Please Wait...

Classic Blog

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

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

  • 0
  • 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.

Read More

The Increasing Role of Technology in Supporting ICH E6 R2

  • 0
  • 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:

Read More

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.

Read More

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

  • 0
  • 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.

Read More

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

Realize the Benefits of a Fully Developed CTMS Without the Typical Time to Implement, Using OnPoint Direct CTMS

  • 0
  • 25 Apr

In our experience, many small- to mid-sized companies view the implementation of a Clinical Trial Management System (CTMS) to be too resource-intensive (finances, time and human resources); because of this and other reasons, many of these companies compromise with systems comprised primarily of manual processes using spreadsheets, half-built internal systems or less-than-ideal implementations. However, CTMS plays an integral role in the conduct of your trials, and the implementation should support your specific needs.

Read More

Top 5 Criteria for Your RBM Software Selection

  • 0
  • 20 Apr

There is increasing recognition of the importance of implementing risk-based monitoring (RBM) systems to aid with the monitoring and reporting of relevant risks in clinical trials, rather than relying on traditional methods based on disparate data sources and manual collation processes. Software-based RBM systems automate predetermined monitoring tasks, provide alerts for identified risks and can provide audit trails for regulatory submissions. However, all RBM systems are not the same.

Read More

Risk Management and RTSM

  • 0
  • 17 Apr

The revisions in ICH E6 (R2) – Good Clinical Practice has garnered a lot of attention, not least because of the explicit recommendations for the incorporation of a formal risk analysis when planning and executing trials. The starting point for managing risk effectively is adopting a suitable risk analysis and mitigation method, such as risk scoring or failure modes effects analysis. We need to understand what could go wrong (hazard), what happens if it occurs (impact), how likely it is to happen (probability), and how likely we are to realize it has happened (detectability).

Read More

Pages

Upcoming Cardiac Safety Webinar Series

By Anonymous (not verified)
  • 0
  • 25 Sep

Join Bioclinica's Cardiovascular Safety experts this October for a 3-part webinar series as they review recent advancements and direction in the evaluation of cardiac safety and efficacy in drug development. Through use of case studies, presenters will share insights focused on the recent ICH E14 Q&A, application of cardiovascular imaging in drug safety monitoring and electronic clinical event adjudication.

Read More

To Thorough QT or Not to Thorough QT – That is the question

  • 0
  • 21 Sep

Thanks to scientific advancements and increased understanding of pathways and systems that contribute to cardiac risk, the cardiac safety ECG environment continues to mature and expand. Presently, the assessment of QT/QTc from the electrocardiogram is the primary focal endpoint in cardiac safety.

Read More

Upcoming Webinar: Clinical Payments Case Studies: Improving Efficiency, Cash Management, and Compliance

  • 0
  • 19 Sep

Join us for our upcoming webinar on September 26th during which Bioclinica expert, Lorie McClain, Vice President of Product Management, Product Development & Technology, will present and discuss case studies providing insight into how improvements in clinical payments can make your clinical trials more efficient, while improving your cash management and compliance.

Read More

Optimizing the Approach to IRT Customization

  • 0
  • 07 Sep

The clinical randomization and supply chain management systems we now dub “IRT” were initially built as fully customized IT projects, individualized and implemented separately for each study. While the processes have improved since then and some IRT providers are now using systems designed for more configurability, the mindset of customizing IRT systems for each study persists.

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.

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 (3 days ago)

Latest Blogs:

Removing Risk from Clinical Trial Management System (CTMS) Implementations
Collaboration Between Clinical Operations and the Logistics and Supply Chain Teams is Key to Trial Success
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