Pharmacovigilance Case Study
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Effective changes to managing Drug Safety data
We will always endeavour to bring solutions to the table in a timely manner, rather than simply sit back and try to fix problems when they occur. The following case study describes how PDS’s client benefited from our forward thinking, pro-active and collaborative approach to working with our clients in outsourced pharmacovigilance.
In 2013, PDS entered into a collaboration with a large generics company to manage two key areas of pharmacovigilance: Clinical Spontaneous Adverse Events capturing and Post-Marketing Surveillance.
The client required a fully outsourced pharmacovigilance service for both their established portfolio of generics and for Clinical Trials. The outsourced service included:
- Responsible Person (RP)
- QPPV and Deputy
- Adverse Event Management – processing and review of all cases
- Weekly literature searches and Signal Detection
- Risk Management
The client provided PDS’s team with access to its incumbent spreadsheet based system to manage these critical data; however our team quickly identified there were a number of fundamental issues that created potential risk for the client.
Together these factors impacted negatively on overall efficiency of case management and processing and it was imperative to overcome all related key issues to both mitigate risk of non-compliance and to reduce operating costs for the client.
The PDS team compiled a list of key issues brought about by the client’s incumbent spreadsheet system and then worked closely with the client to assess the associated risks. By working collaboratively, PDS and the client were able to define a set of key objectives for improvement moving forward, which aimed to deliver:
- A more structured and efficient system for managing critical PV data
- Improved stability and security
- Improved quality control
- Greater transparency
- Improved business continuity
It was paramount that the above objectives supported the entire lifecycle of case management, whilst improving quality control and operating efficiencies.
Having thoroughly considered all of the key issues directly associated with the existing spreadsheet system PDS recommended the client implemented a fit-for-purpose, structured electronic Drug Safety Data management system.
In implementing the system recommended by PDS, the client would be able to overcome all of the associated issues and meet its required objectives moving forward.
Another key element within the project was to ensure continuity, i.e., that all legacy data were successfully migrated into the new system for ongoing management of open cases, future reporting and historical analysis.
Following agreement of the proposed solution with the client, the Drug Safety management system was implemented in a secure environment and validated using GAMP 5 standards. The system was also compliant with 21 CFR Part 11 standards for the use of electronic signatures.
The clients’ legacy data was migrated from the existing spreadsheets into the Drug Safety Management system to create a core database, before being rigorously tested against the ‘live’ reference data to ensure it was complete and consistent. Following successful testing, the system was made live and the original spreadsheet system was archived.
PDS helped its client meet all of its objectives, through the implementation of a fit-for-purpose, compliant Drug Safety Management system at an affordable cost.
The ongoing (tangible) benefits to the client include:
- Reduced risk through improved security through unique user ID and login
- Improved quality control through secure audit trail of any changes made
- Improved efficiency of PV service processes through using a structured database system
- Reduced operating costs through eliminating task duplication and minimising downtime
- Improved transparency through automated and flexible on-board reporting
- Assured business continuity (for PV services) provided by stringent database back up procedures
- Ongoing compliance through vendor updates aligned with regulatory changes.
The client continues to benefit from the implementation of the structured electronic Drug Safety Data management system. As the client’s business (and portfolio) continues to grow, the solution implemented by PDS is able to grow in-line with it.
Today PDS continues to work successfully alongside the client using a collaborative TEAM approach.
This project brought PDS’s vast PV knowledge and experience into play, enabling us to help our client achieve its objectives. Using our TEAM’s combined experience of a wide range of Drug Safety Management systems, we were able to match the client’s needs to the right system, not only in terms of what was right for them at them at the time, but what would continue to deliver to their needs in coming years.
Carol Kingstone, Managing Director PDS