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Be Fully in Control of Your Clinical Trial Payments Process

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  • 27 Jun

During my years in the clinical research industry working closely with CROs and Sponsors, I've seen many organizations realize the benefits of switching from manual payment processes like Excel spreadsheets, which are time- and resource-intensive as well as error-prone, to automated payment solutions.

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New Apps Emerge for RBM!

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  • 09 May

App xChange adds Virtual Onsite Monitoring (VOS)

In advising and providing consulting to many different companies in recent years making a switch to risk-based monitoring (RBM) it's become apparent to me that the opportunity to improve patient safety and enhance data quality is the top reason for adoption.  Later this year when the revised ICH E6 (R2) guidance goes into effect we will have even more incentive to adopt RBM!

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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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Seamless integration: Getting more from financial management technology

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  • 26 Apr

Sitting in the CFO seat for several years opened my eyes to the significant role spreadsheets have played in financial management in industries such as clinical trials – and their many shortcomings in managing finances. Once the go-to method, spreadsheets are rapidly falling by the wayside as organizations recognize that automated solutions are not time-consuming, cumbersome and error-prone like spreadsheets are.

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Seeking Clarity in the Audit Approach

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  • 18 Apr

Many questions still remain several years after the July 2012 ODAC (Oncologic Drug Advisory Committee) Meeting on the "Evaluation of Radiologic Review of Progression-free Survival in Non-Hematologic Malignancies." Further investigation was recommended into the utility of taking an audit approach (central reads of a test sample) to identify potential bias in the local evaluation (LE) of patient data.

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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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RBM is Advancing: 3 Keys in Planning

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  • 09 Mar

While Miami warmth and sunshine in February was undoubtedly a main draw for some SCOPE Summit attendees, for the risk-based monitoring set it was something more. It was about the opportunity for our diverse group of stakeholders to come together and give feedback in an area increasingly growing in importance - quality and risk management.

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Governance and Collaboration: CTMS Checklist

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  • 02 Mar

A recent market research report forecasts that the eClinical solutions market will be worth 5.98 billion (USD) by 2020. With sponsors and CROs adopting new eClinical software, or replacing legacy systems, such as clinical trial management systems (CTMS), vendors are emerging with new software to stake a claim in this growing market.

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The Scoop from SCOPE Summit 2016

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  • 25 Feb

SCOPE Summit 2016 was a busy and exciting event for the Bioclinica team! In addition to the great discussions at the Bioclinica booth, Ron Burns, VP, Product Management, Bioclinica eHealth Solutions, held a session entitled, "Integrating Mobile Application Generated Patient Data into Your Risk-Based Monitoring Strategy." This session included Bioclinica eHealth App xChange Partner, AiCure.

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Get a First-Hand Glimpse into the Power of Mobile Application Generated Patient Data at SCOPE Summit 2016

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  • 18 Feb

The rapid growth of technology is revolutionizing the way clinical trials are conducted. Increasing adoption of smartphone use -- forecasted to reach over 6 billion by 2021 – combined with the growing biosensors market opens up new possibilities for a variety of healthcare-related uses. Innovative patient-centered mobile applications and biosensors now connect patients with physicians and other healthcare providers.

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Prompt Site Payments Key to Site Engagement

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  • 05 Feb

When it comes to achieving success in clinical trials, it truly takes a team. Sponsors, investigative sites and patients must work in partnership to complete this important work. However, with weighty matters in the clinical development process - shrinking pipelines, shortened patent life, patient population considerations, global safety standards, and the list goes on - the needs of investigative sites can be overshadowed.

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CDISC

CDISC Public Courses in Audubon, March 2-12: Register with CDISC today!

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  • 04 Feb

Here's a great opportunity to learn CDISC from CDISC at Public Courses being held in Audubon, Pennsylvania at Bioclinica's eHealth Headquarters on March 2-12. (Other dates and locations are available).

Why take CDISC Training?

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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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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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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.

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