April, 2020

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Three Keys to Preparing Effective Pre-IND Meeting Questions

Camargo

Asking the appropriate questions during a Pre-IND meeting with the FDA is a critical step. The post Three Keys to Preparing Effective Pre-IND Meeting Questions appeared first on Camargo.

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Automated Reports and Custom Dashboards

Drug Patent Watch

Let DrugPatentWatch build custom dashboards and reports to take the load off of your team. We can ensure the production of accurate, objective, and timely intelligence to help you quickly…. The post Automated Reports and Custom Dashboards appeared first on DrugPatentWatch - Make Better Decisions.

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Herd immunity won’t stop the outbreak: 3 Dangerous Covid-19 Myths

Find Me Cure

The spread of misinformation about Covid-19 can only be parallelled by the spread of the virus itself. This would all be in good humour (like the jokes about fighting the virus with alcohol) if it was not so detrimental to many people’s health and mental wellbeing. . Here at FindMeCure we have always been careful not to present hypotheses as facts and to spread awareness rather than myths and conspiracy theories.

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Contact Tracing Assessment of COVID-19 Transmission Dynamics in Taiwan

JAMA Internal Medicine

This study delineates the transmission dynamics of coronavirus disease 2019 (COVID-19) and evaluates the transmission risk at different exposure window periods before and after symptom onset.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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FDA Recommends Clinical Trial Sponsors Consider Virtual Visits

VirTrial

The FDA recently released new guidance on clinical trials in the face of COVID-19. In their published report, FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic , they acknowledged that challenges may arise in ongoing trials. For example, quarantines, site closures, travel limitations, etc. may lead to difficulties in meeting protocol-specified procedures including administering or using the investigational product or adhering to protocol-mandated visits and

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FDA Seizures of Mail-order Prescriptions Increase in the Time of Coronavirus

Pharmacy Checkers

Unbelievably, the FDA has increased seizures of international mail-order prescriptions over the past month. Historically, far less than one percent of personal medicine imports are taken away by the FDA, despite the federal restrictions on importation. I only believe this to be the case if the exporting pharmacy requires a valid prescription. I don’t know if the FDA is more aggressive with rogue pharmacy actors than with legitimate pharmacies.

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The Language of “Recovery” in the Age of COVID-19

Eye on FDA

There have been many parallels drawn between this pandemic and the AIDS pandemic that began in 1981. And in fact while many obvious differences exist there are many valid comparisons. Moreover, there are some common threads that run through crises involving a communicable disease and here were a few from this writer back in February 2020. But as many turn their attention to a “recovery” phase for this pandemic, there are also some lessons learned from the experience of HIV/AIDS that

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Has COVID-19 Become the Catalyst for Virtual Clinical Trials?

Crucial Data Soutions

The COVID-19 pandemic that struck the globe this year has drastically disrupted the state of affairs in the life sciences industry. Traditional methods of clinical data collection and trial management encountered change in mid-March as the FDA released guidance on conducting trials during the pandemic. In the guidance, the FDA emphasizes the importance of curtailing risk and further ensuring patient safety, and makes recommendations such as implementing a centralized or remote monitoring program

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List of Top 10 Pharma Franchise Companies in India

Fossil Remedies

Top 10 Pharma Franchise Companies in India. Irene Pharma. Irene Pharma – Being one of the prominent PCD Pharma company in India located at Ahmedabad Gujarat, we have faith in embracing new advances for consistently enhancing our PCD Pharma business operations. Fossil Remedies. Having headquarters in Ahmadabad, Gujarat, ‘ Fossil Remedies ’ is the top most Pharma franchises company in India with long years of experience.They manufacture and market more than 2800+ Pharma products and indulge

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Hybrid DCTs Reduce Dropout Rates in Long-Term Studies

VirTrial

Clinical studies are carefully designed to address the unique needs of not only the sponsor, but more importantly, the patients that commit to participate. Depending on the nature and severity of the condition, study lengths vary. A cardiovascular outcome trial (CVOT), for example, requires a long duration (potentially up to five years) in order to effectively evaluate real-life, long-term outcomes.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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What Does Covid-19 Mean for Patients in Clinical trials?

