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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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Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

Great #SCOPE2019 panel discussion today with industry veterans sharing ways sponsors and vendors can work together… https://t.co/U8j40R6y6R
Bioclinica (3 hours ago)
RT @teaminspire: Patients Are Eager for Trials But Aren’t Getting the Word, Survey Finds https://t.co/BfLxhmpzZg via @CenterWatch #clinical…
Bioclinica (9 hours ago)
RT @DrugInfoAssn: Didn’t make it to #DIAEurope2019 in Vienna? Read highlights from @EFPIA here: https://t.co/I1XYJkTBha
Bioclinica (9 hours ago)
RT @CDISC: Introducing the CDISC Library https://t.co/KsGqdqIZBO. Join the CDISC Data Science team for two informational webinars to accomm…
Bioclinica (9 hours ago)
RT @PhillyCooke: Reminder that @RAPSorg Philly chapter networking mixer is March 7 at @DePuySynthes in West Chester. Register now: https://…
Bioclinica (10 hours ago)
RT @FDAWomen: #BlackHistoryMonth is also #HeartMonth. With 48% of African American women having a form of cardiovascular disease, it is tim…
Bioclinica (10 hours ago)

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