Cetero expands its TDDS and clinical dermatology services

Now the contract research organisation (CRO) can conduct custom-designed studies in the two areas in its Miami, St.Louis, Toronto and Fargo facilities.

The firm also offers a higher level of preclinical analysis with the addition of two MicroMass LC/MS/MS systems to complement its current four LC/MS and four LC/UV and GC/MS systems.

Cetero says the new technology gives it the capabilities to evaluate the in vitro​ dermal absorption of the most challenging compounds currently in development or production.

Alan Copa, president of clinical operations in the Fargo facility said: “The ability to offer custom-designed studies and work as a true partner with study sponsors sets Cetero apart as the leader in dermatology and transdermal applications.”​

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It will also allow its pre-clinical dermatology research laboratory to further expand its ability to conduct testing of in vitro​ percutaneous absorption and semisolid release to GLP standards, including analytical method development and validation.

Copa added: “Our team understands how critical factors such as dose application and removal, skin conditions and diseases, lifestyle history and adverse event assessment (skin and systemic) will impact how the skin absorbs a compound, assuring the design of studies to control for those details.​

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“This understanding, combined with our advanced technology, allows our integrated team of dermatology experts to seamlessly leverage their knowledge into the design and performance of clinical trials.”​

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Smooth run​

Cetero also says that its extensive collaboration with the FDA, the US Pharmacopeia and other international agencies should make regulatory approval less taxing.

In fact the company has gone beyond recent FDA guidance for transdermal delivery systems, which recommend that at least two “climatically different sites”​ should be used for assessing patch adhesion performance, and irritation and sensitization potential.

The North Carolina-based CRO has spread the study processes across all four enhanced sites, with what it says is “the same protocol and comprehensive final report within one full-service package.”​

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Copa added: “All studies at Cetero can be performed to FDA, International Conference on Harmonisation (ICH), European Medicines Agency (EMA) and Organisation for Economic Co-operation and Development (OECD) specifications as needed to facilitate regulatory approval.”​

Ongoing investigation​

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Cetero’s efforts to emphasise its compliance with regulations is understandable given that it is currently the subject of an FDA investigation.

In July, sponsors were faced with the prospect of re-doing their lab work after the FDA accused the company​ of faking records, and manipulating lab samples to meet approval criteria.

The alleged transgression was announced publically after the firm’s Houston facility received unsatisfactory responses to two 2010 investigations.

The investigation was first flagged up by Cetero themselves, after an employee raised formal allegations of regulatory violations in 2009.

However, the employee claims to have first reported wrongdoing in a meeting back in June 2007.

The results of the investigation are still pending.