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Drug Safety Services

Bioclinica Safety Services provide drug safety and pharmacovigilance services to small, mid and large sized pharmaceutical and biotechnology companies. Our team consists of highly qualified and skilled experts who are committed to helping life sciences companies meet the challenging demand of producing detailed and accurate safety reports within the regulatory timelines.

Our broad range of solutions include full case management (including case intake, data entry, coding, triaging, QC, medical review, submission, etc.), generation of expedited and periodic reports, Qualified Person for Pharmacovigilance (QPPV) services, medical literature review, analysis and trending of cases (signal detection), and call center services that handle medical inquiries/information, AE/SAE case intake and product complaints.

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Leader in Clinical Trial
Management Solutions

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 advice from our Dir. Cardiovascular Imaging on how to achieve top quality imaging acquisitions & assessments… https://t.co/P57970FrOf
bioclinica (18 hours ago)
RT @CenterWatch: #CWWeekly: The increasing trend of adopting digital health and #mhealth apps for patient care. Read more, https://t.co/wo9…
bioclinica (19 hours ago)
RT @CenterWatch: Examining the difference between #patient engagement & patient recruitment. Read more in #CWPulse by @AshleyTointon, https…
bioclinica (19 hours ago)
RT @CenterWatch: How can #socialmedia play a role in health disparities and #clinicaltrial patient recruitment? Read more in #CWPulse by @A…
bioclinica (19 hours ago)
RT @RAPSorg: What New @FDAcdrhIndustry Guidance is Coming in FY 2018: Alternative 510(k) Pathway and More | #Regulatory Recon https://t.co/…
bioclinica (19 hours ago)
RT @RAPSorg: .@US_FDA Finalizes Guidance on Promotional Drug Labeling and Ads | #Regulatory Focus https://t.co/2rmtTWajlf #FDA #pharma
bioclinica (19 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