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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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Congrats @bioclinica on @Clin_Info_News Best Practices Award 4 "Transformational Med. Imaging in #ClinicalTrials. '… https://t.co/NxauNywq23
bioclinica (Yesterday)
RT @BrianSMcGowan: Allison Proffitt Editor of Clinical Informatics News, Best Practice Awards @ from Clin_Info_News ... recognizing applied…
bioclinica (3 days ago)
@Clin_Info_News @IQVIA_global @CRFHealth All of us @Bioclinica are truly honored to receive this recognition. Congr… https://t.co/mULb8tatJ2
bioclinica (3 days ago)
RT @Clin_Info_News: Congrats again to @IQVIA_global @CRFHealth @bioclinica on winning the @Clin_Info_News Best Practices awards at #SCOPE20…
bioclinica (3 days ago)
And the winner is! Transformational Medical Imaging in #ClinicalTrials: @bioclinica SMART. @Clin_Info_News Best Pra… https://t.co/IYZoWoK8CB
bioclinica (3 days ago)
Folks at #SCOPE2018 hearing from Eric Forsthoffer and Rebecca Lupo about Bioclinica's Site Network.… https://t.co/aHRJtHb6zz
bioclinica (3 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