An Expanded Audit-Ready Quality System

SITUATION

An academic research organization (ARO) with rapidly increasing service offerings needed to expand their quality system, ensuring it would withstand sponsor and regulatory authority scrutiny. Halloran had previously delivered 11 Standard Operating Procedures (SOPs) and 14 supporting forms and templates, all of which had undergone a sponsor audit with zero findings. The expanded system needed to control activities for supporting IND clinical trials, including delegated sponsor obligations.

SOLUTION

  • Over the course of 6 months, Halloran created 15 SOPs and 34 supporting forms and templates and updated 1 SOP.
  • The expanded quality system integrated seamlessly with the current system and aligned with the policies of the larger academic/medical organization of which the ARO is a part.

VALUE

The company’s expanded audit- and inspection-ready quality system included newly added service offerings, which prepared them to compliantly and efficiently implement activities on behalf of their sponsors.