The Case for a Cloud-Based Safety Letter Notification System

By Mike Demo, Director Professional Services, Trifecta Clinical

In recent years, greater scrutiny has been placed on identifying and reporting of safety events that arise during the drug development process. Led by Congress and the FDA, this scrutiny signals an increased focus on the proper exchange of information between sites and sponsors executing clinical trials. For sponsors, the complexity and burden associated with global distribution and country specific regulation causes not only great frustration, but is often email based and exceedingly manual, in other words, ripe with possibility for error. When viewed from the perspective of investigative sites, the burden is often beyond comprehension, where overdistribution can cripple productivity and take focus from other critically important aspects of the trial itself. Considering this, the case is clear – innovation is needed to solve these complexities at speed without compromise, to deliver more trial with (far) less error.

Below summarizes my experience with innovation in the area of a cloud-based safety letter notification and my take on the benefits and most significant results clients see.

More Regulatory Control

As global regulatory requirements change, complexity is constantly infused into Pharmacovigilance processes. As a solution to this, a cloud-based solution facilitates the development of global notifications based on each country’s unique regulatory requirements alongside the proper regulatory teams. This strategic step ensures the solution can be automated to an exacting standard. Meaning, the right notification is delivered to the right site, region, country, investigator, and study team—at precisely the right time.

Less Administrative Burden

This applies to both sponsors and CROs in addition to the sites they serve. For sponsors and CROs, we see dramatic reductions in administrative burdens placed on PV and clinical operation teams. Ensuring accurate safety notifications is simply table stakes. With our SafetyVigilance solution, all Safety Notifications, SAEs, SUSARs, Investigator Brochures and Dear Dr. Letters are not only delivered, but tracked, with automated confirmation of acknowledgement. This ensures safety notifications are crystal clear across the enterprise, allowing clinical teams to know exactly which events require follow up. For sites, workload burdens associated with over distribution are kept in check while the system simultaneously ensures audit proof record keeping.

More Compliance

One of the highlights of my career with Trifecta has been working with sponsors and CROs to achieve improvements in compliance that are not just significant, but game changing. The virtuous circle of strategic regulatory requirements, feeding automated delivery, and ensuring site acknowledgement allows for dramatic increases in compliance rates. A recent implementation has yielded a 3X increase in enterprise compliance at a Top 20 pharmaceutical sponsor in less than 18 months. This increase in compliance in turn creates even less administrative burden, more visibility and a highly energized team – from the PV team to the C-suite.

Less Cost

The results described above also lead to another type of win, cost savings. In the interest of total transparency with our clients, Trifecta uses a risk-based cost model. Meaning that payment is made only for safety letters distributed which places the shared focus on performance. Short term, overhead costs can be cut dramatically. Longer term, the increase in compliance from automation decreases risk of audit findings, resulting in more peace of mind throughout the drug development process.

Of note, Trifecta believes in simplification, unification, and process improvement. If integrations with other systems will deliver results to our clients, we will build them.

Please reach out to me at mike.demo@trifectaclinical.com to learn more about SafetyVigilance and how I can replicate these results for your team.