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Regulatory Affairs Activities

The regulatory teams within an organization are a shared service group. As a shared group, their work schedule is dependent on the workflow of the internal teams they serve as well as the external site locations used by the clinical trial. The following case scenario illustrates the difficulty of monitoring progress by multiple teams.This scenario is an example only, and is not meant to be a complete overview of the entire regulatory affairs process.

Scenario. Regulatory teams are shared by many groups and/or departments within an organization. Because they are a shared service organization, scheduling their time as needed is a challenge. The regulatory team may also use as many as 20 different tools to record their reviews.

The Process. There are many stages in the testing and development of a drug. Each stage is reviewed by the regulatory team using a variety of tools. And because the regulatory team is further upstream in the testing and development process, scheduling the team is dependent on timely workflow of the previous activities.

The Problem. Even though each stage of the drug lifecycle is managed and monitored, there are numerous areas where communication, handoffs and administrative glitches can create havoc in the workflow and cause schedule delays. Because regulatory activity follows testing, these delays are critical to scheduling, and if proper notice is not received and planned, the regulatory team may not be able to be deployed on time.

The regulatory team may use as many as 20 different tools to review a process. This lack of uniformity makes it harder for the FDA to review submissions, which in turn can cause delays, and possible rejection.

The Solution. DLTA provides a structured approach to regulatory affairs. Status reports are visible by all involved, and alert notifications are distributed when there are any delays or breakdowns in the process.The application tracks each phase of the drug lifecycle, making it easier for regulatory teams to anticipate when their services will be needed. Regulatory teams also perform reviews using the tools available within DLTA, which allows for consistent documentation throughout the process.

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