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Speeding Up Site Activation Is as Easy as 1-2-3

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  • 11 Jul

Nobody wants a delay in site activation for a clinical trial. Every delay increases study budgets and reduces the time for market exclusivity. A delay means patients aren't getting needed drugs. Yet delays happen – consistently. So what is the secret to swift site activation? What is the "special sauce" to speed up the process and get studies started on time?

Actually, there is no secret. No mystery. No complicated formula. The fact is, speeding up site activation is as easy as 1-2-3.

1. Practice Leadership at Every Level

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Four Reasons Your Site Activation Is Stuck in the Mud

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  • 05 Jul

You have a new drug awaiting clinical trial, but your site activation process is stuck in the mud. Every day that passes is another delay in finding the patients you need. Getting the data you want. Generating the revenue you require. So why is site activation such a slow slog?

#1. Training Tribulations
To fulfill trial protocols, sites have to train and re-certify personnel and equipment for each and every study. Lab training, rater training, electronic data capture (EDC) training and more all take time – sometimes up to 30 hours per person.

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The Vaccine Trial Obstacle Course

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  • 27 Jun

Six Challenges to Recruiting Among the Senior Citizen Population

Recruiting patients for any clinical trial involves some bumps in the road. But recruiting among the senior citizen population for a vaccine-related clinical trial can be a veritable obstacle course. Here are six of the challenging elements you will have to overcome.

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Bioclinica Medical Imaging 'Raising the Bar'

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  • 23 Jun

As President of Bioclinica's Medical Imaging & Biomarkers business it is my pleasure to share with you that our team has been recognized by a top biopharma company with the 2017 'Raising the Bar' award for delivering medical imaging excellence in support of multiple global clinical development programs.

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Streamline the Financial Management of Your Trials With the ClinPay and ClinPlan Integration

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  • 22 Jun

Although our financial lifecycle solutions are powerful on their own, they provide even greater benefits when used together. This is especially true of ClinPay and ClinPlan; the recent integration of these two products streamlines the financial lifecycle of clinical trials from end to end.

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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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Recruiting Senior Citizens for Vaccine Trials Requires Circle of Trust

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  • 15 Jun

Senior citizens tend to have less-than-optimal vaccination rates – even for proven vaccines that bring significant health benefits. Unsurprisingly, then, they are hesitant to engage in vaccine-related clinical trials to test new medications. The way to remove this hesitancy is to engage senior citizens by building a circle of trust: a circle that has as its center the education of both the site staff and potential patients.

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Upcoming Webinar: How Improving Site Payments Can Make You the Sponsor/CRO of Choice

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  • 13 Jun

Join us for our upcoming webinar on June 27th where Lorie McClain, the VP of Product Management and Product Development and Technology at Bioclinica, Inc., and other Bioclinica clinical payments experts will present and discuss case studies illustrating how trial sponsors and CROs are becoming partners of choice at high-performing sites.

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Trial Efficiency Improves With an Experienced Vendor IRT Team

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  • 08 Jun

With the increasing complexity in protocols and need to increase the cost-effectiveness of studies, your IRT-related decisions play an even greater role in ensuring the most appropriate patient randomization and clinical supply strategies. Gone are the days of being able to use the "tried and true" IRT systems without further consideration of if they meet your protocol requirements.

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Study Points Way to Increased Efficacy in Respiratory Syncytial Virus Vaccine

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  • 06 Jun

Respiratory syncytial virus (RSV) is increasingly being recognized as an important cause of disease in older adults worldwide. Its impact is estimated to be comparable to or even greater than that of influenza. However, RSV is not typically tested for, as there is no specific treatment. A successful vaccine would represent a vital breakthrough, deeply benefiting this growing segment of the population.

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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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Meet the Global Head of Bioclinica's Pharmacovigilance and Regulatory Operations

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  • 27 Apr

Aman Wasan heads Bioclinica's Safety & Regulatory Services and also serves as Country Head for India Operations. Bioclinica offers specialized pharmacovigilance (PV) services including end-to-end case processing, aggregate reporting, signal detection/assessment and safety call center services to biopharmaceutical organizations across the globe. Bioclinica also specializes in PV as a Service (PVaaS) and as a traditional on-premise model.

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Congressman Patrick Meehan Visits Bioclinica

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  • 31 Aug

Congressman Meehan and Bioclinica CEO John Hubbard at recent visit to Bioclinica's Audubon offices

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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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Upcoming Webinar: IRT Best Practices: How Companies Are Accelerating Timelines While Improving Quality

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  • 23 Aug

Join us for our upcoming webinar on September 13th during which Bioclinica experts Amanda Nite, Senior Director of RTSM Operations and Commercial Solutions, and Robin Barber, Manager of RTSM Solutions Engineering, will present and discuss case studies providing insight into how to improve quality and reduce risk while accelerating timelines using agile methodologies.

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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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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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