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Safety & Regulatory Solutions

Upcoming Webinar: Outsourcing Pharmacovigilance: Pros and Cons and Lessons Learned

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  • 21 Jul

Join us for our upcoming webinar on July 25th during which Sukrit Singh and Dr. Ayesha Hussain, both pharmacovigilance experts who are also Associate Directors of CRM at Bioclinica, Inc., will present and discuss case studies illustrating how market authorization holders and CROs are becoming partners of choice in the ever-changing world of pharmacovigilance outsourcing.

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Meet the Global Head of Bioclinica's Pharmacovigilance and Regulatory Operations

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  • 27 Apr

Aman Wasan heads Bioclinica's Safety & Regulatory Services and also serves as Country Head for India Operations. Bioclinica offers specialized pharmacovigilance (PV) services including end-to-end case processing, aggregate reporting, signal detection/assessment and safety call center services to biopharmaceutical organizations across the globe. Bioclinica also specializes in PV as a Service (PVaaS) and as a traditional on-premise model.

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LitTRACE: Simplified Tracking and Assessment of Safety-Related Literature

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  • 12 Apr

The scientific literature has always been a very dependable source of information for identifying drug safety-related information, such as Individual Case Safety Reports (ICSRs), signals, aggregate report relevant information and epidemiology data. Tracking this safety information is mandated by regulatory agencies. Relevant safety information published in national and international journals, including that from local journals, conferences and symposia, are considered for assessment.

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Required eCTD Submissions as of May 5, 2017 – Are You Ready?

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  • 10 Apr

The electronic common technical document (eCTD) is an interface for the pharmaceutical industry to transfer regulatory information based on the Common Technical Document (CTD) format, which is an agreed common format for applications that will be acceptable in all three ICH-Regions (US, EU & Japan) and other countries.

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Reflections on My Experience at the 2017 DIA Pharmacovigilance and Risk Management Strategies Conference

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  • 22 Feb

Compared with the 2016 Drug Industry Association (DIA) Pharmacovigilance and Risk Management Strategies Conference, the 2017 conference in Washington, D.C. had a much better start. Although I was not at last year's conference, I read the epic testimonials of snowstorms, canceled flights, lockdowns and other interesting events, which were all very entertaining.

This year's DIA Pharmacovigilance and Risk Management Strategies Conference, which I attended, was less eventful, and yet, still full of encounters, lively discussions and as always, laughter.

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Meet the Bioclinica Safety and Regulatory Team: Sukrit Singh, Engagement Manager

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  • 07 Nov

Bioclinica's Safety and Regulatory Solutions division provides optimal drug safety, regulatory affairs and clinical services to CROs and sponsors. Our services are supported by our knowledgeable team members, who have experience in a wide variety of roles within the safety and regulatory sphere of clinical trials.

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Finding the Right End-to-End Safety Solution for Your Needs

Finding the Right End-to-End Safety Solution for Your Needs

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  • 25 Jul

Last week, I hosted a webinar titled, "Finding the Right End-to-End Safety Solution for Your Needs." During the webinar, we took an in-depth look at:

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Management Solutions

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.

RT @Xtalks: Removing Risk from #ClinicalTrial Management System (CTMS) Implementations @bioclinica https://t.co/EfuSVMSL13
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Our Research Dev. Director Marieke Cajal in a poster presentation at #CNS Summit showed, "How to Scale up Recruitme… https://t.co/ySQpGIjvt9
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Great advice on imaging in #clinicaltrials! https://t.co/adsP8h99Ic
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RT @Xtalks: When is Central Imaging Needed in #ClinicalTrials? @bioclinica https://t.co/fYGvqU46TI
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RT @phillytechnews: 11/7: BioClinica, USA Technologies buy California firms ; First Round names female general partner https://t.co/MAvm6…
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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