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Todd Kisner

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Todd Kisner
Vice President, Quality Assurance & Regulatory Compliance

Mr. Kisner is the Vice President, Quality Assurance & Regulatory Compliance.  He oversees the Corporate Quality Management System and Regulatory Compliance groups.  He holds responsibility for ensuring BioClinica and its products and services comply with all regulatory standards as well as with industry best-practices.  With more than 20 years of experience in the pharmaceutical and technical industries, Todd has held numerous positions of increasing responsibility and joined BioClinica as the Vice President of Quality and Regulatory Affairs.  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.

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 the ACRO Global Data Protection and Privacy Committee (GDPPC) and Ethics & Regulatory Compliance Committee.

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

Webinars

December 31, 2019 - 12:00pm (EST)
Join this webinar to understand why and what regulatory elements should be considered even before you design your protocol and how this early adoption can lead to shorter, more successful clinical trials and smoother agency submission. Provided case studies will highlight benefits of having expert regulatory guidance, use of compliant processes mirroring FDA guidance and imaging standardization. Imaging charters, more complex Phase 3 and retrospective study considerations will be discussed.

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Bioclinica is divided into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging and Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Biomarker Laboratory. Our eHealth segment comprises an eClinical Solutions Division along with Safety and Regulatory Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

Our #Alzheimers expert's work will B showcased at #ADPD2017 Preview here https://t.co/nnbO9q8lVk @adpdnet
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#FunFriday ! A long time ago in a lab far far away.... https://t.co/2MrgKJhS07
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Smiles all around on Pizza Day today for @bioclinica eHealth in Audubon compliments of our CTO Andrew Masters. This… https://t.co/PbFoWnxn3B
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Missed Tuesday's webinar on agile #IRT? No worries! Catch it here > https://t.co/kKUIQEB0vI #Pharma #CRO #eClinical
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RT @ACROhealth: Where do you stand on regulating #mHealth & #Wearables in #clinicalresearch? w/ @bioclinica, @ICONplc, @INC_Research https:…
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RT @ACROhealth: ICYMI: @CCTAwareness’ Infographic on #clinicaltrials awareness for #Alzheimer’s and Parkinson’s treatments. https://t.co/84…
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