Regulatory Submission Crisis Rescue: When And How To Take Action

By Jenny Minigh, inSeption Group

Clinical trial rescue is a common service in the industry. It happens when a clinical trial encounters substantial obstacles that jeopardize its on-time completion and adherence to Good Clinical Practices. In an attempt to preserve the trial’s integrity, the pharmaceutical/biopharmaceutical sponsor may call on a vendor to provide the experience and expertise necessary to resolve issues and rescue the trial from certain doom.

Meanwhile, regulatory submission crisis rescue is a similar situation that pertains to regulatory submissions instead of clinical trials. Few organizations have expertise in submission crisis rescue, so it can be difficult for sponsor companies to know whom they can turn to for help, or even when it is time to seek such assistance.

It also must be acknowledged that submission crisis rescue is not an overnight fix. Each rescue plan must be individually tailored to the client’s specific situation based on its available resources, timelines, the type and extent of its problems, and more. Corrections to underlying problems that prompted the need for a submission crisis rescue cannot be cosmetic; they must be well-informed, thorough, and sustainable.