The Client: A Major BCBS Affiliate

Overview

Performance excellence and unmatched record of quality delivery set the Company apart in the challenging and precarious world of clinical research where every well-calculated detail contributes to human health and every minute wasted prolongs the reach of the drug to patients, not to mention the lurking hazards of potential controversy and losses at every step. Therefore, absolute compliance to worldwide regulations as well as requirements, clinical trial protocols and validation protocols of pharmaceuticals involved in the extensive and intricate processes of clinical research is completely mandatory to the Company.

Clinical research determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimes intended for human use. It spans the entire lifecycle of a drug starting from its inception in the laboratory to its introduction to the market and beyond. When a potential molecule is identified in the laboratory, it is subjected to animal studies where different aspects of the drug are studied. In the United States, the data obtained from such pre-clinical studies are submitted as an Investigational New Drug (IND) to the Food and Drug Administration (FDA) for permission to conduct human studies.

The clinical studies on humans are conducted in four phases. Being directly related to human life and health, these clinical trials are closely supervised by appropriate regulatory authorities. All studies that involve a medical or therapeutic intervention on patients must be approved by a supervising ethics committee before the start of the trial.

Operating in such a sensitive, impacting and quality-centric area, the Company took the decision to further enhance its quality and compliance management by automating audit management and corrective action/ preventive action (CAPA) planning.

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Solution

The Company needed to automate and streamline its audit management and CAPA management for ensuring complete compliance with all applicable regulations and detecting and correcting any adverse events early on. The clinical quality assurance team at the Company was looking for a solution that would be flexible, scalable and one that could be rapidly deployed, validated, and adopted.

Based on extensive research and analysis of market options, MetricStream was endorsed as the desired solution provider. MetricStream’s profound domain expertise in the clinical research industry along with the strength of its technology platform to support the compliance, risk and audit requirements of large organizations formed the foundation for this selection.

MetricStream delivered an out-of-box solution built on its leading GRC platform that met all the requirements of the Company.

MetricStream’s GRC Platform: Deployed on MetricStream GRC Platform, the solution is a comprehensive, Web-based application that provides a common framework, complete automation and integrated approach to quality management processes and initiatives at the Company.

MetricStream’s platform maps to the Company’s complex organizational model across all the countries that it has offices in, business units and departments, along with its different roles and reporting relationships. Role based views and access control further strengthens the solution. The application facilitates report generation of packaged executive reports while ad hoc/customized reports can also be configured. MetricStream’s integrated solution can be accessed by over 3,600 associates of the Company across the globe.

Audit management: MetricStream provided the Company a comprehensive audit management software designed to manage a wide range of audit-related activities, data and processes.

The Company’s clinical quality assurance auditors need to audit various phases of clinical research involving a number of departments and teams. MetricStream Solution allows the auditors to maintain an audit schedule in a logical structure and hierarchy with separate audit templates for different phases as well as for various teams and departments.

The administrative staff at the Company can schedule periodical audits or trigger audits on an ad-hoc basis for internal departments, or for specific phases, processes and projects. Auditors can confirm the audit assignment and completion of audit and record audit results indicating conformance or non-conformance.

Clinical quality audits are varied in nature and can involve a range of diverse activities. Using the automated system, the clinical quality assurance auditors at the Company can define detailed checklists and tasks that need to be performed for executing the quality audit. The auditors can track specific action items and critical failures which are flagged by the system.

When audit results are posted, the relevant teams receive automatic alerts. Recommendations sent by the auditors are tracked to ensure their implementation for closed-loop audits.

Corrective and Preventive Action: MetricStream’s corrective action software supports identification, evaluation, segregation and disposition of nonconforming issues during phases I-IV, including early and late stages, of clinical development.

Based on the industry standard 8D methodology, the CAPA software provides exception and change management and captures non-conforming data during the clinical trial phases. Using the application, the clinical quality team at the Company can conduct investigation to determine the root cause of the issue, manage the entire preventive and corrective process, implement changes, and ensure that the non-conformance is resolved effectively.

Graphical dashboards track each case from initiation to closure and present complete real-time visibility into the quality system to the clinical quality managers at the Company.

The solution allows the quality team to initiate a nonconformance incident and assigns a unique case number to it to track the incident through various stages. It captures detailed information about the issue and supports categorization of issue type based on pre-defined criteria, severity level and the responsible department. The solution also supports correlation with past data for quick analysis and decision on the need for containment or corrective action.

The CAPA system assigns the investigation task to an owner based on the responsible department and incident type. Depending on the severity, a cross-functional team of investigators may also be assigned the task. Root cause analysis can be conducted through automated workflows to identify the source of the incident and categorization of the type of issue such as a process issue, human error or equipment problem. The application allows the owner to design a detailed action plan with an estimated completion date and allocate responsibility to various members.

