This decade rang in the digital clinical trial initiative, with the first ‘virtual’ trial being approved by the FDA in 2012. This was Pfizer’s Research On Electronic Monitoring of Overactive Bladder Treatment Experience (REMOTE) trial. It used e-consenting, web and smartphone-based recruitment, the study drug was delivered to patient’s and patient data and patient safety were monitored remotely by physicians throughout the trial. The objective was to enrol 600 patients from about 10 states across the USA. However, the trial failed, primarily as recruitment targets were not met, owing to the f

Data can be used to analyze genomes, prescribe pharmaceuticals in the pharmaceutical and biotechnology industries, and a variety of other applications. Now that data has become "BIG DATA," analyzing it has become a whole new field of "Analytics and Data Science." The cost of genome structure analysis has decreased from ten million dollars in 2007 to one thousand dollars thanks to analytics. On the basis of big data analysis, a cancer treatment was prescribed. It can be used in a variety of industries and enterprises. There are numerous firms that are solely dependent on analytics, as well as

While the life sciences sector has incrementally adopted digital technologies over the years, the rate of digital transformation over the next five years looks to be unprecedented. Collaborations and acquisitions in the pursuit of digital transformation have accelerated significantly. In 2018, US$9.5 billion was invested in the digital health sector over 698 deals. From the FDA approval of Otsuka’s sensor embedded drug Abilify Mycite and the approval of Pear Therapeutics’ app for the treatment of opioid abuse, through to Takeda’s partnership with Emulate Inc for the use of organs on chips for

Pharmacovigilance (PV) is increasingly taking its toll on life science organisations. According to EY research1, large pharmaceutical companies contend with an average of 700,000 adverse event (AE) cases each year, a number that IDC2 has found to be rapidly increasing by 30 to 50 per cent annually. The pandemic has exacerbated the situation, with the fast tracking of COVID-19 vaccines increasing AE caseloads to more than one million a year for some industry players.Companies are under pressure to manage this increased case load effectively while still maintaining their current cost base. Data

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In the ever-evolving realm of pharmaceutical research and development (R&D), the powerful wave of digitalization is restructuring conventional methodologies and paving the way for a novel era of ingenuity and streamlined processes. Termed digital transformation, this profound shift entails the strategic infusion of cutting-edge information technologies into established drug discovery and development procedures. Leading this revolution are technologies like big data analytics, artificial intelligence (AI), blockchain, and telemedicine. Digital transformation signifies a potential revolution in

While the life sciences sector has incrementally adopted digital technologies over the years, the rate of digital transformation over the next five years looks to be unprecedented. Collaborations and acquisitions in the pursuit of digital transformation have accelerated significantly. In 2018, US$9.5 billion was invested in the digital health sector over 698 deals. From the FDA approval of Otsuka’s sensor embedded drug Abilify Mycite and the approval of Pear Therapeutics’ app for the treatment of opioid abuse, through to Takeda’s partnership with Emulate Inc for the use of organs on chips for

Artificial Intelligence (AI) and machine learning-based technologies have the potential to transform healthcare because they offer new and important insights derived from the vast amount of data generated during the delivery of healthcare every day. The capacity of AI to learn from real-world feedback and improve its performance makes this technology uniquely suited as Software as a Medical Device (SaMD) and is responsible for it being a rapidly expanding area of research and development. Clinical pharmacy practice may undergo major change due to the implementation of this technology. The cha

Controlling the industrial crystallisation process poses a significant obstacle in the production of drugs and numerous other products. Digitisation of the crystallisation process now allows for radical change by increasing process automation to control overall crystallisation. The main pillars of Pharma 4.0 are process automation, improved control strategies, data visualisation, cloud edge storage, chemometrics, and mathematical modelling technologies. SmartCrys is a revolutionary integrated process control system that harnesses the mainstays of Pharma 4.0 with the combination of PAT tools i

The cyber-physical security of any manufacturing system, specifically food and drug manufacturing, is essential. The technology in the pharmaceutical industry advanced significantly in last decade to improve upon every aspects of drug manufacturing. However, much less attention has been paid to identify and proactively mitigate the risk of cyber-physical attacks. Viruses that threaten these systems are very real and in recent years have proven very harmful and costly. Those that target drugs consumed by billions of people worldwide will inevitably have deadly consequences. Even with dedicated

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