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Todd Kisner

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Todd Kisner
Todd Kisner
Vice President, Quality & Regulatory Affairs

Todd Kisner is a recognized clinical research industry senior executive with more than 20 years of experience in the pharmaceutical and technical industries. As the Vice President, Quality Assurance and Regulatory Compliance, he oversees the Corporate Quality Management System, Regulatory Compliance and Records Management groups at Bioclinica. He holds responsibility for ensuring Bioclinica and its products and services comply with international regulatory standards, industry best-practices and leads retrospective oversight activities. Todd has held numerous positions of increasing responsibility and joined Bioclinica as the Vice President of Quality and Regulatory Affairs in 2013. Prior to joining the Company he was responsible for Quality Assurance and Regulatory Compliance with CoreLab Partners and the Director of Quality Assurance with Medifacts International. Todd has held key validation and technical roles at SAS Institute and Thomson Reuters. Additionally he has been a contributor to the Metrics Champion Consortium for both ECG and Imaging, and has extensive experience in data privacy regulation, 21 CFR Part 11, GxP, Quality Assurance, SDLC and Validation Services. He holds an organizational excellence ASQ certification and sits on industry Global Data Protection and Privacy Committees, Ethics & Regulatory Compliance Committees, and GCP Quality Management System work streams.

Blogs

Many questions still remain several years after the July 2012 ODAC (Oncologic Drug Advisory Committee) Meeting on the "Evaluation of Radiologic Review of Progression-free Survival in Non-Hematologic Malignancies." Further investigation was recommended into the utility of taking an audit approach (central reads of a test sample) to identify potential bias in the local evaluation (LE) of patient

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Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

Bioclinica Delivers Individual Case Safety Report (ICSR) Processing w Quality & Consistency While Crossing One Mil… https://t.co/77NOME2Dj7
bioclinica (21 hours ago)
Who made the BioSpace list of 11 most innovative life sciences companies in the world? Ck it out here via @biospace… https://t.co/f9vtRpsbMW
bioclinica (Yesterday)
BREAKING: With a passion for Drug Safety, we’re delighted to share @bioclinica #pharmacovigilance crossed 1M ICSR c… https://t.co/PAdROjo7tE
bioclinica (Yesterday)
RT @isciencebox: Draft and Final FDA Guidances Detail Development of New Drugs for Neurological Disorders @RAPSorg https://t.co/cAewLypUY7
bioclinica (2 days ago)
RT @RAPSorg: Final @US_FDA Rule Requires Medical Device Trials Outside US to Conform to GCP | #Regulatory Focus https://t.co/jgwaqxfiXl #FD…
bioclinica (2 days ago)
Congrats @bioclinica on @Clin_Info_News Best Practices Award 4 "Transformational Med. Imaging in #ClinicalTrials. '… https://t.co/NxauNywq23
bioclinica (6 days ago)

Latest Blogs:

Latin America: Benefit from the Right Partner
Removing Risk from Clinical Trial Management System (CTMS) Implementations
Collaboration Between Clinical Operations and the Logistics and Supply Chain Teams is Key to Trial Success
The Value of Protocol Review
CTMS and RBM: Hot Topics at OCT Nordics in Copenhagen