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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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Biomarkers and Personalized Medicine: Essential Tools

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  • 28 Mar

The use of biomarkers is expanding across all stages in the drug development process, helping bring about new and innovative practices in the treatment of many diseases, including Alzheimer's and cancer. With their ability to revolutionize development of advanced therapeutics, biomarkers have become essential tools.

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Successful Direct-to-Patient Shipping of Study Drugs

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  • 27 Mar

Clinical trials for patients with rare, debilitating diseases who have limited mobility and greater caregiving requirements can be challenging, particularly for clinic visits and medication adherence. But, we like a challenge. In a recent clinical trial, we collaborated with the sponsor to successfully ship the study drugs directly from the depot to a sample of US-based patients with a rare, progressive debilitating disease characterized by motor, cognitive and behavioral symptoms.

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Meet the Bioclinica Financial Lifecycle Solutions Team: Bob Gabriel, Senior Vice President and General Manager, Bioclinica FLS

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  • 17 Mar

Bob Gabriel is the Senior Vice President and General Manager of Bioclinica's Financial Lifecycle Solutions (FLS) division. The FLS suite of financial lifecycle products assists with managing the global automation and financial management of clinical trials and includes ClinPay, a proprietary transaction engine and secure online clinical trial payment network; ClinPlan, a budget management and cash forecasting solution; and ClinDebit, a patient reimbursement solution.

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Pathway to Quality Cardiovascular Imaging Trials

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  • 13 Mar

Cardiovascular diseases are the leading cause of death in the world and as such, the cause, prevention and treatment of all cardiovascular disease remains a very active field in the research community. Cardiovascular Imaging is a primary therapeutic service area for Bioclinica, offering comprehensive centralized medical imaging services and support for the majority of all cardiovascular imaging (CVI) modalities leveraged to provide critical endpoint assessments in clinical research.

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Does Your RBM System Support the Recently Revised Guidelines to Have a QMS in Place?

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  • 03 Mar

The latest International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6 addendum includes recommendations for ensuring quality management in clinical trials at the forefront. In particular, the new section 5.0 outlines recommendations for quality management, stating that "sponsors should focus on trial activities essential to ensuring human subject protection and the reliability of trial results" within the seven areas that are described below.

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7 Advantages of a Site Network vs. Individual Sites for Clinical Trials

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  • 24 Feb

How many investigative sites will you need for your next clinical trial? Will you choose independently-operated sites or a network of sites? Do you know their differences and advantages? We polled our Research Network customers and staff, and share what they said in this blog.

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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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Why Your RBM System Should be SMART, Not Pretty

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  • 09 Feb

There is long-standing recognition that Risk-Based Monitoring (RBM) is essential to ensuring the safety of your patients and the success of your clinical trial. Data quality and patient safety are also at the core of quality by design (QbD) initiatives, which focus on identifying key risks to subject safety, data quality and GCP/regulatory compliance, setting the foundation for RBM implementation.

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How Optimizing Your Supply Chain Management Can Reduce Trial Cost, Effort and Risk

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  • 07 Feb

Today's Supply Chain
We can all recognize that there is a need to better manage the increasingly uncertain and complex drug supply chain, which is affected by the inclusion of more patients, at more sites and in more countries; country-specific regulations and approvals for temperature-controlled drugs, packaging, labeling and logistics; and more intricate protocols.

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When Designing Clinical Trial Software, Put Your Users First

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  • 20 Jan

What's the best way to design software that your customers will actually enjoy using?

Ask your users.

It sounds obvious enough, but you would be surprised by how infrequently this perspective is taken into consideration when designing clinical trial software.

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Upcoming Webinar: How Innovations in Data Visualization Are Accelerating Data Cleaning and Improving Quality

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  • 05 Sep

Join us for our upcoming webinar on September 18th during which Karen McPoyle, Director of Data Strategy & Solutions at Bioclinica, Inc., will present and discuss the importance of ensuring completed and clean activities for each patient, to achieve a successful and timely database (DB) lock.

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

Congressman Patrick Meehan Visits Bioclinica

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  • 31 Aug

Bioclinica was honored to host Congressman Patrick Meehan representing the 7th Congressional District in Pennsylvania in a visit to our Audubon, Pennsylvania offices on August 28. Congressman Meehan met with Bioclinica senior leadership, including our CEO Dr. John Hubbard...

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Four Steps to Creating a Roadmap to ICH E6 R2 Compliance

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  • 29 Aug

Since the release of ICH E6 R2 in November 2016, we have been flooded with opportunities to attend and view webinars, seminars and blogs on the topic. While extremely educational, these industry-led learning sessions rarely provide sponsors or CROs with what you so desperately need… a practical guide to creating a roadmap to compliance. While Regulatory Affairs (RA) and Quality Assurance (QA) departments have likely read these new guidelines, holistic organizational education and awareness of their impact and how they affect the way in which we execute trials are still lacking.

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IRT Best Practices: How Companies Are Accelerating Timelines While Improving Quality

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  • 23 Aug

Join us for our upcoming webinar on September 13th during which Bioclinica experts Senior Director of RTSM Operations and Commercial Solutions, and Robin Barber, Manager of RTSM Solutions Engineering, will present and discuss case studies providing insight into how to improve quality and reduce risk while accelerating timelines using agile methodologies.

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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.

Handy guide for the pharmacovigilance folks! https://t.co/tOyQWkiNhW
bioclinica (Yesterday)
#ClinicalResearch sites, REJOICE @bioclinica SMART Submit 4 cloud rsch image mgmt /subm is here! @OutsourcPharmahttp://ow.ly/odCh30grhnY
bioclinica (Yesterday)
What's next from Bioclinica? Hear if first during #PCTrials Europe next week in Amsterdam! https://t.co/ICngaxA9mg https://t.co/SXxPj3NpD2
bioclinica (2 days ago)
Join Bioclinica's Justin Hunt on Nov. 28 in a live webinar! Find out how to overcome common hurdles in CTMS impleme… https://t.co/wHfWHtI7sj
bioclinica (3 days ago)
Another CRO seeing big gains in the sites payments process! Access the Case Study here https://t.co/jsCxhmKcLo https://t.co/LpIKEtBKtE
bioclinica (3 days ago)
Great advice from our Dir. Cardiovascular Imaging on quality imaging acquisitions & assessments in clin trials. https://t.co/OVH7pZ3SL0
bioclinica (3 days 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