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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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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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5 Reasons Why You Shouldn't Build Your Own Risk-Based Monitoring Tools

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  • 19 Jan

With risk-based monitoring (RBM) gaining traction in the clinical trial industry, you may be wondering how best to implement an RBM program at your company. Many companies prefer to use RBM software provided by an outside vendor, such as Bioclinica's ClearSite. However, other companies may decide to build their own RBM software or tools in-house.

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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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ROI Initiative: A Technology Solution for Investigator Payments

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  • 12 Jan

Managing investigator payments faces specific, well-known challenges. Current systems are fragmented and manual, and in most cases are not transactional or financial-based.

The result of continuing with current processes is the inability to manage the complexity of the contract and budget terms that are negotiated and paid throughout the course of a clinical trial. Current document management systems (e.g., CTMS and other homegrown systems) are based on non-financial system information that doesn’t manage or account for the accuracy of payments made.

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Is It Time to Embed Supply Chain Forecasting in Interactive Response Technology?

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  • 04 Jan

Some of my Bioclinica colleagues and I recently attended CBI's IRT 2016 conference in Philadelphia. While there were plenty of interesting topics discussed at the conference, one presentation particularly stuck out to me: the benefits of connecting supply chain forecasting for clinical trials more closely with interactive response technology (IRT) software. The reliance of effective clinical trial forecasting on IRT data is well understood within the clinical trial world, and was a big talking point at the conference.

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