road to quality clinical trials
TRANSCRIPT
“Road To Quality Clinical Trials” Dr. Nilu Bha,a, Manager Quality Assurance
A JSS Medical Research Company
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Road To Quality Clinical Trials
Quality Policy Max Neeman International is committed to providing quality services to both external and internal customers. We ensure this by using robust quality matrices. We shall continually strive to achieve it by benchmarking all our processes against global quality standards. ‘Max Neeman’ undertakes a number of quality initiatives, including ISO certifications and internal audits to ensure that it is following standardized internal processes and best practices in the organization. Being in a quality driven industry we follow a robust system of quality control processes and all our operational activities are governed by strict adherence to ICH-GCP guidelines, local regulations and well laid out SOPs.
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Tools To Ensure Quality
q Build quality into the system
q 21 CFR Part 11, compliant system
q ISO Certifications for Site Management, Monitoring & Clinical Data Management, Information Security Management System (ISMS) & Clinical Investigational relating to Medical Devices
q Well Laid out SOPs
q Train and educate site personnel, project team and reviewers / auditors
q A dedicated Quality Assurance team of qualified and experienced personnel to ensure and implements quality standards
q Regular compliance audits
q System oriented project execution plan - ensures high quality standards and uniformity of clinical trial conduct
q Continuous trainings on SOPs, ICH-GCP(E6) and other applicable regulatory guidelines
q Standardize formats and procedures
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5 Steps of Continuous Quality Management
Plan & Prioritize
Control & Report
Monitor Identify
Analyze
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Work Environment and Robust SOPs
q Promote high quality work environment by: q Establishing and deploying work systems through well-defined SOPs q Adherence to ISO systems and processes q Empowering QA department to conduct internal audits based on
approved quarterly plans q Acting upon QA observations in weekly & monthly meetings
q Robust SOPs
q We place great emphasis on developing SOPs and updating them at frequent intervals to ensure quality and service excellence to all our customers. The QA department, with the help of respective SBUs, develop SOPs to standardize the quality of work. These SOPs are then reviewed annually depending upon the latest development and feedback from respective departments/customers.
q The SOPs have been carefully drafted within the boundaries of ICH E6, applicable regulatory guidelines and the detailed steps involved in the conduct of a Clinical Trial across all Phases (Phase I to IV)
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International Quality Certifications
q Quality Management System: ISO 9001: 2008 - ISO 9001:2008 sets out the criteria for a quality management system and is based on quality management principles including a strong customer focus, process oriented approach and continual improvement. ISO 9001 helped us to ensure that all our customers get consistent, good quality services through the life cycle.
q Information Security Management System: ISO 27001:2005 -
ISO 27001:2005 specifies the requirements for high quality GCP-compliant data management. It also specifies the requirements for the implementation of security controls to ensure data security and compliance. ISO 27001:2005 is designed to ensure the selection of adequate and proportionate security controls that helps protect information assets and give confidence to customers.
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International Quality Certifications (continued)
q Management System for Clinical Investigational plan relating to Medical Devices: ISO 14155: 2011 - ISO 14155:2011 specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
q Assessed for Malcolm Baldrige Performance Excellence Program -
Malcolm Baldrige was designed to raise awareness of quality management and recognize the companies that have successfully implemented Quality Management Systems. Malcolm Baldrige Provides a set of criteria to improve performance by focusing on two goals: delivering value to customers and improving the organization’s overall performance.
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MNI Therapeutic Experience Types&of&Audit& Number&To&Date&
USFDA&&Audits& 8&
DCGI&Audits& 6&
Client&Audits& 83&
System&Audits& 16/Year&
Finance&Audits& 1&half&Yearly&
&
Max Neeman Audits
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Quality Framework
*Indian Council of Medical Research
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To Learn More
Contact Information: Ann Vawter Director, Business & Marketing Max Neeman International 117 Edinburgh South Dr., Ste 105 Cary, NC 27511 P: 919.424.3332 / F: 919.852.5574 E: [email protected] www.neeman-medical.com