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Steve Goldstein

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Steve Goldstein
Director Study QC, IRT

Mr. Goldstein has over 20 years of regulated systems experience, which includes 13 focused on clinical IRT primarily for a clinical packaging and distribution vendor.  Mr. Goldstein brings a clinical supplies perspective to IRT systems that complements the clinical perspective employed on most IRT teams.  Mr. Goldstein joined BioClinica in 2009, and his current responsibilities include managing the Study QC team. He holds responsibility for study-specific testing, validation, and QC activities of BioClinica's EDC and IRT systems.  Mr. Goldstein received a B.A. in Chemistry from Cornell University and a M.S. in Chemical Engineering from Georgia Tech.

Blogs

With the increasing complexity in protocols and need to increase the cost-effectiveness of studies, your IRT-related decisions play an even greater role in ensuring the most appropriate patient randomization and clinical supply strategies. Gone are the days of being able to use the "tried and true" IRT systems without further consideration of if they meet your protocol requirements.

In the last blog we talked about how technology transfer is gaining ground on the conventional Software as a Service (SaaS) IRT sourcing model. In this blog post, I will explain the advantages of the technology and design behind Trident that make it particularly well-suited for IRT technology transfer. So let's dive right in.

When it comes to Interactive Response Technology (IRT) – systems used to perform subject randomization, drug dispensing and study drug resupply – Software as a Service (SaaS) continues to be the conventional delivery model including here at BioClinica.

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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.

Great advice from our Dir. Cardiovascular Imaging on quality imaging acquisitions & assessments in clin trials. https://t.co/OVH7pZ3SL0
bioclinica (42 minutes ago)
Almost here! #PCTrials Pre-arrange a meeting w @bioclinica Drop by & s/w David Kiger & Mike Lange. Mike will give a… https://t.co/8ymd2Q9KcJ
bioclinica (52 minutes ago)
Almost here! #PCTrials Pre-arrange a meeting w @bioclinica Drop by & s/w David Kiger & Mike Lange. Mike will giv… https://t.co/MpxTDV1T1L
bioclinica (54 minutes ago)
RT @bioclinica: Keeping to timelines in #clinicaltrials is key but can be hard to achieve. Join Bioclinica's Justin Hunt a webinar Nov. 2…
bioclinica (57 minutes ago)
RT @Xtalks: Removing Risk from #ClinicalTrial Management System (CTMS) Implementations @bioclinica https://t.co/EfuSVMSL13
bioclinica (7 hours ago)
Our Research Dev. Director Marieke Cajal in a poster presentation at #CNS Summit showed, "How to Scale up Recruitme… https://t.co/ySQpGIjvt9
bioclinica (7 hours ago)

Latest Blogs:

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
Congressman Meehan and Bioclinica CEO John Hubbard at recent visit to Bioclinica's Audubon offices