DRUG, DEVICE INDUSTRIES, PATIENT GROUPS DIFFER ON OFF-LABEL COMMUNICATIONS

BRONWYN MIXTER | May 3, 2017

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The drug and medical device industries want the FDA to allow them to give more information to payers and health-care professionals about off-label, or unapproved, uses of their products to help them make decisions.

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PureCare

One of the many challenges of the modern world is to help people with mental health problems. That’s what PureCare is here to do. Based in Gillingham in Kent, PureCare has been registered with the Care Quality Commission since 2006 and gained 3 stars (under the old inspection standards) within 18 months of opening. Since then we have been awarded an “Excellent” Quality and Risk profile under the new standards in 2010.

OTHER ARTICLES

WANT LESS “LIABILITY” AND MORE “RELIABILITY” FROM YOUR CLINICAL MOBILITY SOLUTION?

Article | March 2, 2020

I recently discussed the different ways that consumer-grade smartphones can compromise patients’ health, safety and overall care. However, some clinicians and healthcare administrators have indicated in recent months that they need help selecting the right enterprise-grade mobility solutions for their unique operating models and workflows. There are many different hardware and software options, and a single rugged device can come in multiple configurations. So, how do you know if you’re picking the right communication tools for your clinicians? The key is to first set performance expectations for the total mobility solution rather than the device alone.

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Decentralized Clinical Trials: Imperative for Pharma Sector to fight COVID19

Article | March 2, 2020

These are unprecedented times. The world is mobbed by a contagion virus, putting people’s health at risk, threatening to destabilize economies. It has already put global healthcare systems under tremendous pressures, and managed to resist efforts to contain it. Even though coronaviruses are not new, this COVID-19 strain has created panic and forced us to be locked down in our homes sans any movement for weeks, if not months. Organizations are fighting an intense battle to keep their workforce safe, minimize risk, and ensure business continuity. For the Life Sciences industry, however, the challenge is even more significant. The whole world is looking at them to come up with a vaccine and a cure. But that is easier said than done. Bringing a new drug to market is an uphill battle and requires rigorous clinical trials. This process already has regulatory challenges. With the current lockdown situation, the Pharma community is grappled with the challenge of continuing some of the critical and time-sensitive in-flight trials so that their regulatory submission, registration, and market entry are not impacted. But all may not be lost. With the right technology solution, it is possible to turn the situation around rapidly.

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PHARMACY MARKET

A pharma outsourcing mission

Article | March 2, 2020

In a way, getting through the initial stages of a complex pharmaceutical project that is being outsourced to a contract development and manufacturing organization is like getting a rocket off the ground. Many drug developers express frustration with the time it often takes during the initial stages of working with a CDMO — from the time they first reach out to a CDMO for help until they receive a proposal. Some have described it as months of silence from when they send a request for proposal (RFP) until they have a proposal in hand. The initial stages of a relationship between drug sponsor and CDMO often do not get the attention it deserves, and valuable time is lost, delaying projects and delaying delivery of therapeutics to patients. The quick scheduling of the ACT meeting with the right attendees can deliver immediate answers to key questions needed by the drug sponsor for effective planning and can help propel projects to a successful launch.

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How AI and Big Data Will Disrupt Pharma’s Regulatory Compliance Standards

Article | March 2, 2020

The industry as we know it is changing. Pharmaceutical and life sciences companies across the globe are experiencing more pressure than ever to keep up with increased regulatory standards while moving at a pace that requires them to innovate in order to remain competitive. With more real-time automation and the steady increase in AI and Big Data sweeping the landscape, what used to be a slow-to-change and risk-averse industry is now expected to see a significant shift towards newer technology that focus on heightened regulatory standards. Here’s how your company can get ahead of what industry experts are calling, Pharma

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Spotlight

PureCare

One of the many challenges of the modern world is to help people with mental health problems. That’s what PureCare is here to do. Based in Gillingham in Kent, PureCare has been registered with the Care Quality Commission since 2006 and gained 3 stars (under the old inspection standards) within 18 months of opening. Since then we have been awarded an “Excellent” Quality and Risk profile under the new standards in 2010.

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