Clinical Process Roadmap

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. They wanted a mechanism to organize the procedures into a useful job aid which would be used globally.
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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.
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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.
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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. No experience in regulatory affairs to understand the dynamic nature of regenerative medicine interactions with FDA.
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