FDA Cites Cliantha Research on Data Integrity, Quality Unit
FDA investigators cited Cliantha Research Ltd, a contract research organization in Ahmedabad, India, over data integrity, documentation and clinical research deficiencies following an inspection conducted 4/13-17. The agency issued a four-page Form FDA 483 to the company documenting six inspectional observations at Cliantha's bioanalytical and clinical research facility, with the most significant findings centered on the firm's handling of bioanalytical study data and quality oversight.
FDA said Cliantha failed to consistently investigate significant variations in internal standard (IS) responses across multiple studies, despite procedures requiring such investigations. Investigators said the company did not examine an apparent inverse correlation between analyte and internal standard responses in certain studies while conducting investigations in other studies with similar issues.
The agency also cited the company for failing to maintain complete contemporaneous source documentation. Investigators found that details of sample transfers between laboratory freezers had been recorded on scrap pieces of paper that were later discovered in trash cans. According to FDA, the information was subsequently transcribed into official freezer logbooks, meaning the logbooks were not the original source documents. Similar deficiencies involving undocumented sample transfers were identified for additional studies.
Another observation alleged that Cliantha could not adequately account for missing sample volumes in several bioanalytical studies. FDA documented multiple instances in which portions of biological samples were unavailable for incurred sample reanalysis, and investigators said the firm could not explain what happened to the remaining sample volumes. The agency also cited inaccurate reporting in one bioanalytical study after documentation indicated aliquot samples had been used despite the final report stating they had not.
FDA further criticized the firm's quality unit, alleging it failed to perform adequate laboratory investigations of analytical events and deviations. Investigators said laboratory events were investigated and concluded by analysts without quality unit management review, approval or oversight. The Form 483 cites several examples involving chromatographic runs that produced missing responses, shortened run times and low peak responses, where analysts conducted informal investigations and implemented corrective actions without documented quality unit approval.
The inspection also identified a clinical research deficiency involving informed consent. FDA said legally effective informed consent was not obtained because the site's general screening consent form did not describe certain study-specific procedures. According to the agency, mammograms, transvaginal ultrasounds, Pap smears and estradiol plasma concentration testing were performed on 48 enrolled subjects before they signed study-specific informed consent documents.