May, 2020

What to Expect from the FDA During COVID-19 Product Development

Camargo

As the COVID-19 national emergency stretches on in the United States, the eyes of the. The post What to Expect from the FDA During COVID-19 Product Development appeared first on Camargo. Blog Regulatory Strategy & Submissions

It’s OK to Not Be OK

Find Me Cure

A chronic illness diagnosis can turn your world upside down. Especially an illness that can significantly limit your ability to do the things you love and be present with the people who matter to you. People with Myasthenia gravis have shared a lot of stories of missed friend birthdays, graduations, weddings… Here on the FindMeCure blog, we have always encouraged you to reach out and admit you’re struggling.

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The Mental Health Consequences of COVID-19 and Physical Distancing

JAMA Internal Medicine

This Viewpoint emphasizes the importance of mitigating the mental health consequences of social distancing in the COVID-19 era

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Even Drugs Manufactured in America are not “Made in the USA”

Pharmacy Checkers

PharmacyChecker pays close attention and has performed considerable research related to where drugs are made. Most notably, by researching drug labels and contacting drug companies, we found that 71% of brand name drugs sold in the U.S. are foreign made , a number far higher than the 40% figure regurgitated by the FDA year after year. Americans care a lot about this issue. One of our more popular Ask PharmacyChecker posts is called “ How can I determine where a drug is manufactured? ”

The Clinical Study Protocol: The Basics

Cloudbyz

If you are new to the clinical research industry, it’s important to know how clinical studies are developed and run. The basis for all such studies is the study protocol, about which this piece will provide a high-level overview. A study protocol is a document that provides an overview of the study. It includes information such as design, objectives, and methodology, and guides research conduct during the study. There are general templates that may be used to construct a protocol.

Adapting Clinical Trial Protocol in Response to COVID-19

VirTrial

Based on recent SCRS survey data , a vast majority of research sites (58%) anticipate that COVID-19 will negatively affect their clinical trial enrollment and nearly half of respondents (47%) feel COVID-19 will have a negative effect on retention. With the number of new cases increasing daily, these expectations are, unfortunately, likely to be correct. . Sponsors and sites will need to be resourceful over the coming months to keep ongoing trials running and avoid delays in new study starts.

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Living with a Chronic Illness During a Health Pandemic

Find Me Cure

Morgan from Is Was Will Be is one of those people who persevere despite the difficulties and no chronic illness can stop them from living their life to the fullest. On her blog, you’ll find all about the spoonie life, mental health and natural living so you can know you’re not alone on your journey. Today Morgan shares with FindMeCure what life is like with a chronic illness during a pandemic and how to preserve your sanity in these trying times.

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Clinical Trial Day: Celebrating 273 Years of Medical Advancements

My Local Study

When you hear ‘clinical trials,’ today you think about research sites, hospitals, and doctor’s offices. What you absolutely don’t think about is a British Royal Navy fleet ship ridden with scurvy, but that’s how clinical trials started! On this day, 273 years ago, surgeon mate James Lind conducted a clinical trial to advance medicine for. Read more Clinical Trial Day: Celebrating 273 Years of Medical Advancements.

Gilead says remdesivir is not sold online and they are correct

Pharmacy Checkers

A good portion of this blog takes on Big Pharma for their funding of misleading public information campaigns and programs against drug importation and the practice of safe international online pharmacies. Much of their messaging tries to convey that you can’t find their medications online at lower cost from other countries safely. Because of the work we do, we know for a fact that claim is ridiculous and independent research backs that up entirely.

The Plinth of Software Integration-In a Nutshell

Cloudbyz

The world perhaps is moving at a faster pace with substantial advancements in the technological sphere. Historians and scientists predict that the 21st century will be dominated by the trust-worthy alliance between AI and Biotech tactics. Everything the sapiens deal in their day-to-day life is interconnected and the viability of an earthling will be in a mess if there is any discrepancy between the interconnected systems.

VirTrial Announces Service for Virtual Site Monitoring Visits to Allow CRA’s Continued Access to Research Sites During COVID-19 Pandemic 

VirTrial

Scottsdale, AZ (May 26, 2020) – VirTrial today announced a new service designed to enable virtual site monitoring visits in the clinical trials industry. The solution enables pharmaceutical sponsors and CROs to evaluate, qualify and routinely monitor research sites for studies without physical travel. The service is the industry’s first patent-pending virtual site monitoring solution.

