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RTSM

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

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  • 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.

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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 divided into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging and Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Biomarker Laboratory. Our eHealth segment comprises an eClinical Solutions Division along with Safety and Regulatory Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

[Fun Friday] Now that's using you noodle! Ck this out in @RandDMagazine https://t.co/o5h9O1ScBF
bioclinica (7 hours ago)
FDA, NIH & Industry Advance Templates for Clinical Trial Protocols | RAPS https://t.co/Cqda7fLQZf
bioclinica (Yesterday)
Significant Safety Events Found in a Third of FDA-Approved Drugs, Study Finds | RAPS https://t.co/mAHe42W4or
bioclinica (Yesterday)
FDA Official Highlights Foreign Supply Chain Challenges | RAPS https://t.co/qHDtoRw9MS
bioclinica (Yesterday)
RT @MySCRS: Survey finds 50% of Americans are unaware of #ClinicalTrials, reported by @EdClinical. https://t.co/57x8gtXRT0
bioclinica (Yesterday)
RT @ACROhealth: Recent poll data from @ResearchAmerica, 59% of those polled said their family’s health has been improved by clinical resear…
bioclinica (Yesterday)

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