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Bioclinica's Research Network Goes Global with Compass Acquisition

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  • 12 Aug

Bioclinica's extensive Research Network of full-service clinical study sites – already located in Asia, Europe, and Latin America – achieved a global status with the recent acquisition of Compass Research. As reviewed in the CenterWatch Weekly publication, the acquisition will expand Bioclinica's Research Network into the U.S., providing a true global site network for pharmaceutical companies engaged in clinical research.

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How Do You Get People to Join Clinical Trials? Show a Movie!

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  • 10 Aug

Many people don't understand what a clinical trial is or how one is conducted. This can make it hard to recruit and screen the hundreds and often thousands of patients necessary to find qualified individuals to participate in a given study.

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End-to-End Patient Engagement Is a Reality

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  • 09 Aug

Patient engagement is an ongoing challenge when conducting clinical trials. A recent article published in CenterWatch Weekly noted, "Experts point to problems with awareness, understanding, and trust among potential trial participants as well as providers that persists today. They also cite the disconnect between a patient's interest in participating in a trial and actually taking the next step to enroll.

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Clinical Trial Forecasting: Managing the Challenges and Avoiding the Fines

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  • 08 Aug

Last week, Jim Sacchetta, Manager, Technical Operations, Premier Research, and I hosted a webinar titled "Clinical Trial Forecasting: Managing the Challenges and Avoiding the Fines." During the webinar, we took an in-depth look at:

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Explosive Growth in Post-Approval Research Drives Increased Cost and Complexity

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  • 04 Aug

In the 1970s, post-approval studies were rarely performed. The 1980s saw a slight rise when the FDA began to require post-approval research as a condition for the approval of certain drugs. Fast forward to 2014, when a full 13.7% of total R&D costs was spent on conducting post-approval studies. What fueled this explosive growth in post-approval research in such a relatively short period of time? And – critically – what are the ramifications of that growth?

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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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The Art of the Rescue - Navigating Potential Pitfalls during Imaging Vendor Transition

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  • 21 Jul

Once considered a rarity within the medical imaging vendor space, the decision by sponsors to transition imaging core lab after startup has become increasingly more common. Due to the complexity of clinical trials, there may come a time where as a Sponsor you will need to transition vendors after study startup. Reasons for this change of service provider can typically involve challenges with the current provider's timelines, quality, resources, or expertise.

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Introducing OnPoint Direct, Bioclinica's Powerful Rapid Startup CTMS

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  • 19 Jul

With thousands of people, hundreds of investigative sites, multiple CROs and various eClinical source systems—all generating massive amounts of data—clinical trials are an enormous undertaking. While leading organizations use Clinical Trial Management Systems (CTMS) to centralize operational data and automate processes so they can make better decisions, a CTMS can be out of reach for many small to mid-size companies, leaving them with isolated spreadsheets and/or inefficient, manual practices.

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Meet the Bioclinica Financial Lifecycle Solutions Team: Meghan Harrington, Director of Client Delivery

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  • 14 Jul

At Bioclinica, we are proud to provide our clients with scalable financial lifecycle solutions that can handle global payments as well as integrate with any EDC, CTMS and RTSM. As of April 4, 2016, we've helped Sponsors and CROs make $285 million in payments to 9,012 sites with 70,972 subjects in 63 counties. However, although our technology is a huge factor in our clients' successes, we wouldn't be nearly as successful without the extensive clinical trial expertise that our team members bring to the table.

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What’s Next for the European Economic Area (EEA) Qualified Person for Pharmacovigilance (QPPV) Working in the UK?

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  • 12 Jul

Last week, on June 23, 2016, the European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) acknowledged the outcome of the referendum on the United Kingdom's (UK) membership of the European Union (EU).

EMA stated that its implications for the Agency's location and operations depend on the future relationship between the UK and the EU, which is unknown at present.

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CDISC eSource Stakeholders Plan to Supply Pharma with Path Forward for Collection of EHR and Other eSource Data

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  • 11 Jul

CDISC held an eSource stakeholders meeting on March 18, 2016 during the CDISC interchange in Silver Spring, MD. The initial invitation said "During this initial meeting, we plan to discuss the charter and plans for this group as well as introduce members to each other and update the group on recent work."

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TransCelerate Companies Lead the Way in Adopting Risk-Based Monitoring

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  • 06 Jul

I recently had the opportunity to attend DIA. While listening to the panelists, I realized TransCelerate companies appear to be the furthest along in their journey of risk-based monitoring (RBM), and even so, RBM is still relatively new for most of them.

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Trial Efficiency Improves With an Experienced Vendor IRT Team

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  • 08 Jun

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.

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Study Points Way to Increased Efficacy in Respiratory Syncytial Virus Vaccine

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  • 06 Jun

Respiratory syncytial virus (RSV) is increasingly being recognized as an important cause of disease in older adults worldwide. Its impact is estimated to be comparable to or even greater than that of influenza. However, RSV is not typically tested for, as there is no specific treatment. A successful vaccine would represent a vital breakthrough, deeply benefiting this growing segment of the population.

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RBM SaaS Success: Avoid Validation Issues

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  • 30 May

As the industry and organizations' experience with risk-based monitoring and quality management in clinical trials matures, we're seeing a shift in the type of RBM systems being used. While custom-built systems were once many sponsors' go-to solution, we're increasingly seeing the use of off-the-shelf, cloud-based software, otherwise known as Software as a Service, or SaaS. (Disclaimer: Good news to us. Bioclinica offers a SaaS-based RBM solution, ClearSite.)

So why is RBM SaaS picking-up speed?

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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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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 @eClinical_Jen: FREE on-demand webinars from @bioclinica on EDC, Imaging, RBM, and Clinical Trial Management. Tell them I sent you! http…
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Be sure to follow #ThankAScientist all week to thank researchers for the work they do! https://t.co/Sfi9mmHbSk… https://t.co/y9ZhBXsIzu
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