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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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Ck out best-of-breed trial #technologies & services: #RTSM, #esource, #EDC, site & patient #payments, global site… https://t.co/DJCNZ9C1uq
Bioclinica (Yesterday)
ICYMI: A discussion on recently released FDA draft guidance on assessment of blood pressure response in… https://t.co/7fmrkhhuQd
Bioclinica (Yesterday)
Our CIO & EVP Tech Gavin Nichols adds to #digitaltransformation discussion at #CMAsummit18 : W genomics & precision… https://t.co/oisqWvGJXC
Bioclinica (3 days ago)
Greetings from Tokyo where @bioclinica's Japan. China & US locations R@DrugInfoAssn DIA Japan. Discuss region-spec… https://t.co/HMzmFwA9pm
Bioclinica (5 days ago)
Reminder to join us in a live #Xtalks webinar tomorrow 11/6 on Electronic Data Capture (EDC). Everything clinical t… https://t.co/WS0L3QQnPv
Bioclinica (2 weeks ago)
Meet with representatives of Bioclinica's Japan, China & US locations at DIA Japan. Angel Y., Hidenori Seshimo & Er… https://t.co/j1alTH8oBm
Bioclinica (2 weeks ago)

Latest Blogs:

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Blood pressure monitor
Prescription box
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