Note: The Skinny blog is written by Rick Smith, editor and co-founder of WRAL Tech Wire and business editor of

RESEARCH TRIANGLE PARK, N.C. – Imagine you are an executive at a relatively small but growing company in the extremely competitive, closely regulated life sciences services business and your firm is under investigation by the Food and Drug Administration.

You’re David against Goliath. One blow from Goliath and you might be out of business.

You have already reported violations found during an internal investigation to the FDA; you’ve changed your management and fired employees as a result. You’ve opened doors and records to FDA investigators. As you wait for 18 months to hear what the FDA has decided to do – if anything – a fax shows up unannounced from Goliath that lowers boom. (Read story here.)

The FDA then issues a press release and other documents on its website with international media reporting that your firm is in trouble. Big trouble. (Read here and more here.)

So, what do you do?

David is Cetero Research, based in Cary with seven operations across the U.S. and Canada and just over 1,000 employees.

The reaction is careful.

First, you reach out to clients and partners.

Second, you begin telling your side of the story. A letter is issued to an inquiring news outlet seeking comment in order to begin telling your side of the story. (Read post here.)

You say: The FDA action “discredits” Cetero and its employees.

You add: “The Untitled Letter does not accept the results of our rigorous scientific analysis and discredits the Company’s 1,200 dedicated and experienced employees,” the company wrote. “The research conducted on behalf of our pharmaceutical sponsors can be, and has been, properly validated.”

Third, after a board meeting, you begin crafting a response to the FDA broadside that respects the FDA’s authority.

Fourth, in response to questions submitted via e-mail from a media outlet, you outline the steps the company has already taken to remediate the problems discovered at a lab in Houston.

“Cetero fully supports and respects the FDA’s mandate to ensure that all approved and marketed drug products are safe and effective,” Cetero says in responses to questions from WRAL Tech Wire. “We want to work with the Agency to resolve this. We will resolve the issue through the FDA’s process, providing transparency to our clients on the progress of follow up actions.” (Read more here.)

As David, you show respect for Goliath and pledges cooperation.

How will Goliath respond?

For the time being, you can only wait.

How would you like to be in the sandals of Cetero CEO Troy McCall and his employees?

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