Find Me Cure

Many of you will be directly affected by this pandemic even if you never test positive for Covid-19. Some of you already are. The last couple of weeks had us write many emails to patients applying for clinical trials informing them that the trial they are interested in has been suspended. This is heartbreaking for the FindMeCure team because we started our company with one mission: to help patients find treatments. .

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How to Know if You Have a Compromised Immune System

DM Clinical Research

Do you have a compromised immune system? If you are worried about the coronavirus, then you have probably asked yourself this question. People with weaker immune systems are at a higher risk for COVID-19. Knowing the right information about your health will help you to protect yourself during this pandemic. We will explain what it means to have a compromised immune system below.

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Customer Success: Formulary Management

Drug Patent Watch

In response to customer requests, we’ve built some new tools for formulary management. You can preview these tools at: Recent Generic Drug Launches Upcoming 180-Day Patent Challenge Exclusivity Expirations Anticipate…. The post Customer Success: Formulary Management appeared first on DrugPatentWatch - Make Better Decisions.

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PharmacyChecker Online Pharmacy Authentication Role Recognized in OECD/EU Report on Counterfeit Drugs

Pharmacy Checkers

When I read fancy-looking international reports that address the problem of counterfeit drugs, too seldom is our work recognized in verifying international online pharmacies in a manner that saves the lives of consumers looking online for affordable medicine. To some extent, that’s because the global pharmaceutical industry is often a major data source for these reports.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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Google Translate: The Unwitting Confidentiality Flaw

Imperical Blog

The Information Age has impacted a wide range of industries and workplaces. The translation industry has been no stranger to technological advancements, predominantly with the introduction and ever increasing use of machine translation. The most renowned translation software is Google Translate. Launched in April 2006, Google Translate has become a household name, boasting capabilities in 103 languages.

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Impact of COVID-19 on FDA Enforcement and Approvals – Part 5 – FDA Provides Update to Shape Expectations on New Approvals

Eye on FDA

In response to written questions submitted last month regarding the potential for delays, FDA had stated that “ CDER remains fully capable to continue daily activities, while responding to the public needs of the current COVID-19 outbreak. ” In a subsequent blog posting this month, it was noted that FDA was devoting personnel to focus on COVID-19-related review efforts and that it was certainly possible that this might be a factor in delaying new approvals of non-COVID-19 medicines a

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5 Telehealth Providers to Rely on During Covid-19

Find Me Cure

Telehealth services have been around for a while now but it wasn’t until the Covid-19 epidemic that they became such a necessity. Although a lot of you express such bravery in the face of what is going on in the world, many are rightfully concerned for their health. . Especially if you are someone in the risk group – if you have an autoimmune disease, a respiratory disease, are over the age of 60, etc. – this is not the best time for you to visit the hospital.

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10 years in 10 days: the new global digital health paradigm in life sciences

pharmaphorum

COVID-19 is making digital transformation even more pressing for pharmaceutical companies. Amid the coronavirus pandemic digital health offers many ways to develop public utility projects and enhance healthcare communications.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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Getting Clinical Research Job During Covid 19 Pandemic

ECRG Media's Clinical Research Podcast

Getting Clinical Research Job During Covid 19 Pandemic 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 » Educati

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Will you change your supply chain to benefit from a VAT and duty free importation into Belgium?

Pharma Business Blog

As an effort to limit the impact of COVID-19, the Belgian government has introduced a temporary relief measure whereby certain goods imported into Belgium can benefit from a VAT and duty exemption. A key condition to benefit from said exemption entails the importation by a so-called recognized healthcare institution (almost all Belgian hospitals qualify as such an institution).

