DRUG DEVELOPMENT QUESTION? HERE’S HOW TO COMMUNICATE WITH THE FDA

| January 14, 2016

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Earlier this month FDA (CDER and CBER) issued a new draft guidance, Best Practices for Communication Between IND Sponsors and FDA During Drug Development. Based on Camargo’s frequent communications with the Agency during product development.

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Gold Biotechnology, Inc.

Gold Biotechnology shares a vision with every researcher: Each facet of life science research will introduce us to a future of impactful discovery and learning, benefitting the entire world. And our vision will materialize sooner if a researcher’s passion is not sullied by worry over the quality of their reagents, especially the cost for quality. This is why we’re here! We believe in a future of change and prosperity, and we want to help you get there by being a resource for high-quality products at exceptional prices. By providing our customers with only the best chemicals possible, tested in GoldBio labs to assure our own quality specifications are met, you can be sure your research will go off without a hitch.

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Global clinical guidelines have shifted the industry toward risk-based approaches for the planning and execution of clinical trials. The ICH’s guidelines for Good Clinical Practice state that sponsors should evaluate identified risks against existing risk controls by considering “the likelihood of errors occurring, the extent to which such errors would be detectable, and the impact of such errors on human subject protection and reliability of trial results” (ICH E6 R2).

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Artificial intelligence in pharma: utilising a valuable resource

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Decentralized Clinical Trials: Imperative for Pharma Sector to fight COVID19

Article | March 20, 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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Pharmacist eCare Plan - the newest disrupter in health data exchange?

Article | March 20, 2020

Every member of the health care team shares a common goal of optimizing patient outcomes. Yet each specialty and position of the healthcare team has a unique workflow facilitated by various tools, from an operative report to a progress note. In this regard the pharmacist plays a pivotal function in medication management and requires documentation specific to that role. The Pharmacist eCare Plan (PeCP) allows for an interoperable note to be used in the pharmacy to assist in the exchange of patient information, including active medication list, laboratory results, and payer information. To allow for this, a new type of clinical document architecture for the PeCP was created and standardized for use across pharmacies.

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Spotlight

Gold Biotechnology, Inc.

Gold Biotechnology shares a vision with every researcher: Each facet of life science research will introduce us to a future of impactful discovery and learning, benefitting the entire world. And our vision will materialize sooner if a researcher’s passion is not sullied by worry over the quality of their reagents, especially the cost for quality. This is why we’re here! We believe in a future of change and prosperity, and we want to help you get there by being a resource for high-quality products at exceptional prices. By providing our customers with only the best chemicals possible, tested in GoldBio labs to assure our own quality specifications are met, you can be sure your research will go off without a hitch.

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