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eClinical

Risk Management and RTSM

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  • 17 Apr

The revisions in ICH E6 (R2) – Good Clinical Practice has garnered a lot of attention, not least because of the explicit recommendations for the incorporation of a formal risk analysis when planning and executing trials. The starting point for managing risk effectively is adopting a suitable risk analysis and mitigation method, such as risk scoring or failure modes effects analysis. We need to understand what could go wrong (hazard), what happens if it occurs (impact), how likely it is to happen (probability), and how likely we are to realize it has happened (detectability).

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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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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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Meet the Bioclinica eClinical Team: Amanda Nite, Senior Director of RTSM

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  • 17 Jan

Our flexible and innovative suite of eClinical solutions is supported by a team of people who have experience in all facets of clinical trials, which has been invaluable to our success. Therefore, we wanted to highlight a few valued contributors in this “Meet the Team” blog series.

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Meet the Bioclinica eClinical Team: Kristin Mauri, Global Head of Risk-Based Monitoring

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  • 18 Nov

Bioclinica's suite of eClinical solutions is designed to make your next clinical trial easier for you, your investigators and even your subjects. Our flexible and innovative eClinical solutions are supported by a team of people who have experience in all facets of clinical trials and help our clients seamlessly adopt new technologies and processes to improve their trials. Our team members are invaluable to our success, so we wanted to highlight a few of them in a "Meet the Team" blog series.

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4 Considerations for Choosing Key Risk Indicators (KRIs)

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  • 14 Sep

As a project manager and subject matter expert for Bioclinica's Compass RBM software, I've seen more and more companies turning to intelligent monitoring tools to track site performance and put their risk-based monitoring strategy into practice. When setting up a tool such as Compass, it's essential to choose the most important aspects of your trial to track in order to monitor site performance and identify areas on which to focus the most attention.

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6 Advantages of an Agile Approach to Interactive Response Technology (IRT)

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  • 13 Sep

In clinical trials, randomization and trial supply management (RTSM) solutions help randomize the participant allocation and ensure the study design is balanced and trial supplies are available when and where they are needed. A key piece of those efforts is the use of interactive response technology (IRT) software.

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Stronger Through Collaboration: A new wave of eHealth Solutions

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  • 15 Aug

Learning about new technologies and thinking strategically about their application in life sciences to ultimately benefit patients is what motivates me. This makes my role at Bioclinica a perfect fit as I get to partner with developers of innovative patient-centered applications from around the world for our eHealth App xChange.

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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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Bioclinica on Worldwide Business with Kathy Ireland

Worldwide Business with Kathy Ireland features Bioclinica!

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  • 06 May

Catch a candid discussion with Bioclinica experts as they discuss clinical trials and ways to simplify the clinical development process in a recent episode of Worldwide Business with Kathy Ireland®!

Each week the Fox Business Network sponsored program explores the real-world insights of corporate executives from around the globe.

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Pharmacovigilance in the EU: Master the requirements before marketing medicines

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  • 05 Apr

Planning to market medicines in the EU?

If you are, having a firm grasp of Good Pharmacovigilance Practices (GVP) requirements within the EU legislation is important. A knowledge gap in any area of the 16 GVP modules can surface as a compliance problem during an audit or inspection, carrying a hefty penalty and delaying regulatory approval. In extreme cases, a regulatory misstep or oversight can lead to forced withdrawal of a product from market.

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How RBM Technology Strengthens Sponsor-Site Ties

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  • 10 Jun

Why does it seem like problems surface at clinical research sites right about when the study team is either busy preparing for a monitoring visit or immediately following one?

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eClinical Lessons Learned

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  • 01 Jun

Part 2 of 2

In my last blog, I shared risk-based monitoring (RBM) lessons learned and RBM insights from the  BioClinica 5th Annual BioClinica Global User Conference held in May in Orlando, Florida.  Here is a recap of other eClinical sessions I had the pleasure of attending.

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Practical Risk Based Monitoring Methodologies

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  • 17 Mar

eClinical Greetings from Barcelona!
Jonathan Andrus
After a few crimps in the travel plans thanks to another winter storm hitting the US, everyone arrived safe and sound in sunny Barcelona for our second Annual European User Conference. It was two days of quality time with our customers and partners (recapped here in a news release).

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CTMS Microsoft SharePoint Integration Key to CROs

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  • 12 Mar

CTMS: Microsoft SharePoint Integration
When surrounded by such beauty and energy in Barcelona, who wants to sleep? Having just returned from BioClinica's European User Conference there last week, I admit I'm still reacclimatizing to the UK as I write this.

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Bioclinica is divided into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging and Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Biomarker Laboratory. Our eHealth segment comprises an eClinical Solutions Division along with Safety and Regulatory Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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