and or re-training are implemented.
Quality Assurance QMP Activities Include:
Quality Assurance activities include planned and systematic audits to ensure that company Quality Control activities are working and effective.
Quality Assurance activities identify training gaps.
Quality Assurance will provide clinical staff, investigators and executive management with Key Quality Indicators (KQI) and priorities for improvement.
Key quality indicators are selected performance areas and activities that are vital to compliance with accepted industry standards of performance and best practice.
Identification, team discussions, reporting, tracking and trending KQIs are critical to increasing the effectiveness of the QMP.