Medical Device CRO Aims at Improving Outcomes of FDA Clinical Audits

Alquest: '2009 regulatory wisdom is largely useless today'

MINNEAPOLIS--(BUSINESS WIRE)-- Medical device CRO Alquest has launched a new support service aimed at helping medical device manufacturers anticipate, prepare for and respond to new and unpublished FDA standards being applied to biomedical research monitoring inspections and audits.

Clinical standards and practices that medical device manufacturers believed to be true and reliable as recently as a year ago are significantly outdated, according to Alquest President Ann Quinlan-Smith.

Alquest’s rigor and thoroughness in investigational site monitoring, record keeping and data management were validated following a recent week-long FDA sponsor audit at the firm’s Minneapolis location.

“We also have participated in six BIMO field inspections by FDA in the last six months and we’ve found that scrutiny by FDA’s Office of Compliance is significantly different and more thorough than before,” said Quinlan-Smith. “Many manufacturers are being blindsided by these requirements. In essence, 2009 regulatory wisdom is largely useless today.”

Having supported more than 500 medical device manufacturers in its 17 years, Alquest is extending its “fresh” FDA audit experiences to customers by providing insights during 510(k) or PMA pre-market application review. Alquest has noted major changes in FDA interest and audit focus, including areas such as:

  • Study design
  • Protocol deviations (many new twists)
  • Investigative site qualification/selection/training
  • Source documentation
  • Device accountability
  • Clinical SOPs

In 2010 Alquest trained or retrained its entire staff of project managers, clinical research associates and clinical monitors to contemporary FDA audit practices and requirements. As part of the firm’s continuous improvement efforts, Alquest also launched its own internal clinical quality initiative to enhance consistency and repeatability of processes and practices.

Medical device firms about to design an IDE clinical study, in mid-study, or about to file a 510(k) or PMA pre-market application are well-advised to consider the “new normal” of FDA clinical requirements, says Quinlan-Smith. “The downstream cost of attempting to retroactively fix problems is substantial. Alquest has fresh, valuable insights that can save manufacturers and investors considerable time and money.”

Alquest LLC – a NAMSA Company
Alquest LLC is a NAMSA company. Founded 17 years ago, Alquest provides medical device manufacturers support in the areas of regulatory strategy and submissions; clinical trial design and trial conduct; quality systems; and product safety, biocompatibility and sterilization. NAMSA is the world’s leading medical device-focused contract research organization specialized in safety evaluations. For more information, see and


Alquest LLC
Tom Huyck, +1 763-287-3830
Vice President – Business Development
Email: [email protected]

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