Think Research Corporation (TSX-V:THNK) has announced that its subsidiary, BioPharma Services Inc, has continued its record of audit achievement following the successful completion of an audit by the US Food and Drug Administration (FDA) of its Toronto clinical facility for compliance with Good Clinical Practice (GCP) regulations.
Think, which is focused on transforming healthcare through digital health software solutions, said the FDA inspector, observed by Health Canada, reviewed two studies during the week of May 9, 2022, resulting in no critical findings and the issuance of zero Form 483 observations.
A Form 483 observation is a notice that highlights potential regulatory problems.
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"The positive results of the audit by the FDA are a testament to the hard work and dedication of each employee at BioPharma,” Think CEO Sachin Aggarwal said in a statement. “I commend the team for their commitment to providing a level of quality and excellence clients can depend on."
The fact that the inspection concluded one day earlier than scheduled with no issuance of a Form 483 “speaks volumes to the quality and compliance maintained by BioPharma”, the company said.
The successful results build on BioPharma's record of excellence with respect to regulatory audits conducted by the FDA. Since 2009, the FDA has conducted 13 GCP inspections of BioPharma facilities in Canada and the US without a single Form 483 observation being issued, signifying BioPharma's unwavering compliance and conformance to applicable GCP regulations, it added.
Renzo DiCarlo, president of clinical research at BioPharma said: "This latest FDA inspection truly showcases BioPharma's commitment to provide robust, valuable data to our clients. With an outstanding audit record spanning over 13 years, I'm so very proud of our Think Research Family."
Think noted that BioPharma is leading the digitalization of the clinical research industry with its award-winning facilities in Toronto, Canada and St Louis, US. Earlier this year, the subsidiary announced the launch of its clinical trial Electronic Data Capture (EDC) platform, which expedites Phase 1 clinical trial timelines, improves access to data for sponsors, and enables clients to shorten their drug development timelines to get therapeutics to the market faster.
"This latest inspection exemplifies BioPharma's consistent focus on quality throughout the clinical trial process,” stated Jo Ann Di Sensi, vice president for global quality and privacy officer at BioPharma. “With over a decade of successful inspections by the FDA, as well as other leading regulatory bodies such as Health Canada, Standards Council of Canada, EMA (ANSM & DKMA), UK MHRA and ANVISA, BioPharma continues to be a partner of choice for innovative Phase 1 development programs.”
Think Research is an industry leader in delivering knowledge-based digital healthcare software solutions. The company's focused mission is to organize the world's health knowledge so everyone gets the best care. Its evidence-based healthcare technology solutions support the clinical decision-making process, standardize care, and improve patient outcomes.
Contact the author at stephen.gunnion@proactiveinvestors.com