Camargo
JULY 1, 2020
This blog features considerations and recommendations for sponsors exploring a 505(b)(2) pathway to drug approval. The post A 505(b)(2) Primer: Building the Bridge Between an Approved Drug and Your Novel Therapy appeared first on Camargo.
JAMA Internal Medicine
JUNE 30, 2020
This observational study uses NCHS data to evaluate weekly changes in US deaths due to any cause and deaths due to pneumonia, influenza, or COVID-19, by state, from March 1 through May 30, 2020.
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Intouch Solutions
JULY 2, 2020
COVID-19 has been a wake-up call for pharma to evaluate their organization’s digital maturity and ability to serve customers personalized experiences. Is your organization ready? The post Digital Transformation and COVID-19: A Catalyst for Change appeared first on Intouch Solutions.
My Local Study
JULY 2, 2020
Alzheimer’s disease is the most common form of dementia. Dementia is a universal label that defines the symptoms of mental decline associated with Alzheimer’s and other brain conditions. Typically, there are three stages that Alzheimer’s disease slowly progresses through. These are early (mild), middle (moderate), and late (severe). Over 50 million people worldwide have Alzheimer’s.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Imperical Blog
JULY 1, 2020
The last decade has seen an explosion in clinical trials for therapies focused on rare diseases. PhRMA reports that there are more than 800 orphan drugs currently in development or regulatory review. While rare diseases are rare in a singular sense, when combined, they affect more than 10 percent of the U.S. population. According to the NIH , 95 percent of rare diseases have no approved medicines and more than 85 percent are serious or life-threatening.
JAMA Internal Medicine
JUNE 29, 2020
In its most severe form, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), leads to a life-threatening pneumonia and acute respiratory distress syndrome (ARDS). The mortality rate from COVID-19 ARDS can approach 40% to 50%. Although the mechanisms of COVID-19–induced lung injury are still being elucidated, the term cytokine storm has become synonymous with its pathophysiology, both in scientific publications and the media.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Forte Research Systems®
JUNE 30, 2020
Social media connects users worldwide, helping people stay connected. Its role in clinical research has many recruiting and retention benefits.
Eye on FDA
JUNE 27, 2020
Any pandemic is a medical crisis first, but it is also a social crisis and in the case of COVID-19, it has been a financial crisis. On top of that, emerging pathogens push new legal issues into the forefront. Currently with COVID-19 we are at a great crossroads where businesses and services are opening up while at the same time the virus is surging out of control in several states.
JAMA Internal Medicine
JUNE 30, 2020
This cohort study describes risk factors and clinical characteristics and outcomes in 201 patients with coronavirus disease 2019 (COVID-19) pneumonia who developed acute respiratory distress syndrome or died.
Clinical Trial Gurus
JULY 3, 2020
Patients rely on the Informed Consent Form (ICF) to learn about the study they are enrolling into. For this reason, regulatory agencies focus on the process of consent. Monitors should therefore be aware of the common errors that occur during the consenting process and help sites document each step accordingly.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
ECRG Media's Clinical Research Podcast
JUNE 29, 2020
What Constitutes Clinical Research Experience? Don't forget to Subscribe for new content! Subscribe: [link] Call or Text: 910-502-3732 Email: eliteclinicalgroup@gmail.com Podcast: [link] Steemit: [link] Advertise: eliteclinicalgroup@gmail.com Watch: » Industry News: [link] » All Videos: [link] » Interview Recaps: [link] » Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education Send
Pharma Marketing Network
JUNE 29, 2020
Earlier this year, Google Chrome announced that they would be phasing out 3rd-party cookies, a change that is expected to take place in 2022. Instead, the company will be using a less invasive solution called Privacy Sandbox, designed to protect user privacy while continuing to allow advertisers to accurately track and measure their digital campaigns.
JAMA Internal Medicine
JUNE 30, 2020
This Viewpoint explores challenges in the Italian health care system during the coronavirus disease 2019 pandemic and how other countries can plan for optimal actions.
