Our Proven Process
Our Proven Process is made up of five core components that enable us to fully understand and support our clients in adverse event management and post-market regulatory compliance. Prior to starting services as a SafetyCall client we carefully determine our clients’ needs and guide them through implementation. As a SafetyCall client we provide unmatched professional leadership and expertise in delivering total solutions for human and animal adverse event management, regulatory compliance and post market surveillance. We are committed to our clients’ success and driven to provide them with a superior experience providing ongoing support and surveillance.
Discovery and Client Needs
We start by listening to our clients to fully understand their service needs. We then determine how our services align with those needs to provide them with a total solution.
Proposals and Agreements
From there, we submit a proposal for review that details the services that we will provide. Upon agreement the proposal becomes an exhibit and a master service agreement contract is fully executed.
Implementation
Once the Master Service Agreement has been executed, we move into the onboarding and implementation phase. We work with you side by side to ascertain and complete all the information needed to go live as a SafetyCall client.
Medical Contact Center
Once complete, the medical contact center and regulatory compliance work begins. The medical contact center is a combination of incident management, adverse event documentation, assessment, and on-going surveillance. At this time, our clients are also provided with a dedicated SafetyCall client liaison, who is their direct communication line for questions and feedback.
Regulatory Compliance
We support our human and animal industry clients in their regulatory reporting obligations to several government agencies in the United States and Canada. FDA, EPA, CPSC and Health Canada.
Ongoing Support
In addition to a client liaison, we have a detailed ongoing support plan that includes quarterly check-ins and summary reports, an annual meeting, daily case notifications, and a client database portal where incidents documented by SafetyCall can be accessed at any time.