Choosing the Right Animal Model for COVID-19 Nonclinical Research

Camargo

Research into drugs and vaccines to combat the ongoing COVID-19 pandemic caused by the SARS-CoV-2. The post Choosing the Right Animal Model for COVID-19 Nonclinical Research appeared first on Camargo. Blog Nonclinical Testing

Seasonal Allergies Vs. Sinus Infection Symptoms

DM Clinical Research

Is your stuffy, runny nose taking over your life? Sinus and nasal issues are very common during the spring and summer months. While some people have symptoms that last for a few days, other people have chronic issues. The two most common culprits are seasonal allergies and sinusitis. But how do you know which issue you have? Below, we will go over seasonal allergies vs. sinus infection symptoms. Common Allergy Symptoms. People with allergies can deal with a variety of symptoms.

PwC Pharma & Life Sciences Webinar: COVID-19 impact on the ITX and regulatory DNA

Pharma Business Blog

Dear pharma & life sciences colleagues, It was a pleasure to welcome you to our webinar: PwC Pharma & Life Sciences Webinar: COVID-19 impact on the ITX and regulatory DNA. Attached below you can download the presentation. Should you have any questions, please get in touch with us, we are happy to discuss them with you. We look forward to meeting you again soon.

Potential Importance of Personal Importation Will Rise as Tens of Millions Lose Health Insurance

Pharmacy Checkers

Americans without health insurance are four times more likely to buy a prescription drug from another country due to cost. That’s from an analysis by the U.S. Centers for Disease Control and Prevention, National Center for Health Statistics , published in 2015. Not surprisingly, more comprehensive health insurance generally leads to greater prescription adherence, meaning people properly taking prescription medication.

Safety Precautions for Laboratory Research With COVID-19 Specimens

Forte Research Systems®

Biosafety has surged to the spotlight due to the current COVID-19 global pandemic, motivating sites to conduct a risk assessment and develop a risk mitigation plan. General

To Life, Liberty and The Pursuit of Happiness

Pharma Packaging Solutions

We hope this message finds you and your family well. We have thought about you so much during these unique times. Our associates have been working around the clock to meet unprecedented demand due to COVID-19. Please know that our associates, with creativity and agility, are navigating this new normal and collaborating more than ever with customers to set a new standard of care and support.

COVID-19 Clinical Trial Updates

My Local Study

COVID-19 remains on the tip of everyone’s tongue, and with each state varying it’s reopening stances and policies, many wonder about vaccines and treatment options. But vaccines and treatments don’t just “appear” one day and are available for everyone. They go through a clinical trial process to determine a vaccine or treatment’s safety and effectiveness. Read more COVID-19 Clinical Trial Updates. The post COVID-19 Clinical Trial Updates appeared first on MyLocalStudy.com.

Crucial Data Solutions Forms Partnership with Durham Tech to Support Clinical Research Education

Crucial Data Soutions

Durham Tech’s clinical trials program utilizes TrialKit, a data collection and study management platform from Crucial Data Solutions. Left to right: Dr. William Gluck, Program Director; Jeff Rogers, CDS President; Bill Ingram, Durham Tech President. RENO, Nev.–(BUSINESS –(BUSINESS WIRE)–Crucial Data Solutions, Inc.

Blending the Power of CTMS with IBM Merge

Cloudbyz

Clinical Trials, slowly but surely are becoming the new talking point of our generation. Even the teenagers of this contemporary age were discussing and searching about the clinical trials over the internet. Many of the world’s powerful bureaucracies are closely monitoring the curiosity spinning around clinical trials. What’s the basis for such significance? The planet slowed to a standstill because of the COVID-19 and the global economy is at its highest peril.

Community means the world to Client-Pharma

Client Pharma

Client-Pharma is committed to providing a first-class service to clients all over the world, and closer to home they pledged to serve the local community that emulates their core company values. Since the UK lock-down began, Client-Pharma teamed up with a local restaurant to provide fresh hot meals daily for neighborhoods in a local town close to the office HQ.

Endocrine System Questions for Patients

DM Clinical Research

The endocrine system is one of the most vital parts of the body. But lots of patients don’t even know what this system does. If you have an endocrine disorder, then you might have painful, chronic symptoms. Below, we will answer some common endocrine system questions. This way, you can visit a doctor if you think you have an issue. What is the Endocrine System? What do you know about your hormones? Most people think they know the basics of their high school health class.

Our Commitment To You During COVID-19

Pharma Packaging Solutions

We are monitoring the COVID-19 situation very closely. We are confident we can abide by any imposed guidelines while continuing to seamlessly support our customers’ business operations. Because we care about our associates, our customers and our communities, we want to share the steps we are taking during this fluid and changing situation. We do have an active business continuity plan to keep our customers, our visitors, our associates and their families safe and healthy.