Clinical Trial Gurus
JULY 1, 2020
Many people in the pharmaceutical industry underestimate and are underinformed about the importance of medical device trials. An expert in medical device testing explains the many similarities between Investigational New Drug (IND) and pharmaceutical trials. Entering the IND testing arena may offer many opportunities for growth for people who are highly driven and who are able to identify market needs.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
ECRG Media's Clinical Research Podcast
JUNE 29, 2020
What Constitutes Clinical Research Experience? Don't forget to Subscribe for new content! Subscribe: [link] Call or Text: 910-502-3732 Email: eliteclinicalgroup@gmail.com Podcast: [link] Steemit: [link] Advertise: eliteclinicalgroup@gmail.com Watch: » Industry News: [link] » All Videos: [link] » Interview Recaps: [link] » Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education.
Triage Cancer
JUNE 29, 2020
Accessing preventative services, including cancer screenings, is always important. However, during a pandemic you may be facing additional barriers but reporting symptoms to your doctor and accessing screening is part of early detection. Here are 4 answers to your most common questions from our partner, the Know Your Lemons Foundation. It can be an anxious time when you notice a change in your breast, or going for your first mammogram.
Intouch Solutions
JUNE 29, 2020
A team from Intouch Solutions, a full-service agency serving the pharmaceutical industry, won two challenges in a six-week-long virtual hackathon hosted by Hedera, a public distributed ledger and governing body created to support decentralized applications running at web scale. The post Intouch Team Brings Home Wins From the Hedera20 Hackathon appeared first on Intouch Solutions.
Clinical Trial Gurus
JUNE 29, 2020
An entrepreneur with a background in hospitality shares his experience as he poses as a study participant. He quickly discovered that the process for becoming a patient is slightly complicated. After reflecting on how complicated it is to become a study participant, he strongly urges sites to do whatever he can to retain patients by making simple changes such as being more approachable or providing a 24-hour number to patients.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Pharma Packaging Solutions
JUNE 29, 2020
Hiring Scam Alert. Someone posing as us (under the names Carton Service or Pharma Packaging Solutions) is contacting potential job seekers and making an offer of employment. Here are the ways you will recognize that this is a scam: The job opportunity is a remote work opportunity. Carton Service Inc./Pharma Packaging Solutions DOES NOT have remote work job opportunities.
Forte Research Systems®
JULY 2, 2020
Fireside Chats, a new virtual series presented by Advarra, launches this month, bringing the research community together to discuss challenges and potential solutions.
Pharmacy Checkers
JULY 2, 2020
According to a study published in the Journal of the American Medical Association (JAMA), 1.5% of adults in the U.S. who take prescription drugs purchase them from outside the U.S. to save money each year. That’s about 2.3 million people. In 2016, my review of a similar set of data estimated about four million per year. The Kaiser Family Foundation’s 2016 poll data was used to support an estimate showing that 19 million people, 8% of the adult population , have imported lower cost prescription d
pharmaphorum
JULY 1, 2020
This webinar will look at how pharma can use modular content in its multichannel and omnichannel strategies.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Pharma in Brief
JULY 1, 2020
On June 25, 2020, the Federal Court ( FC ) issued its latest Practice Direction and Order ( FC Update ) regarding Court operations during the pandemic, announcing that its Suspension Period will no longer be in force anywhere in Canada as of June 30, 2020. The FC Update also establishes guidelines for the transition toward more regular operations. Background.
DM Clinical Research
JUNE 29, 2020
COVID-19 is currently sweeping through the United States. While most of us are overwhelmed by this disease, scientists are developing plans to beat the virus. Worldwide clinical trials are an important part of that plan. Below, we will explain how these trials will help us better understand- and treat- this coronavirus. Trials Are How Scientists Learn.
Cloudbyz
JUNE 28, 2020
In this blog we will learn Salesforce flow and how it is similar to apex coding. Salesforce flow is a declarative way (Drag & Drop) of implementing an automation that is required for a business process alternative to code. Blog covers types of flows, elements, resources and good comparison with a sample apex code. Salesforce flow is a very powerful tool for admins/developers along with process builders and workflows.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
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