Ask the Experts: Computer System Considerations for Pharmacovigilance Data Migration

Adaptive Trial DesignWhen it comes to safety systems, pharmacovigilance professionals must take into consideration the guidelines and legislation laid out my regulatory agencies. Computer systems used to manage safety data are subject to rigorous validation testing to determine if they are suitable to manage safety data in the clinical environment.

Last month, ARITHMOS hosted the second edition of Pharmacovigilance Day in Milan, a seminar which invites pharmacovigilance professionals to meet and discuss the industry’s most pressing issues. This year, a senior PhV Inspector from the Italian Pharmaceutical Association (AIFA) presented his considerations on computerized systems and Inspection-Readiness especially in terms of data migration and the PSMF.

According to the Good Vigilance Practices (GVP) applied in Europe, “facilities and equipment which are critical for the conduct of pharmacovigilance should be subject to appropriate checks, qualification and/or validation activities to prove their suitability for the intended purpose. There should be processes in place to keep awareness of the valid terminologies in their valid versions to keep the IT systems up-to-date accordingly”.

This is of utmost importance in the pharmacovigilance field, especially when it pertains to the transfer of safety data from outdated or legacy systems.

What does this mean for the migration of pharmacovigilance data?

More specifically, GVP Module VI addresses the need for a quality management system to ensure compliance with standards and documentation including data collection, transfer and management.

Therefore, there is a need to establish which processes will be used in every step of data migration and who will be involved in the data transfer and their role. Next, the checks that will be carried out after migration next to be defined to guarantee data integrity and completeness in the database. Lastly, a documentation and archiving process needs to be defined.

A quality management process needs to be in place to keep track of the activities done before, during and after the data transfer to ensure that the transfer to the new database is secure and complete and that the processes used did not result in the loss of safety data.

Verifying data migration is essential when:

  • There a new safety database is implemented
  • The acquisition of a new company or the merging of two companies

As our expert points out, data migration is necessary because:

  • Cumulative data in ICSRs are requested for the analysis of signals and for a risk/benefit analysis
  • PSURs, where foreseen, must contain cumulative “summary tabulations” of adverse reactions
  • Regulatory agencies can request cumulative reviews for types of specific events
  • Occasionally follow up information can be requested for previous signaled cases

Additional Considerations for the PSMF

Besides safety databases, the PSMF must report any electronic system that collects, registers and reports safety information including medical information systems, data banks or any other system in clinical trials that collects safety data.

Common deviations for computerized systems include the absence of a disaster recovery and business continuity plan, no reconciliation between the pharmacovigilance database and other department databases and the failure to enter all AEs into the PhV database.

ARITHMOS recommends a full business and technical analysis of pharmacovigilance needs before proceeding with data migration projects. Our multidisciplinary team of business analysts, life science application specialists, pharmacovigilance system and process experts and computer system validation experts can prepare a proper user requirement analysis and a risk management plan to guide companies through data migration projects to guarantee compliance with regulatory standards.


Pharmacovigilance Practices Part I: Argus Data Migration

In this two-part blog, ARITHMOS takes an extract from its article series on migrating safety data and cases from legacy pharmacovigilance systems to Oracle Argus. ARITHMOS describes the process involved in data migration and validation principles and considerations during the production phase to ensure efficient and cost-effective pharmacovigilance practices. In Part II of this blog, coming next week, ARITHMOS will discuss what happens after migration and how joining its consortium initiative can result in considerable cost savings.

Oracle AERS premium support will end in 2015, and various other pharmacovigilance systems offer limited support. Therefore, ARITHMOS recommends a data migration project to Oracle Argus Safety, which is an up-to-date pharmacovigilance sytsem that meets all the requirements of computerized systems in the GVP environment.

Hand press on First Aid Symbol , medical background

How would an implementation project work?