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Need of online pharmacy during covid-19 lockdown

Pharma Tutor

The global Online Pharmacy market is anticipated to rise at a considerable rate. The consumers are preferring to purchase medicine online due to covid-19 lockdown. Governments are taking all essential steps for protecting lives by imposing lockdowns, testing, segregation, and treatment. At the same time also restricting outdoor movement except for supplying and procuring essential goods and services.

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T-Minus COVID-19 – Impact of Pandemic on New Medicine Launches

Eye on FDA

As the coronavirus pandemic began to unfold, focus on the pharmaceutical and biotech sectors was on the most immediate and apparent concerns – the impact on the supply chain for drugs that are currently in the market and on the regulatory process for approving new ones. More distant in time, but also of extreme importance is the effect on the launch of new medicines that have been approved.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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How to Apply for A Clinical Trial On FindMeCure

Find Me Cure

With 85% of patients unaware of clinical trials as an option at the time of their diagnosis, according to the NIH , it’s a shame that many parts of the application process are still needlessly complicated when a patient is aware and motivated. FindMeCure was founded with the mission of spreading awareness and making the process of finding and applying for a trial easier on patients. .

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1000th Meal Delivered to the Local Community

Client Pharma

Client-Pharma has been funding meals to deliver within their local community since mid-March and this weekend, the team delivered their 1000 th meal. Client-Pharma wanted to do everything they could to help their community during this these difficult times. The company joined The Three Horseshoes restaurant in Barton-under-Needwood, to deliver a free hot meal service to local residents that are vulnerable and continue to remain in self-isolation.

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Getting Clinical Research Job During Covid 19 Pandemic

ECRG Media's Clinical Research Podcast

Getting Clinical Research Job During Covid 19 Pandemic 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 » Educati

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Vaccines trials in the COVID-19 era and tech’s role in speeding studies

pharmaphorum

This pharmaphorum webinar will take place on 8th April and comes as the COVID-19 outbreak has exposed the challenges pharmaceutical companies face as they race to develop a coronavirus vaccine. Thrown into even sharper relief than usual are the needs faced by all vaccine trials to balance study speed, data accuracy and patient experience. Additionally, given the fear of exposure and city mandates for individuals to stay at home, traditional patient recruitment challenges are exacerbated for a co

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

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SHOULD WE CUT BACK ON CAFFEINE?

Pharma Tutor

AUTHORS : P.Tulasi, M.Akshara, M.Manisha Reddy, M. Hiranmai, M. Anusha Reddy. Sarojini Naidu Vanita Pharmacy Maha Vidyalaya, Hyderabad. ABSTRACT : We aimed to explore on different effects of ingestion of caffeine. We mainly focused on the advantages and disadvantages of caffeine ingestion along with healthy dosage and alternative for caffeine. We conclude that ingestion of caffeine may acutely improve muscle strength and provide significant health benefits for training men (Athletes).

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Great news for Swiss Medtech companies – Postponement of the application date of MDR

Pharma Business Blog

In one of our previous posts we draw your attention to the upcoming deadline of May 26th, 2020 which was the date on which the MDR, i.e. the new EU regulation concerning medical devices was expected to be fully applicable. Due to the still ongoing discussion between Switzerland and the EU with respect to the Mutual Recognition Agreement (MRA), which until now granted a special position to Switzerland also with respect to the access of the EU medical devices market, it was expected that May 26th,

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Touchlight appoints Dr. Helen Horton as Chief Research Officer

Drug Discovery Today

Former J&J Senior Scientific Director and immunology expert joins at a pivotal time.

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Team Spotlight with Terry Howard

Client Pharma

Terry Howard is Client-Pharma’s Quality Manager, and his wide experience and management skills help to maintain our network of clients and supply partners all over the world. We took a moment to find out a little more about Terry and get an insight into his role with Client-Pharma. What is your main day-to-day role? I feel really lucky that every day is diverse, and that I am playing my part in reaching the wider business objectives of Client-Pharma becoming the world leader in commercial drug (

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.