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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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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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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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Meet the Bioclinica Safety and Regulatory Team: Sukrit Singh, Engagement Manager

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  • 07 Nov

Bioclinica's Safety and Regulatory Solutions division provides optimal drug safety, regulatory affairs and clinical services to CROs and sponsors. Our services are supported by our knowledgeable team members, who have experience in a wide variety of roles within the safety and regulatory sphere of clinical trials.

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Powerful Post-Approval Operational Strategies for the 21st Century

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  • 03 Nov
Post-approval research studies are vastly different from pre-market studies designed for the registration of a new drug or device. In the white paper "One Size Doesn’t Fit All": Applying an Innovative Mindset to Post-Approval Research, I outline these differences and illustrate why companies ought to leverage strategies, processes, standard operating procedures (SOPs), and technologies that are specifically designed for and more relevant to post-approval research.
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3 Considerations When Implementing Risk-Based Monitoring Software

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  • 02 Nov

With regulatory agencies placing greater emphasis on risk-based monitoring (RBM) in clinical trials, the use of tools for RBM has become more and more crucial to success within the industry. If you're considering adopting an intelligent monitoring solution or if you're in the early stages of implementing such a tool, it's important to set yourself up for success early on by keeping a few things in mind. In my experience working with customers to implement Compass, I've learned a few key criteria that companies should consider to ensure RBM success.

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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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