As an Oracle Business Processing Services Provider (BPS), ARITHMOS provides the Oracle Argus Safety Version 7 license with payment based on cases entered in a defined time period with no annual maintenance fee. The process for migration includes:

  • Business Requirements Analysis
  • Configuration Analysis
  • GVP Validation Assessment
  • Detailed User Requirements definition (including configuration workshop)
  • Data Migration strategy
  • Configuration set-up and pilot testing system design specifications
  • Design, Build and Test Data Migration solution
  • System Installation
  • Validation Testing (IQ, OQ) and Business QC of migrated data
  • End Users training and User documentation
  • Validation Testing (PQP) and Production Data Load
  • Validation Report

This process can take an estimated 6-8 months to complete, therefore if a legacy system is still in place in your company, it is best to begin the migration process.

Due to increased regulations on safety data and the need to improve data quality, ARITHMOS can guarantee real-time reporting solutions for Oracle Argus Safety Version 7 including integration with Oracle Business Intelligence with reports directly on smartphones and tablets.

Validation Principles and Best Practices

The data migration progress guarantees:

  • Risk Based Approach
  • Proactive validation
  • Use of international standards (GAMP 5) and Internal QMS
  • Use of templates and validation scripts
  • Monitoring and control over the project
  • Multidisciplinary project team covering the key aspects of validation (business analysts, IT experts, CSV & QA specialist)

A dedicated Account Manager will provide support during the production phase including operational technical support, user access management, periodic review and support in preparation and conduction of regulatory inspections. ARITHMOS can also support in the decommissioning of the legacy pharmacovigilance system.

argus safetyIn Part II, ARITHMOS will explore what happens after data migration and how companies can properly maintain their pharmacovigilance system. If your company is considering a migration project from a legacy system to Oracle Argus Safety Version 7, schedule an assessment meeting with ARITHMOS to learn your business and user requirements.

Smart Strategies for Pharmacovigilance: Data Migration

CDV1Pharmacovigilance is becoming a more pressing issue in the drug and device cycle, mostly due to increased regulations by the FDA and EMA which are looking to increase patient safety in both clinical development and post-market use. Companies engaging in clinical development need a proper pharmacovigilance system that can manage case processing and vast amounts of data.

ARITHMOS discusses the importance of keeping systems up-to-date and the risks involved in running discontinued systems. Specifically related to pharmacovigilance and end users, ARITHMOS addresses issues associated with using Oracle AERS and Trace, two pharmacovigilance systems that will move from premium support to sustaining support (AERS 4.7 in January 2015, Trace in August 2016) meaning support services are limited and migration is recommended.

During the life cycle of a product, manufacturers produce patches to ensure security, and therefore when the life cycle of a product ends, the manufacturer discontinues full support (or in Oracle’s case, premium support). More importantly and even riskier for end users in the clinical development sector, this could put companies in danger of non-compliance with industry standards and regulations.

In the case of discontinued or outdated software, the service provider can’t keep systems up-to-date and recommend migrating to new versions or platforms.

Smart Strategy: Migrating to Oracle Argus Safety Suite

argus safetyOracle Argus Safety Version 7 is an ideal solution for managing global workflow while providing case reports and instant safety data reports and analysis. Oracle AERS premium support will end in 2015, and therefore ARITHMOS recommends a data migration project to Oracle Argus Safety. Argus Safety is an up-to-date pharmacovigilance system that meets all the requirements of computerized systems in the GVP environment. As an Oracle Gold Partner, ARITHMOS can offer Oracle Argus Safety Version 7 as well as migrate safety data from legacy or discontinued systems.

As an Oracle Business Processing Services Provider (BPS), ARITHMOS provides the Oracle Argus Safety license with payment based on cases entered in a defined time period with no annual maintenance fee. The process for migrating from a discontinued system starts with a Business Requirement and Configuration analysis through to validation testing and reports.

Due to increased regulation on safety data and  the need to improve data quality, ARITHMOS can guarantee real-time and customized reporting solutions for Oracle Argus Safety including integration with Oracle Business Intelligence.