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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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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 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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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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Cardiovascular Imaging: Not Just for Cardiovascular Trials

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  • 03 Aug

Cardiovascular disease is the leading cause of death globally with approximately 17.3 million deaths annually. Underlying heart disease are numerous conditions such as atherosclerosis, myocardial infarction, ischemic stroke, heart failure, arrhythmias and heart valve issues.

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Patient Engagement in Alzheimer's and Mild Cognitive Impairment Clinical Trials

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  • 02 Aug

Considering the large number of individuals affected by Alzheimer's disease (AD) or Mild Cognitive Impairment (MCI), you might expect fast enrollment into clinical trials. The reality is quite different. Sponsors of clinical trials face several obstacles: 1) Patients are underdiagnosed. 2) Patients have a limited knowledge of clinical trials and some misconceptions. 3) AD/MCI clinical trials are complex, prohibiting participation.

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Upcoming Webinar: Outsourcing Pharmacovigilance: Pros and Cons and Lessons Learned

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  • 21 Jul

Join us for our upcoming webinar on July 25th during which Sukrit Singh and Dr. Ayesha Hussain, both pharmacovigilance experts who are also Associate Directors of CRM at Bioclinica, Inc., will present and discuss case studies illustrating how market authorization holders and CROs are becoming partners of choice in the ever-changing world of pharmacovigilance outsourcing.

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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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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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8 Essential Imaging Strategies to Revolutionize Your Clinical Study

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  • 16 Oct

Imaging is utilized in clinical trials across most therapeutic areas and is leveraged to monitor safety, assess efficacy, and provide primary, secondary or exploratory endpoints. The challenge imaging has faced ever since it's been incorporated into clinical trials is that it has succumbed to being "the forgotten one". Many times the preparation and conduct of imaging is an afterthought in clinical trials and for whatever reason is thought to be an easy part of the study design, implementation and execution. Nothing could be further from the truth.

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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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Gain Payment Transparency and Visibility With ClinViz

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  • 10 Oct

Site satisfaction is recognized as an important factor for adherence to trial timelines and budget costs. And, sites report getting paid on time as a top-ranked concern, with one-third of North American sites waiting at least 90 days for payments. Slow payments cause financial stress for most sites and can result in high site turnover, while on-time payments motivate sites to drive data quality results and optimize site performance.

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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.

Handy guide for the pharmacovigilance folks! https://t.co/tOyQWkiNhW
bioclinica (Yesterday)
#ClinicalResearch sites, REJOICE @bioclinica SMART Submit 4 cloud rsch image mgmt /subm is here! @OutsourcPharmahttp://ow.ly/odCh30grhnY
bioclinica (Yesterday)
What's next from Bioclinica? Hear if first during #PCTrials Europe next week in Amsterdam! https://t.co/ICngaxA9mg https://t.co/SXxPj3NpD2
bioclinica (2 days ago)
Join Bioclinica's Justin Hunt on Nov. 28 in a live webinar! Find out how to overcome common hurdles in CTMS impleme… https://t.co/wHfWHtI7sj
bioclinica (3 days ago)
Another CRO seeing big gains in the sites payments process! Access the Case Study here https://t.co/jsCxhmKcLo https://t.co/LpIKEtBKtE
bioclinica (3 days ago)
Great advice from our Dir. Cardiovascular Imaging on quality imaging acquisitions & assessments in clin trials. https://t.co/OVH7pZ3SL0
bioclinica (4 days ago)

Latest Blogs:

Removing Risk from Clinical Trial Management System (CTMS) Implementations
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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