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Removing Risk from Clinical Trial Management System (CTMS) Implementations

Upcoming Webinar: Removing Risk from Clinical Trial Management System (CTMS) Implementations

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  • 15 Nov

Join us for our upcoming webinar on November 28th during which Justin Hunt, Director of CTMS Implementation Services at Bioclinica, Inc., will present and discuss a case study providing insight into the benefits realized by a contract research organization (CRO) purchasing a CTMS who started with a small, limited implementation.

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CTMS and RBM: Hot Topics at OCT Nordics in Copenhagen

CTMS and RBM: Hot Topics at OCT Nordics in Copenhagen

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  • 24 Oct

The 5th Annual Outsourcing in Clinical Trials (OCT) Nordics conference provided another outstanding opportunity to explore a beautiful city, stay in the world’s greenest hotel and gain additional insight into aspects of clinical trials that are important for my daily work and even those that don’t touch my daily eClinical life. The mix of representatives from long-established pharma, CROs, biotech and third-party vendors enabled refreshing conversations about how we can work together to improve our communication and move in synergy toward our shared goals.

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What's the Role of a Data Manager in a Risk-Based Model?

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  • 17 Oct

Risk-based monitoring (RBM) is finally starting to gain momentum as the standard for trial execution within the industry. In fact, a few of the TransCelerate companies are already working in a model where RBM is deployed across all trials, and RBM is also finally starting to take off with mid-size to small pharma. Before long, RBM will become the de facto standard for trial execution. Because on-site monitoring practices were the first to change in the move toward an RBM-based strategy, the initial impact has been absorbed by clinical operations teams.

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Webinar Q&A Follow Up: How Innovations in Data Visualization Are Accelerating Data Cleaning and Improving Quality

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  • 12 Oct

On September 18, I presented a webinar entitled "How Innovations in Data Visualization Are Accelerating Data Cleaning and Improving Quality," during which I discussed the importance of database (DB) lock as a trial milestone. A key step towards DB lock is tracking all activities are completed and clean for each patient (coding, external data reconciliation, query status, etc.), which can often be a challenge particularly for studies with large amounts of data.

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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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CRO Oversight Is Not Optional: In-House Technology Solutions Can Help

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  • 08 Aug

Ensuring regulatory compliance is quickly becoming a primary reason to consider implementing an in-house, risk-based management/clinical trial quality management system. When sponsors outsource to a CRO, I've found that they often feel as if they are absolved of knowing exactly what is happening, ignoring the need for documented, risk-based oversight processes and procedures.

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Fixing delays in study site activation: 3-Fold Solution

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  • 04 Aug

What's behind slow site activation?

Sean Stanton of Bioclinica Research provides meaningful insights on study site activation in his latest article, 'Improving Site Activation: Three-Fold Solution' published in ICT's August 2017 issue.

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The Increasing Role of Technology in Supporting ICH E6 R2

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  • 16 Jun

As you may already be aware, a key recommendation in the latest revision to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH E6 R2), finalized in November 2016, is the use of a quality-based approach inclusive of risk-based monitoring (RBM). It also recommends centralized monitoring processes. These should complement and potentially allow you to reduce the extent and frequency of on-site monitoring, freeing up valuable resources and providing the opportunity to:

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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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Realize the Benefits of a Fully Developed CTMS Without the Typical Time to Implement, Using OnPoint Direct CTMS

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  • 25 Apr

In our experience, many small- to mid-sized companies view the implementation of a Clinical Trial Management System (CTMS) to be too resource-intensive (finances, time and human resources); because of this and other reasons, many of these companies compromise with systems comprised primarily of manual processes using spreadsheets, half-built internal systems or less-than-ideal implementations. However, CTMS plays an integral role in the conduct of your trials, and the implementation should support your specific needs.

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Top 5 Criteria for Your RBM Software Selection

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  • 20 Apr

There is increasing recognition of the importance of implementing risk-based monitoring (RBM) systems to aid with the monitoring and reporting of relevant risks in clinical trials, rather than relying on traditional methods based on disparate data sources and manual collation processes. Software-based RBM systems automate predetermined monitoring tasks, provide alerts for identified risks and can provide audit trails for regulatory submissions. However, all RBM systems are not the same.

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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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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