PwC Pharma & Life Sciences Webinar: COVID-19 impact on the ITX and regulatory DNA – Thursday 28. May 2020, 10:30 CEST

Pharma Business Blog

As the COVID-19 situation develops, tax and regulatory specialists within the pharmaceutical & life sciences industry are increasingly facing complex challenges. Efficient and pragmatic solutions have to be realised, with fewer resources, in line with the changing local legislation. The exchange of information is the best practice in this industry to support and inspire you in your daily business.

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REVIEW ON COVID -19(CORONA VIRUS DISEASE)

Pharma Tutor

AUTHORS : * Tinku Kumar Singh 1 , Satish Kumar 1 , Purna Tiwari 2 1 Indchemie health Specialities Pvt. Ltd 2 Alkem health science Ltd. tinku20190@gmail.com. . ABSTRACT : The World Health Organization (WHO) has declared the corona virus disease 2019 (COVID-19) a pandemic.

Clinical Trial Budget & Payment Management Solution Overview

Cloudbyz

[link]. Cloudbyz Budget management solution is an integrated end-to-end solution that enables all the stakeholders, ie Sponsors, CRO’s and Sites to gain visibility, control and flexibility in managing the financials across clinical trial projects. The solution helps in accelerating study budget management with a high level of accuracy and minimal manual effort. Check out our video to see how our solution can simplify your Trial Budgeting process.

Team Spotlight with Kalea Belso

Client Pharma

Kalea Belso is Client-Pharma’s Commercial Finance Manager, she is a great team member and always arrives with a smile on her face – even in our video team catch up’s. We took a moment to find out a little more about Kalea and get an insight into her role with Client-Pharma. What is your main day-to-day role?

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The Pharmaceutical-Biotech-Devices Industries Face a New World Post-Pandemic

Eye on FDA

There is going to be a time in the not too distant future, when the fuller picture of the healthcare impacts of COVID-19 come into sharper focus. When that happens, it is not likely to be pretty. In large part, this is because a very large portion of the population has moved into a state of unemployment.

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Update on COVID-19

Pharma Packaging Solutions

As the situation with COVID-19 continues to change, we wanted to let you know that Carton Service/Pharma Packaging Solutions is defined as an Essential Industry due to the life-sustaining products we produce. Even with communities establishing Shelter-In-Place or Safer-At-Home orders, our associates have been notified that they are essential workers. We have asked anyone who is feeling ill to remain at home.

OFAC fined US subsidiary of Austrian ERBER Group after misinterpreting US Sanctions

Pharma Business Blog

Animal nutrition company BIOMIN America was fined by more than $250’000 for coordinating sales of agricultural commodities to a company in Cuba without authorization from OFAC (US Office of Foreign Assets Controls). Instead of applying for the necessary OFAC authorizations for exports to Cuba, BIOMIN America developed a transaction structure involving their owned or controlled foreign entities. BIOMIN identified this structure as being consistent with the US sanctions regulations.

Repurposed Drug Tested in Covid-19 Trial, Thanks to Cancer Research UK Know-How

Drug Discovery Today

Cancer Research UK and its partners have today (Friday) launched a clinical trial to test if a drug that’s used to treat inflammation of the pancreas can help people with COVID-19

Enabling Your Remote Workforce

Cloudbyz

To Better Service Your Customer During the COVID-19 Pandemic. We thought of changing it up this week to share how our team is working with customers during these unprecedented times. With today’s capricious working culture, here are some practices we are implementing with our loyal customers: Click here to learn more about what Cloudbyz CTMS can do for your organization or request a virtual demo today. For more information, please e-mail us at info@cloudbyz.com.

What’s New Health Canada?

CATO Research

By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate. What’s New in: Therapeutic Products Directorate: [link] Biologics and Genetic Therapies Directorate: [link] Medical Devices: [link] Natural and Non-prescription Health Products Directorate: [link]. Updates from Health Canada. New Private Label Medical Device Licence Application Form. 07 April 2020.

The OK for Patients’ Return to Healthcare Needs Clear Signals From Trusted Sources

Eye on FDA

COVID-19 was a shock to the system unlike anything that had been anticipated. Even prior to the shutdown, health-perceptive people were starting to avoid public venues and there were declines in the numbers of people going out to eat at restaurants, to public functions, visiting with friends and also going to the doctor’s offices.