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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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Bioclinica’s Joby John reflects on the #SCDM2018 Annual Conference & being a part a thriving community of clinical… https://t.co/c70gH5kJo9
bioclinica (3 hours ago)
RT @bioclinica: Our own Jeff Heilbraun is in Tokyo nxt wk to lead a discussion at DIA’s Cardiac Safety Workshop in Japan. Jeff will give an…
bioclinica (8 hours ago)
RT @Xtalks: Trends in #SitePayments: Insight into How CROs Can Gain a Competitive Edge This webinar will focus on the latest market researc…
bioclinica (8 hours ago)
Great connecting w @bioclinica clients Odonate Therapeutics, Eisai, & PCI Biotech, at #ESMO18 #oncology… https://t.co/4wKrLof8e6
bioclinica (10 hours ago)
Our own Jeff Heilbraun is in Tokyo nxt wk to lead a discussion at DIA’s Cardiac Safety Workshop in Japan. Jeff will… https://t.co/BX6wzXctMm
bioclinica (3 days ago)
Let's talk oncology clinical trials at #ESMO18 ! Tap the knowledge of medical & scientific experts @bioclinica who'… https://t.co/RlTjGND5Qg
bioclinica (4 days ago)

Latest Blogs:

Dr. Joby John
Transformational Trends in Investigator Site Payments
Clinical Supply Chain Success: Leveraging Technology
Blood pressure monitor
Prescription box
Latin America: Benefit from the Right Partner