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Introduction to Digital Health in Clinical Trials QbD Group

WEBDigital technology is transforming the way clinical trials are conducted, offering new opportunities to improve patient experience, data quality, and trial …

Actived: 9 days ago

URL: https://qbdgroup.com/en/blog/introduction-to-digital-health-in-clinical-trials/

What is Digital Health

WEB2. Artificial Intelligence in digital health. The second pillar is Artificial Intelligence (AI).Artificial Intelligence is defined as any technique that enables machines …

Category: Health Go Health

Digital Health in Pharma: Revolutionizing the Industry

WEBPreviously, we dissected the digital health arena into 3 core domains: Pharma, Clinical, and MDs/IVDs, and identified 4 foundational pillars: blockchain, ML/AI, …

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Essential Documents in Clinical Investigations with Medical Devices

WEBThe investigator’s brochure (IB) is a compilation of the clinical and non-clinical information about the investigational device that is relevant to the investigation …

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What is a medical device

WEBAs you can see, some products – that were previously not regarded as medical devices – became medical devices according to the new ruling definition of …

Category: Medical Go Health

What is the GAMP 5 V-model in CSV

WEBThe GAMP 5 V-model describes the activities to be performed and the deliverables to be produced during product development. The name refers to the shape …

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QbD Group Quality partner for companies active in life science

WEBQbD is an international organization. Not only because of its offices across the globe (Belgium, the Netherlands, Spain, France, Mexico, Colombia, and many more), but its …

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Medical Device and IVD industry trends for 2023

WEB5 Medical Device and IVD industry trends. 1. Accelerated consumerization of diagnostics. Technological innovations are leading to more accurate, convenient, faster, …

Category: Medical Go Health

The Advent of Artificial Intelligence and Machine Learning in …

WEBNow, what is AI/ML used for in the medical field? A first observation is no surprise: MDs are vastly outweighing IVDs. The therapeutic area of radiology alone …

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SaMD versus MDSW: what’s the difference between Software as a …

WEBNowadays, digital healthcare is taking an increasingly important place in the medical world through medical software, image processing, diagnostic support, home …

Category: Medical Go Health

ILAP: the UK's Innovative Licensing and Access Pathway

WEBIn order to give patients quicker access to cutting-edge treatments and therapies, the UK government introduced a pathway in 2021 called “Innovative Licensing …

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Types of Medical Writing: Introduction to Medical Writing in …

WEBMedical Writing is generally defined in different types depending on the above mentioned factors. 1. Regulatory medical writing. Regulatory medical writing is …

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QbD and Inovigate launch Health to Market, a contract …

WEBHealth to Market is the place to be for life sciences companies, particularly in med tech, in different maturity stages.Whether you are a start-up ready to go to market, …

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CAR-T cell therapy: main components, production and prospects

WEBCAR-T cell therapy, a groundbreaking advancement in the pharmaceutical industry over the last 20 years, exemplifies the innovative strides made in areas like recombinant proteins, …

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Clinical Evaluation Report: must-have for all medical device

WEBClinical evaluation of a medical device – defined as an ongoing collection, generation, appraisal, and analysis of clinical data related to your device – is central to …

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A Complete Guide to Computer System Validation (CSV)

WEBThis guide aims to suggest the tools and strategies necessary and appropriate for use in the validation of computerized systems for (human and veterinary) Pharmaceutical …

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Annual Product Quality Review (APQR/PQR) in Pharma QbD

WEBCurrent regulations require written documentation for all existing products in the company; this documentation is known as the Annual Product Quality Review in …

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The key role of Regulatory Affairs in the pharmaceutical industry

WEBThe role of Regulatory Affairs in Pharma throughout the lifecycle of a medicinal product. Once the drug discovery phase, during which potentially interesting …

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7 key areas to focus on during internal or supplier audits

WEBThe following non-exhaustive list indicates where to focus on for internal and supplier audits: 1. Compliance with regulatory requirements. It is essential to ensure that …

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