The very basis of pharmacovigilance is to detect, collect, monitor, and assess reports on adverse events from drug and biologic products. These reports can range in severity but all aim to support one thing – human safety. The distribution of safety event reports to investigator sites, ethics committees, and Institutional Review Boards (IRBs) can be challenging.
It’s become increasingly difficult for pharmacovigilance teams to effectively track adverse events and distribute reports globally. The growing globalization of clinical research means that pharmacovigilance teams are tracking adverse events across more geographies and reporting channels than ever before. At the same time, pharmaceutical manufacturers are introducing more specialized drugs and investigational products to the market, which creates new unknowns for potential adverse events.
This has resulted in unprecedented growth in the total number of adverse event reports received by the US Food & Drug Administration (FDA). From 2011 to 2021, the number of reports grew by nearly 200% with analysts projecting global pharmacovigilance spending will grow at a compounding rate of 11.5% from 2021 until 2028.
The growth in adverse events puts tremendous strain on clinical operations and pharmacovigilance teams in both sponsor and CRO environments. Most notably, large sponsors or CROs with manual processes. Traditional processes that rely heavily on manual processes are labor-intensive and prone to human error—not to mention, they’re slow. All of these challenges add up to risk and unneeded effort.
Technology can help automate much of the safety document distribution processes, speed the handling of adverse events, reduce costs, improve patient safety, and unlock growth opportunities alongside compliance. While this is reason enough for organizations to add a safety document distribution solution, it’s prudent to explore the other reasons why it makes sense for organizations to move to an automated system.
Reason #1: Remove or Reduce Unnecessary Manual Processing
The traditional manual process is very time- and labor-intensive. As adverse events are experienced, teams must assess and determine if the event qualifies for expedited reporting. If it does qualify, the next thing to do is to manually collect reports from pharmacovigilance. Once the reports have been received and collated, a dedicated team must select all relevant studies, investigators, IRBs, and ethics committees for distribution which can be a very cumbersome task when done manually.
From there, the team is responsible for preparing reports such as CIOMS and MedWatch, as well as corresponding cover letters. The cover letters are often personalized and require extra time to source the appropriate addressee. Once the reports are prepared, the next step is to distribute the collated reports and any other pertinent information via email, mail, fax, or web portal.
When teams are working manually, managing distribution can be especially cumbersome and complex because it is accompanied by so many tenuous steps. Before distributing reports, teams must ensure they have the correct mailing or email address and that the information on the cover letter is correct and up to date. Email addresses, fax numbers, and mailing labels all need to be verified to ensure these sensitive reports are going to the right place and are being properly tracked. In addition to distribution, teams are responsible for maintaining distribution records. These records are crucial for not only tracking what was sent where and to whom, but also to maintain compliance and ensure that teams are hitting their distribution deadlines. For CROs, the distribution records are especially important to provide proof of service to their sponsors. Yet, many clinical teams still rely on spreadsheets to track this critical information.
As you can see, that is a lot of steps that open you up to a plethora of challenges when managing this manually. A safety document distribution system that leverages automation alleviates much of the burden felt by clinical teams as it lifts much of the manual labor involved in distributing reports needed by pharmacovigilance and clinical teams. It also replaces the need for risky spreadsheets by aggregating all reports and tracking information in a singular place.
By leveraging automated in-app triggers and allowing for quick access to distribution lists and site information, this solution can accelerate the distribution of reports while minimizing risk.
Reason #2: Strengthen Compliance Efforts with Regulators
Regulations are an expected part of drug and therapy development but the increased oversight that affects the life sciences industry creates an added layer to research and development. Compliance becomes a critical problem when an audit or inspection takes place and CRO/Sponsor cannot show that they distributed the expedited report based on defined timeframe. Investigators, ethics committees, and international review boards need to quickly be able to understand a situation and its possible impact on patient safety. By having a software-based safety document distribution solution that leverages automation, organizations can have a consolidated, traceable system where report receipts and acknowledgements can be tracked. Why does this matter? Providing a traceable document flow and acknowledgement reports, organizations can help organizations be ready to share documentation in case of audit or inspection. And for CROs supporting their sponsors customers, this added layer of oversight will come as welcome news as the sponsor is ultimately responsible for compliance.
Reason #3: Distribute Safety Reports in Real-Time
Report distribution can be a lengthy process when leveraging outdated systems like paper mailing. The result is your teams investing a significant amount of time in report distribution, coupled with the rising increase in adverse events that require report distribution and you’re diverting attention from other areas that could benefit from your highly specialized staff.
By having a safety document distribution system in place, reports are quickly made available to all stakeholders and distributed to set mailing lists. Solutions like LifeSphere Safety Document Distribution allow your clinical operations or pharmacovigilance teams to easily share reports rapidly via email, web portal, fax or mail. By reducing the latency in report distribution, clinical and pharmacovigilance teams can enable real-time safety document distribution which can keep the organization compliant.
Reason #4: Automation Allows for Improved Oversight
Alerting teams of adverse effects or other potential complications in real time allows organizations to better provide the oversight needed immediately. As a result, clinical operations or pharmacovigilance teams can address issues quickly. An automated system allows teams to focus when and where attention is needed rather than spending large amounts of time manually pulling together all that is needed to distribute the report, a process that could lead to errors.
In short, every step of the drug development cycle then becomes more efficient, more effective, and, ultimately, aids the organization in controlling cost and the ability to overcome obstacles to market.
Reason #5: Realize the Cost Savings
The undertone of safety document distribution systems is undoubtedly the cost-efficiency of the solution. Drug development is expensive and has a steadily decreasing profit margin, thus, organizations want to control costs early to maximize profit. Making teams more efficient through automation and reducing the manual workload is beneficial for everyone, empowering employees and reducing organizational costs related to labor and mailing, to name a few.
Although the quantity of adverse events continues to grow year over year, many teams continue to rely on heavy manual processes throughout the adverse event lifecycle. Without automation built into these processes, they can become riddled with inefficiencies and subject to human error. Adding a solution such as LifeSphere Safety Document Distribution is an investment case that supports organizational interests. At its core, LifeSphere Safety Document Distribution makes it so a smaller and nimbler team can focus on the work that matters most – benefiting humankind. Want to learn more? Request a demo to talk with our team or watch our webinar on this subject!
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