Approval of the plan sends automatic task assignment to appropriate users with assigned due date. The user’s failure to act in time triggers escalation emails to quality managers. Quality managers can track the status of the action plan based on pre-defined milestones. Cases and incidents with high severity can be marked for a follow-up after a specific time period to confirm effectiveness of the action. The results are routed back to the quality unit for approval and final closure of the action plan.

Why the Company Selected MetricStream?

MetricStream has deep domain expertise in the life sciences industry and in implementing GRC solutions for global players with a strong knowledge of the nuances of the sector.

MetricStream possesses the capability to configure and deliver completely out-of-the-box solution mapping the Company’s specific process requirements.

MetricStream solution includes evolved analytical and reporting capabilities to generate quick standard reports as well as to configure a wide range of ad hoc reports.

MetricStream has the ability to support large organizations and meet their IT requirements in the areas of integration, configurability, scalability and security.

Challenges

Manual audit and CAPA processes: The clinical quality assurance team at the Company conducted audit related activities such as audit scheduling, assignment, communication, and audit follow-ups in an informal manner using spreadsheet-based, free-form, manual processes, phone calls and emails. Audits as well as CAPA were tracked manually exposing the processes to human errors, duplication of work, long completion periods and other such shortcomings associated with non-automated processes.

Lack of flexibility and scalability in legacy solution: The Company was using a metrics and audit report tracking system on global level. However, this point solution lacked the flexibility and scalability to support the Company’s diverse reporting needs.

Insufficient visibility and reporting: The Company did not have sufficient visibility into the audit and reporting metrics implying an impact on overall compliance and thereby incurring a risk to the validity of clinical research findings. The lack of visibility was also hampering effective resource management and recruitment of management team for the director of quality.

The reports required by the quality team could not be generated quickly. Report creation took hours or days, affecting the timelines for important decision-making. This was a particularly major challenge for early stage studies where the Company needed to help its clients reach an informed decision quickly and determine early whether their products have the potential to move forward into the marketplace.

In addition, certain analytical functionalities were proving to be impossible using the manual approach and made it difficult to facilitate accurate decision-making based on comprehensive analysis.

Need for foolproof compliance: The Company requires to be compliant with a number of regulatory and government standards such as 21CFR Part 11, Sarbanes Oxley (Sox), FDA, Good Clinical Practice (GCP) regulations, International Organization for Standardization (ISO) regulations. Ensuring complete compliance with these regulations through foolproof audit and corrective and preventive actions was a challenge that the Company was striving to meet.

Customer Quote

“Quality of service and a commitment to continuous improvement distinguish our organization in the marketplace. Critical initiatives, such as the MetricStream implementation, enhance the organization’s ability to anticipate and respond to the constantly changing environment in which we operate. Enhancing our quality management system with the MetricStream platform has improved cycle times for our clients, as well as reduced regulatory liabilities, risks, and costs for us and our clients,” said the spokesperson of the company.

Benefits

  • Reduced cycle time:
    Automation of audit management and CAPA management, quick and easy access to necessary reports, analyses, dashboards, heat maps and visual aids have sped up the clinical trial phases I-IV. Quicker checks, reviews and approvals have reduced the cycle time for drugs, devices, diagnostic products and treatment regimes, helping the Company’s clients to market the products faster.
  • Enhanced compliance:
    Organized and automated auditing along with the capability for closed loop audit has brought the audit findings to light. The workflow-based processes have ensured that these findings are acted upon on time. Streamlining the audit management activities and following systematic CAPA processes has controlled noncompliance and strengthened the compliance of early through late stages of research with client protocol as well diverse applicable regulations. This reduces the number of FDA or customer audits as well as nullifies the probability of FDA fines, losing customer contracts and loss of goodwill and reputation.
  • Optimum precision and productivity:
    MetricStream solution captures every nonconformance incident in various phases of clinical trials, tracks such cases through systematic stages and ensures appropriate closure and corrective action plans for prevention of similar incidents in future. This has considerably restricted incidents of oversight and nonconformance with FDA standards increasing the productivity of the quality team in particular and the enterprise in general.
  • Cross-organizational visibility:
    By providing a common integrated platform for all quality processes and initiatives including audit management and CAPA management, advanced capabilities for reporting and analytics, the quality team has gained clear visibility into the performance across the Company’s enterprise.
  • Decreased audit costs:
    With automated and streamlined audit activities, the quality team resources can focus their efforts on high risk areas. The entire audit lifecycle is covered by the solution leaving little room for the assistance of external auditors and consultants and thereby reducing the audit fees for external auditors and eliminating ad hoc and unplanned staffing costs.

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