Last week's blog post discussed the importance of understanding what adverse events are reportable to FDA and how they are submitted. This week we discuss Best Practice #2: Take control of your software.
Processing and managing safety issues is complex. This complexity is often heightened with the involvement of multiple technology vendors in different stages of the process. That confusion and complexity is compounded when the vendors rely on outdated software or unwieldy Excel spreadsheets.
Pharmacovigilance professionals and biopharma executives should understand the importance of maintaining oversight on the drug safety processes. Executives need to provide drug safety departments with the tools they need to properly manage safety issues and protect corporate interests and shareholder value.
Outsourcing pharmacovigilance technology operations has long been a cost-effective way of achieving regulatory compliance. The scale that a technology vendor can operate at makes sense with the historically high cost of drug safety dedicated data warehousing, software, and in-house human resources. However, new cloud-based software-as-a-service (SaaS) options in the pharmacovigilance software market empowers even the smallest Drug Safety departments in the earliest stage companies to take advantage of modern technology. Forward thinking companies use these new software options to take back the technology aspects of pharmacovigilance from their vendors. This saves costs, establishes a foundation of operational success, and eliminates significant risk.
The most important software that any drug safety department can retain is for signal management. Accurately tracking all activity that relates to a potential safety case, creating standard workflows for issue review, and documenting adjudication decisions can help to ensure the right people within an organization are making the right decisions, at the right time.
Until recently, this has meant either expensive, resource intensive, and complicated software or unwieldy spreadsheets and SOPs. New cloud-based SaaS options now exist to manage safety issues in a GVP IX compliant way that can fit into any budget, are validated and implemented in a few short weeks, and create a foundation of pharmacovigilance operational success that will be carried through all phases of development and into post-approval needs.
Can't wait for Best Practice #3? Download the white paper, Pharmacovigilance Best Practices for Clinical and Early Post-Approval Biopharma.
Interested in signal detection best practices? Read Pharmacovigilance Signal Detection: A Complete Guide.