The subsidiary has seen stellar audit performance results of zero Form 483s since 2009
TORONTO, June 16, 2022 /PRNewswire/ – Think Research Corporation (TSXV: THNK) (OTCQB: THKKF) (“Think” or the “Company“), a company focused on transforming healthcare through digital health software solutions, is pleased to announce its subsidiary, BioPharma Services Inc., (“BioPharma“) has continued its record of audit achievement following the successful completion of an audit by the United States Food and Drug Administration (the “FDA“) of BioPharma’s Toronto clinical facility for compliance with Good Clinical Practice (“GCP“) regulations.
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.1 The fact that the inspection concluded 1 day earlier than scheduled with no issuance of a Form 483 speaks volumes to the quality and compliance maintained by BioPharma. 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.
BioPharma is leading the digitalization of the clinical research industry with its award-winning facilities in Toronto, Canada and St. Louis, USA. Earlier this year, BioPharma 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.
Jo Ann Di Sensi, VP Global Quality and Privacy Officer at BioPharma said, “This latest inspection exemplifies BioPharma’s consistent focus on quality throughout the clinical trial process. 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.”
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.”
Sachin Aggarwal, CEO at Think said, “The positive results of the audit by the FDA are a testament to the hard work and dedication of each employee at BioPharma. I commend the team for their commitment to providing a level of quality and excellence clients can depend on.”
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. For over a decade, Think’s cloud-based, EMR-agnostic digital tools have empowered clinicians around the world and positively impacted millions of patients across the continuum of care – including primary physician care, acute care hospitals and surgical suites as well as community and seniors’ care. Think is proud to serve as a trusted health system partner to a rapidly growing, global client base that spans five continents across more than 13,000 healthcare facilities, with a clinical audience of over 300,000 doctors, nurses and pharmacists. Visit: www.thinkresearch.com
BioPharma Services Inc. is a full-service Contract Research Organization (CRO) specializing in the conduct of Phase 1/2a and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma Services has clinical research facilities both in the USA and Canada with a total capacity of 300 beds with access to healthy volunteers and special populations. Headquartered in Toronto, Canada, BioPharma’s comprehensive services also include Bioanalysis at our GLP Certified Laboratory, Scientific and Regulatory Affairs, Biostatistics and Safety Data Analysis (CDISC), Data Management and Medical Writing.
For more information about BioPharma Services, contact Ms. Anna Taylor, EVP of Commercial Operations at [email protected]
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
For more information: https://www.thinkresearch.com/ca/investors/
An FDA Form 483 is issued at the conclusion of an inspection when an Inspector(s) has(have) observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. Observations are made when in the Inspector’s judgment, conditions or practices observed would indicate that any food, drug, device, or cosmetic has been found deficient e.g., inadequate subject protection, inadequate accountability for the investigational product, failure to conduct or supervise the study in accordance with the relevant protocol (s).
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SOURCE Think Research Corporation