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RTSM

Collaboration Between Clinical Operations and the Logistics and Supply Chain Teams is Key to Trial Success

Collaboration Between Clinical Operations and the Logistics and Supply Chain Teams is Key to Trial Success

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  • 13 Nov

The need to collaborate with internal and external teams for a trial to be successful isn’t a new idea or concept. However, we still see the detrimental effects of a lack of communication between organizational teams; this is particularly true when the clinical operations team fails to communicate with the supply chain and logistics team about upcoming changes. Understanding how decisions made by one group ultimately impacts other groups is important for conducting a successful clinical trial.  

Let’s use a global trial with sites in Brazil as an example.

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The Value of Protocol Review

The Value of Protocol Review

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  • 08 Nov

One of our strategic customers recently invited me to review a draft protocol synopsis for a pivotal Phase III registration study. As the provider of the randomization and trial supply management (RTSM) solution  for the study, I relished the opportunity. Having reviewed thousands of protocols throughout my career, I knew that this was an ideal opportunity to consult with the clinical team to refine and optimize critical aspects of the study design.

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Optimizing the Approach to IRT Customization

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  • 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.

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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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Trial Efficiency Improves With an Experienced Vendor IRT Team

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  • 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.

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Risk Management and RTSM

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  • 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).

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Successful Direct-to-Patient Shipping of Study Drugs

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  • 27 Mar

Clinical trials for patients with rare, debilitating diseases who have limited mobility and greater caregiving requirements can be challenging, particularly for clinic visits and medication adherence. But, we like a challenge. In a recent clinical trial, we collaborated with the sponsor to successfully ship the study drugs directly from the depot to a sample of US-based patients with a rare, progressive debilitating disease characterized by motor, cognitive and behavioral symptoms.

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

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  • 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.

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

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  • 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.

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6 Advantages of an Agile Approach to Interactive Response Technology (IRT)

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  • 13 Sep

In clinical trials, randomization and trial supply management (RTSM) solutions help randomize the participant allocation and ensure the study design is balanced and trial supplies are available when and where they are needed. A key piece of those efforts is the use of interactive response technology (IRT) software.

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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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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