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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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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

  • 0
  • 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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Pages

CRO Oversight Is Not Optional: In-House Technology Solutions Can Help

  • 0
  • 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.

Read More

Fixing delays in study site activation: 3-Fold Solution

  • 0
  • 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.

Read More

Cardiovascular Imaging: Not Just for Cardiovascular Trials

  • 0
  • 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.

Read More

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

  • 0
  • 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.

Read More

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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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Cardiovascular imaging use is growing in non-cardiovascular areas #ClinicalTrials. See where in Tim Crowe's blog… https://t.co/7LvcKCds28
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