Quality Assurance Parameters

Objective:

• Meridien Research’s Quality Assurance Program was designed to ensure high quality data in the setting of quality care for all of our research subjects.

• The Quality Control Process is the ongoing effort to maintain the integrity of our processes and assure the reliability of data collection and achieving our desired outcomes.

• This program also includes Quality Improvement which is the purposeful change of a process to improve the reliability of achieving our desired outcome.

• Our goal is to ensure that all the activities necessary to design, develop and implementation are effective and efficient with respect to systems and performance.

• This program details the planned or systematic actions necessary to provide enough confidence that the end product satisfies and or exceeds Meridien Research’s and the Sponsor requirements for quality

Process:

• Quality Assurance (QA) is performed on a monthly basis at each of the Meridien sites.

• A different topic for review is chosen for review each month. Topics are chosen based on practice based processes.

• Results from each site are reviewed monthly by the QA Program Coordinator then presented for review to management.

• The goal of the program is to identify areas that may require changes in process and/or additional training needs of staff.