Neurodegenerative Case Study
ARG rescues Phase I Oncology Trial Using TrialVista® CTMS
Challenge
A European biotech was previously engaged with another CRO on a Phase I Huntington’s Disease study. The company appointed was to deliver clinical monitoring and management of the ethics committee, and was also in charge of handling all communications and management relating to the exploratory trial. The main issues the Sponsor faced on the project with the original CRO were high turnover, low site support, and subpar deliverables. The challenge was to find an alternative solution, namely, to turn to another organization to rescue the project.
The Investigator on site made a specific recommendation based on a past work relationship.
Solution
An Investigator on site recommended ARG, which took over from another CRO part-way through the early-phase trial, but still successfully completed it on time and within budget. The Sponsor was able to achieve study completion on target because the ARG team provided stability, high standards, accessibility, and quality deliverables.
Creating Internal QA/QC Departments at Sites
ARG QA now engaged in creating internal QA/QC departments at the site level.
ARG continues to add new services in all areas of the organization. The latest news is that our Quality Assurance function is now engaged in creating internal QA/QC departments at the site level. Monitoring has long been considered a form of quality control; however, now that the industry is moving away from 100% SDV, it is more important than ever for a site to have an internal QC process– as well as internal SOPs and training. Compliance is evaluated through periodic internal auditing.
ARG is able to assist sites in creating internal QA/QC departments through a series of tasks:
- Evaluating existing staff through internal audits
- Conducting a gap analysis of existing SOPs and training
- Developing training programs for existing and new staff
- Creating new SOPs for QA and QC
- Reassessing staff after training and processes are in place
Moving Forward
On several other occasions afterward, ARG won other neurodegenerative study work due to investigator referrals, as building strong site relationships has always been and remains an organizational focal point.