Avoiding the Risks and Costs of Poor IT Quality: Computer System Validation for Clinical Trials

Between 40-60% of software defects can be traced back to errors made during the requirements stage.

In anticipation of next month’s GIQAR conference in Verona, Italy, ARITHMOS discusses the risks and costs associated with poor IT quality in the clinical trial environment. Implementing best practices for Computer System Validation will help Sponsors comply with regulatory standards and avoid paying high costs for IT support and bug fixing down the road. 

scheiThe costs of IT quality can be an investment: from documented planning and prototyping to review and inspection and test execution. However, the costs associated with poor quality normally outweigh the costs associated with good quality.

Defect correction, including diagnosis and bug fixing, can produce enormous costs for companies. More importantly, external failure can cause huge losses for a company. Operational defects can lead to lost productivity and lost sales. On a more serious note, it can lead to a delay in new drug approval or even regulatory fines.

The FDA has taken the initiative to improve IT quality in both clinical practices and manufacturing. In just the past decade, several pharmaceutical cases have been brought to justice under the FDA’s strict policies:

  • Case 1: a pharma company was fined $297 million USD plus 18.5% of drug sales; the drug was discontinued and 2 manufacturing plants were closed
  • Case 2: a pharma company faced a $650 million USD financial penalty and the closure of its manufacturing site for failure to meet quality standards for diabetic medication

Computer System Validation (CSV) is one way to ensure IT quality and provide documentary evidence (such as plans, records and reports) to guarantee a system works as it should. CSV can prevent software problems before reaching the usage environment.

The FDA is aiming to strengthen its CSV standards by aligning them with international standards like ISO 9000:2000. 21 CFR Part 11 compliance is required for electronic records and electronic signatures. CSV is essential in this case because the FDA requires all computerized systems with GxP electronic records to be validated.

stock-footage-portrait-young-female-hospital-doctor-using-computer-to-input-data-on-clinical-trialsEU Annex 11 requires that all computerized systems used in GxP-regulated environments are compliant in order to ensure integrity of records and data. It applies to the European Union and all foreign manufacturers who are seeking EU market approval.


How can companies ensure IT quality?

Quality means that the systems and the services you deliver meet specifications and is achieved by providing the desired functionality with minimum defects. A quality product has the following attributes:

  • Usability: it does what you expect
  • Availability: it is ready when you want it
  • Reliability: it does not breakdown and has a long shelf life
  • Maintainability: if it does break, you can fix it; if requirements change, you can modify it
  • Trustworthy: you know the end result – always
  • Affordability: the value to the business outweighs the costs

ARITHMOS has extensive experience in validating systems in the healthcare sector. To ensure patient safety and full adherence to regulatory requirements, we validate regulated systems in a cost-effective, efficient and fully compliant manner. We provide full evidence of the validation exercise, and when requested, fix non-compliant areas. For inquires regarding our CSV consultancy services, send us an email at info@arithmostech.com.


Technology Considerations for Successful Risk-Based Monitoring

ARITHMOS is participating in this year’s ePharma Day series across Europe which highlights the importance of risk-based monitoring for clinical trial operational efficiency. Technology plays an important role in successful risk-based monitoring practices in order to conduct 100% source data validation (SDV) at every investigational site. How can technology transition from “common” processes to a RBM approach?

Image_Feb_VitalSync500-466x270Risk-based monitoring (RBM) of clinical trials is an approach that combines on-site monitoring along with centralized remote monitoring by coordinating centers. Based on risk assessments about how the clinical information is captured and protocol is designed, risk-based monitoring activities can be proactively supported by the usage of reporting tools.

The FDA and EMA issue guidelines encourage the use of electronic systems and strategies to identify and prevent risk factors for the quality of data, patient safety and trial integrity.

Electronic Data Capture is an essential part of a RBM technology strategy since it captures data in real time. EDC allows Investigators to capture and monitor site activity remotely, however EDC only captures part of the picture. The EDC system itself captures data and determines which data needs to be verified and analyzed. Although most EDC systems provide built-in reports to support data management activities, other metrics and information which are needed to verify the risk-based approach are not provided to final users. Key information that might not be provided by the EDC system include:

  • Site information to get recruitment activities at the site level
  • Subject status: information about the screening status, screen failure, enrollment etc
  • eCRF status: how many eCRFs have been completed and/or verified?

A risk-based monitoring approach technology strategy should also include analytical business intelligence tools. By using a business intelligence tool to query the EDC database, reports can be designed depending on the targeted audience involved in the trial review including project and data managers, site staff, clinical monitors and safety staff. Reports with centralized monitoring metrics that assess site activity, including recruitment, CRF completion and DCF resolution, can be easily made available for quick analysis and decision-making. Clinical data visualization and analysis is especially important to aggregate data across multiple systems and even multiple studies.

Data Visualization tools now make it possible to collect data from multiple sources, even disparate databases, and display the data in a structured format for all members of the clinical team. An added value is the ability to drill-down data and click-through multiple levels of details to aid in analysis. Tools available today are generally cloud-based which means Sponsors avoid the technology hassle of HTML or plug-ins and enjoy the convenience of data “on the go”.

The intangible benefits of analytical tools for risk-based monitoring are apparent, especially the ability to create ad hoc reports on site information, safety and efficacy, drug supply and patient management. The return on investment from the implementation of these tools is the amount of time saved by being able to access and analyze data immediately and using the data to identify and fix problems.

ARITHMOS’ Gianluigi Albertini will be presenting at the ePharma Day series on “Business Intelligence: Analysis of metrics and effective technology supporting Risk based monitoring in clinical trials”. ePharma Day 2014 focuses on Risk Based Monitoring in Clinical Trials and discusses the importance of developing an overall risk assessment plan, better tools for a holistic and dynamic oversight of site activity and the critical items Auditors will consider for guaranteeing GCP compliance. The first two ePharma Day events are scheduled for 27th of May in Milan, Italy and 26th of June in Frankfurt, Germany.  


ARITHMOS Launches Version 2.4 of ArithmosCentrum ERP

ARITHMOS released ArithmosCentrum Version 2.4, a new and extended version of its proprietary Enterprise Resource Planning (ERP) system. This release delivers new features to further empower organizations wanting to extend their capabilities in managing bids, projects, invoicing and sales reporting.

Business charts

Highlights of the new release include:

– Web-based Features: Project requests can now be entered and reports can be accessed via the web with ArithmosCentrum’s new reporting engine. This allows real-time access to key reporting metrics.

– New Functions
– Customer and supplier invoicing, a feature not previously available in ArithmosCentrum which now completes the financial component.
– Project “copy and paste” function to speed up project plan production
– Transport Documentation (DDT) from timesheet/material input
– Audit Trail of all operations performed

– Added Value Functions: Version 2.4 includes system upgrades to facilitate day-to-day operations including project management, project export to Microsoft® Office Project and integration with Microsoft® SharePoint®, SalesForce®, Microsoft® Office Project Server and BOARD®.

– Intuitive Upgrades: In order to improve the intuitiveness of ArithmosCentrum, Version 2.4 features a new menu interface, report customization at entity level, supplier management at the project level and product configuration to manage feasibility.

ArithmosCentrum is available in different editions and pricing models. Visit the ArithmosCentrum website for the various editions.