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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

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 organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

Welcoming our new #eHealth App xChange Partner AB Cube! Get the news via @ClinicalLeader1 #pharmacovigilance https://t.co/EMe2pNjfTD
bioclinica (18 hours ago)
Let's keep the #AAIC2017 convos going! View #Alzheimer clinical trial resources https://t.co/PGVNjLuBCP
bioclinica (18 hours ago)
"Medical record mud run" 1 obstacle in vaccine trials w elderly. Here R 5 more & how to conquer by Dr. Craig Curti… https://t.co/5rO4jURlVF
bioclinica (19 hours ago)
News: AB Cube Joins @bioclinica App xChange. Cloud safety platform a catalyst for transformative safety change https://t.co/vXnRO8YgMa
bioclinica (23 hours ago)
Our Medical Imaging team is in the spotlight for a job well done! https://t.co/6DZrRNZc7D
bioclinica (Yesterday)
What's new in tech for ICH E6 R2 reqs for quality and #RBM? https://t.co/xsmNm8d35o #Pharma
bioclinica (Yesterday)

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