Development of Clinical Quality Management Systems: Istesso

The Challenge

Istesso (formerly Modern Biosciences) approached Aptus Clinical to review and update their standard operating procedures (SOP) prior to undertaking the First in Human (FiH) study for their lead project

The Solution

Aptus Clinical identified a clinical process expert to undertake a comprehensive review of existing SOPs and to make recommendations for modifications and/or creation of new processes

The Outcome

A fit for purpose SOP infrastructure was put in place to support the clinical testing of their lead asset

The Feedback

Istesso was pleased with the work we did and have recently requested Aptus Clinical to undertake a similar review to support their Phase II testing

Client Feedback

The task was completed to a high standard, on time and in budget with the Aptus expert demonstrating an excellent understanding of the area whilst being flexible and responsive to our needs. She also built a great rapport with our staff making the whole process easy and straight forward

Sam Williams, CEO , Istesso