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

Trial Efficiency Improves With an Experienced Vendor IRT Team

  • 0
  • 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.

Read More

Study Points Way to Increased Efficacy in Respiratory Syncytial Virus Vaccine

  • 0
  • 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.

Read More

RBM SaaS Success: Avoid Validation Issues

  • 0
  • 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?

Read More

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

  • 0
  • 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.

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.

[LIVE WEBINAR 7/25] Pharmacovigilance case studies. https://t.co/wlO43PAptj https://t.co/wCtpPVsS6I
bioclinica (20 minutes ago)
Welcoming our new #eHealth App xChange Partner AB Cube! Get the news via @ClinicalLeader1 #pharmacovigilance https://t.co/EMe2pNjfTD
bioclinica (20 hours ago)
Let's keep the #AAIC2017 convos going! View #Alzheimer clinical trial resources https://t.co/PGVNjLuBCP
bioclinica (20 hours ago)
"Medical record mud run" 1 obstacle in vaccine trials w elderly. Here R 5 more & how to conquer by Dr. Craig Curti… https://t.co/5rO4jURlVF
bioclinica (21 hours ago)
News: AB Cube Joins @bioclinica App xChange. Cloud safety platform a catalyst for transformative safety change https://t.co/vXnRO8YgMa
bioclinica (Yesterday)
Our Medical Imaging team is in the spotlight for a job well done! https://t.co/6DZrRNZc7D
bioclinica (Yesterday)

Latest Blogs: