Building Up Client's Quality Infrastructure-Building Up Client's Confidence in their Ability to Meet Industry's Expectations.

We were hired to help a start-up company get ready for the launch of clinical studies with their first client. At the time of the initial discussion, we suggested a number of steps that would help our client to meet the challenges associated with the auditors' expected scrutiny. The proposal was approved by our client, and a number of documents were sent for our review to enable us put a Project Plan in place, as the Work Order stated.

In the process of preparing the approved deliverable, we saw an opportunity to circumvent multiple steps within our proposal and provide our client with a much more valuable deliverable. The deliverable was a "Gap Analysis" document, which identified activities, processes and documents that were supposed to be in place in order to support the client's client. In addition to that, we identified multiple legal issues and logical gaps in the workflow that needed further clarification and follow-up.

So, for the initially agreed to budget and within the initially committed-to timeframe, we delivered a "roadmap" that outlined the compliance and operational deficiencies that needed to be fixed, and practical remedies. Try to top that!