Clinical Process Roadmap
Case Study
A global medical device company with clinical operations staff in multiple locations that had grown through acquisitions wanted to harmonize their SOPs into a single repository.
Development Strategy Used for Fundraising
Small virtual biotech start-up with stem-cell therapy treatment for HIV. Strong scientific expertise but limited experience in moving research phase work into early clinical (pre-IND) development.
Quality Systems Gap Analysis and Remediation
A market leading medical device company with a robust pipeline of Class II and III surgical devices recognized challenges in quality and delivery in their clinical organization and requested an organization-wide gap analysis.
Clinical Monitoring Oversight Toolkit
A biotech company elected to outsource their clinical study monitoring. As a result, the company needed a toolkit for internal use to evaluate and monitor the quality of the outsourced monitoring effort.