Situation:
An academic research organization (ARO) with rapidly increasing service offerings, including support of IND clinical trials, was in need of a quality system that would withstand Sponsor and regulatory authority scrutiny.
Solutions:
- In less than twelve weeks, Halloran developed a quality system of 11 Standard Operating Procedures (SOPs) and 14 supporting forms and templates.
- The quality system was created in alignment with the policies of the larger academic/medical organization of which the ARO is a part.
- Halloran delivered instructor-led training on the final, released documents to all relevant members of the organization.
Value:
The client received a quality system that was ready for Sponsor audit and project implementation. Training provided an opportunity for questions and discussion about practical application of the processes. The client subsequently asked Halloran to create additional quality system documents for newly added service offerings.