CRI Worldwide

Independant QA Team

Our QA & Regulatory team reports directly to the CEO and has full responsibility for all internal and external audits, developing and maintaining Quality Policies and SOPs and for the regulatory activity of the company. The Director of QA & Regulatory also has the support and expertise of Quality Assurance Analysts (QAAs) and Regulatory Affairs Associates (RAAs) at each research center.

Six Sigma

Six Sigma at CRI means a measure of quality that reaches towards near perfection. It is a disciplined data driven approach and methodology for eliminating defects in any process; from manufacturing to transactional, and from product to service. Through statistical representation, Six Sigma describes quantitatively how a process is performing and to achieve the Six Sigma benchmark a process must not produce more than 3.4 defects per million opportunities. Within this context a defect is defined as anything outside of customer specifications.

Process improvement and variation reduction are fundamental objectives accomplished through the application of Six Sigma improvement projects. Under the direction of a Six Sigma Master Black Belt, Six Sigma DMAIC (define, measure, analyze, improve, and control) and DMADV (define, measure, analyze, design, and verify) improvement processes are executed by Six Sigma Green Belts and Black Belts. The Six Sigma DMAIC process is an improvement system for existing processes that are falling below specification and looking for incremental improvement. The DMADV process is an improvement system used to develop new processes or products at Six Sigma quality levels.

Research Assistants and Clinical Team

CRI has at least one Research Assistant (RA) for every two CRCs. The RAs work with the CRCs to ensure the quality execution of each trial. They are also a critical component of our clinical QC process. Research Assistants monitor all CRFs within 24 hours; a physician reviews all ECGs within 24 hours and labs within 48 hours; filing of all ECGs and labs, once reviewed by a physician, is completed within 72 hours. In addition, record reviews are ongoing as the RAs implement specific tools to aggregate and analyze all findings. Reports are generated to show trends and to assess the ongoing need for process modification.

Training and Staff Development

At CRI, we take staff development and training very seriously. As part of the clinical operations team, CRI develops and delivers all training including: roles and responsibilities, job functions, work instructions, quality policies, SOPs, regulatory and patient recruiting. We also collect weekly audit data and providing feedback to the clinical teams in regular monthly quality review forums.

Since we have employee certified clinical research coordinators, continuing education is ongoing. In addition to our internal training, CRI provides an accredited, annual, in-house seminar for all staff members. This seminar and other internal workshops provide information on new developments and/or revisions to FDA, GCP and ICH guidelines.

Institutional Review Board (IRB)

CRI Worldwide utilizes centralized IRBs, including Western, Copernicus, Schulman, Biomedical, Quorum, IMTCI and Chesapeake; we can also utilize others when requested by our sponsor/partners.

CRI Quality Policies

The purpose of this Corporate Policy is to specify the minimum attributes that all processes at CRI Worldwide must have to ensure quality. This policy applies to all CRI personnel involved in providing Phase I to IV study services.

Executive Management Team (EMT) Responsibilities

The Executive Management Team, members of which are shown below, has the following responsibilities:

• Developing, periodically assessing, and, if required, revising the policies;
• Allocating adequate resources for establishing and maintaining a Quality System;
• Reviewing and periodically updating the Quality System; and
• Assuring that regulated activities performed by CRI conform to the requirements as established in the Quality Policy and its related procedures

Policies Maintained

There is a separate policy maintained for each of the following areas:

• POL-001: Quality
• POL-002: Principal Investigator Responsibility
• POL-003: Informed Consent
• POL-004: Subject Safety
• POL-005: Management of Information
• POL-006: Compliance with Laws and Regulations
• POL-007: Training and Development
• POL-008: Records Management

The Executive Management Team

The Executive Management Team signs off on all policies and consists of the following:

• Chief Executive Officer
• Chief Scientific Officer
• Vice President, Clinical Operations
• Medical Director

CRI Standard Operating Procedures (SOPs)

CRI maintains a full set of SOPs for each site which are consistent with our Quality Policies. These policies are reviewed and updated regularly. They are also the subject of regular training and review with the clinical staff at weekly staff meetings and staff development activities. CRI’s SOPs cover the following areas:

Section 1: Administrative

• SOP 1.0 Pharmaceutical Clinical Trial Site
• SOP 1.1 SOP Generation and Revision
• SOP 1.2 CRI Management's Rights and Responsibilities
• SOP 1.3 Clinical Trial Feasibility
• SOP 1.4 General Delegation of Authority

Section 2: Regulatory and Quality Assurance

• SOP 2.0 Sponsor Submissions
• SOP 2.1 Institutional Review Board Submissions
• SOP 2.2 Informed Consent
• SOP 2.3 Consent for HIV Screening
• SOP 2.4 Subject Confidentiality
• SOP 2.5 Responsibilities of Investigators

Section 3: Clinical Trial Conduct

• SOP 3.0 Study Initiation Procedures
• SOP 3.1 Regulatory Binder
• SOP 3.2 Subject Clinical Trial Records
• SOP 3.3 Source/Workbook Development
• SOP 3.4 Patient Recruitment
• SOP 3.5 Patient Screening Visit
• SOP 3.6 Technical Clinical Procedures
• SOP 3.7 Clinical Laboratory Procedures
• SOP 3.8 Investigational Product Accountability
• SOP 3.9 Dispensing Investigational Product
• SOP 3.10 Scheduling Visits and Contacting Subjects Lost to Follow-up
• SOP 3.11 Discharging of Subjects
• SOP 3.12 Source Document Completion
• SOP 3.13 CRF Completion
• SOP 3.14 Adverse Events/Experiences
• SOP 3.15 SAEs and SADEs
• SOP 3.16 Study Close-Out
• SOP 3.17 Study Document Retention and Storage
• SOP 3.18 Data Clarification and Queries
• SOP 3.19 Monitor Conduct
• SOP 3.20 Sponsor Audits
• SOP 3.21 FDA Audits
• SOP 3.22 Clinical Trials Conducted at an Off-Site Location
• SOP 3.23 Computerized Systems Used in Clinical Trials

Section 4: Health, Safety, and Education

• SOP 4.0 Health and Safety
• SOP 4.1 Universal Precautions
• SOP 4.2 Disposal of Bio-hazardous Waste
• SOP 4.3 Clinical Equipment and Maintenance
• SOP 4.4 Staff Training and Education
• SOP 4.5 Quality Improvement