Please Wait...

Classic Blog

Why Your RBM System Should be SMART, Not Pretty

  • 0
  • 09 Feb

There is long-standing recognition that Risk-Based Monitoring (RBM) is essential to ensuring the safety of your patients and the success of your clinical trial. Data quality and patient safety are also at the core of quality by design (QbD) initiatives, which focus on identifying key risks to subject safety, data quality and GCP/regulatory compliance, setting the foundation for RBM implementation.

Read More

How Optimizing Your Supply Chain Management Can Reduce Trial Cost, Effort and Risk

  • 0
  • 07 Feb

Today's Supply Chain
We can all recognize that there is a need to better manage the increasingly uncertain and complex drug supply chain, which is affected by the inclusion of more patients, at more sites and in more countries; country-specific regulations and approvals for temperature-controlled drugs, packaging, labeling and logistics; and more intricate protocols.

Read More

When Designing Clinical Trial Software, Put Your Users First

  • 0
  • 20 Jan

What's the best way to design software that your customers will actually enjoy using?

Ask your users.

It sounds obvious enough, but you would be surprised by how infrequently this perspective is taken into consideration when designing clinical trial software.

Read More

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

  • 0
  • 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.

Read More

Meet the Bioclinica eClinical Team: Amanda Nite, Senior Director of RTSM

  • 0
  • 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.

Read More

ROI Initiative: A Technology Solution for Investigator Payments

  • 0
  • 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.

Read More

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

  • 0
  • 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.

Read More

Meet the Bioclinica eClinical Team: Kristin Mauri, Global Head of Risk-Based Monitoring

  • 0
  • 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.

Read More

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

  • 0
  • 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.

Read More

Powerful Post-Approval Operational Strategies for the 21st Century

  • 0
  • 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.

Read More

3 Considerations When Implementing Risk-Based Monitoring Software

  • 0
  • 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.

Read More

Trends in Asia Drug Development Market

  • 0
  • 01 Nov

Innovation and Harmonization on the Rise

As R&D costs continue to hit new heights and domestic participation in clinical trials wane, more and more biopharmaceutical companies are seeking ways to mitigate costs and access new patient populations. Over the past decade, these driving market forces have contributed to a sharp rise in R&D activities, pharmaceutical market size, and the number of clinical trials conducted in Asia.

Read More

Pages

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

  • 0
  • 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

Read More

Four Reasons Your Site Activation Is Stuck in the Mud

  • 0
  • 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.

Read More

The Vaccine Trial Obstacle Course

  • 0
  • 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.

Read More

Bioclinica Medical Imaging 'Raising the Bar'

  • 0
  • 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.

Read More

Pages

LEARN MORE OR SPEAK WITH OUR EXPERTS

CONTACT US
Leader in Clinical Trial
Management Solutions

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.

RT @eClinical_Jen: FREE on-demand webinars from @bioclinica on EDC, Imaging, RBM, and Clinical Trial Management. Tell them I sent you! http…
bioclinica (14 hours ago)
Excited to host NJ Lt. Gov. Kim Guadagno, clients, partners 9/28 in Princeton! In the area? Join us ! RSVP… https://t.co/PrfyxvasGb
bioclinica (Yesterday)
Be sure to follow #ThankAScientist all week to thank researchers for the work they do! https://t.co/Sfi9mmHbSk… https://t.co/y9ZhBXsIzu
bioclinica (2 days ago)
Cardiovascular imaging use is growing in non-cardiovascular areas #ClinicalTrials. See where in Tim Crowe's blog… https://t.co/dYjPBC0Wtn
bioclinica (2 days ago)
RT @Xtalks: Cardiovascular Safety in #Biopharmaceutical Product Development - From QT Prolongation and Beyond @bioclinica https://t.co/mCk1…
bioclinica (2 days ago)
RT @Xtalks: How Innovations in Data Visualization Are Accelerating Data Cleaning and Improving Quality @bioclinica https://t.co/vfLU8pS9Rd
bioclinica (2 days ago)

Latest Blogs: