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Functional service has been ranked high among the buzz words of the clinical research industry. Both sponsor organisations and service providers are equally excited about the opportunities this model offers and the potentially win-win situation it provides to them. Sponsor organisations typically send individual protocol-related service RFPs (request for proposals) to CROs and follow-up with contract negotiations. Sponsors have realised the benefits of reduced oversight and contract management a complete functional service outsourcing model offers saving valuable time and resources. Depending
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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
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To bring this into reality, pharmaceutical PV organisations need to move into a “digitalised future” where technology plays a key role in PV processes. This includes automating and streamlining the information streams to reduce complexity, from case processing to reporting. Once automated, companies need to begin to look to artificial intelligence to add further value from their data.

By applying artificial intelligence (AI) and data science approaches, organisations can turn the overabundance of data from being a challenge to solve, into an opportunity. A well-designed, automated, AI-powe
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Clinical research technology platforms have also emerged, providing participant-facing apps and websites where you can build in or interface with some or all the previously mentioned solutions, as well as expanding to other research-related activities such as virtual training, electronic informed consent form (eICF), participant recruitment, engagement, visit reminders and concierges, etc. Implementing these platforms, the individual participant is given an even more active role in their own research journey, as they are responsible to enter their own subjective data directly into the designa
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Clinical trials are an essential part of the development of new medical treatments and procedures, and they help to ensure that new interventions are safe and effective for patients above all. Because of that, it is really important that all steps in that process were done with special attention to patient safety above all, but also to the accuracy of data that is often still collected manually, which slows down the entire process, and sometimes even compromises it, which result with the fact that clinical trials are exposed to frequent audits precisely for this reason.
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Pharmaceutical companies are faced with the challenge of effectively managing and analyzing large volumes of data, which come in various formats, in order to extract meaningful and actionable insights. This is crucial for efficient drug development that balances cost and effectiveness. The use of cutting-edge technologies can help uncover the mechanisms of diseases, optimize clinical trials, and improve production efficiency and accuracy. By utilizing data analytics and automation, pharmaceutical companies can optimize their manufacturing processes and ensure timely and reliable delivery of d
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Nanomaterials have been one of the most exciting scientific and technical innovations of the past few decades. Due to their very high surface to volume ratios, they exhibit properties that can differ dramatically from those for the same material in bulk. This, and their ability to be designed and synthesized with multiple surface functionalities, has seen them used for a myriad of bespoke applications in industry and medicine.

Their medical applications span delivery systems for drugs, proteins and DNA/RNA to diagnostics, targeted cancer treatments, to theranostics. They have been used ver
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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
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Similar to the restrictions provided under HGRAC Regulation, the Biosecurity Law confirms that foreign persons are generally prohibited from collecting or preserving HGR in China or providing HGR abroad. Foreign persons will have limited rights to acquire and/or use China’s HGR through scientific research activities conducted in collaboration with Chinese entities but only with the prior approval of China’s Ministry of Science and Technology (MOST). The only exception to the requirement of obtaining approval is for clinical trials conducted through international cooperation at clinical trial
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It’s been nearly two years since the outbreak of COVID-19 began and we’re still in the midst of enormous disruptions to the world’s economies, businesses, education, and people’s lives. The pharmaceutical industry has been particularly disrupted. Previously, pharma companies suffered from a bad reputation. But following the emergence of the pandemic, they were thrown into the spotlight, suddenly having an important voice on the health of the world. Leaders in the pharma space were on the front cover of every newspaper and magazine not because of scandal, but because of the lifesaving treatmen
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The drug business has various strange qualities that make it very different from individuals' thought process of as industry. Its additionally an industry packed with logical inconsistencies; for instance, notwithstanding the undisputed reality that for more than a century the business has made a major contribution to human prosperity and the decrease of chronic sickness and suffering, it is still routinely recognized bygeneral society in assessment reviews as one of the most un-confided in ventures, frequently being contrasted horribly with the atomic business. It is without a doubt perhaps
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The Global Biosimilars Market is estimated to reach US$240 billion by 2030, with the Indian market at US$35 billion. The considerable increase in reference products, with the USFDA adding 90 molecules and India approving 70 biosimilars, promises to usher in further growth. The Biopharma industry seems keen on investing in the biosimilar market with a focus on improving healthcare and health care costs for diseases of interest like COVID-19, cancer, immunologic diseases, and diabetes. This is evident in the projected growth of the oncology biosimilar market at 17 per cent CAGR, and the growing
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The Indian pharmaceutical industry has seen an exponential growth in the field of fill finished dosage forms, especially generics but the future lies beyond generics in the field of complex generics, biosimilairs, vaccines and New Chemical Entities (NCE)/New Biological Entities (NBE). Developing NCEs and NBEs will position Indian companies in the ivy league of global innovators. Risk adverseness, lack of perseverance and complex, long regulatory approval process are impeding Indian pharma companies to venture into NCE/NBE research. Product portfolio expansion into complex generic injectables
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More than one billion people are impacted by chronic and acute lung diseases globally Infact, non-communicable diseases, such as chronic respiratory diseases are among the biggest reasons for fatality (WHO). Despite the growing health and wellness centricity across countries, respiratory conditions have not received the attention they need. If at all they do then it’s more for infectious conditions like Tuberculosis. But when wellness is looked at holistically, healthy lungs and lung health is paramount for overall health and wellbeing. According to WHO, respiratory illnesses lead to over 10p
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Extensive research, led to the understanding that small noncoding miRNAs played an important role in fine-tuning the genome. Complex networks in the brain are formed by the usage of transcriptome in wide range of combinations. Modulation of expression of thousands of genes is achieved by specific miRNAs controlling the target mRNA expression, leading to various physiological processes. Primary transcripts of miRNA are synthesised by RNA polymerase from miRNA genes. These transcripts are processed in the nucleus by the Drosha enzyme to produce a hairpin-like precursor miRNA (premiRNA). The pre
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Menarini Biomarkers (A. Menarini Biomarkers Singapore Pte Ltd) was founded with the mission of identifying, developing, and validating new biomarkers on circulating human cells for applications in diagnostics.

There is a current healthcare gap in precision medicine surrounding the fields of early disease prediction and disease control, particularly related to precision rare-cell isolation, analysis, and disease diagnosis. Menarini Biomarkers uses single-cell analysis to provide clinicians with new tools for early detection, tracking disease progression, and the measurement of real-time res
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In recent years, the United States has witnessed a remarkable phenomenon in the pharmaceutical industry: the departure of several major generic pharmaceutical manufacturers. The rationale behind this exodus is a subject of great interest, as it potentially carries profound implications for the nation's healthcare system and economy. This article attempts to delve into the reasons why these generic pharmaceutical manufacturers are moving their operations away from the US, exploring key factors such as regulatory challenges, intellectual property protection, cost pressures, and emerging interna
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Now more so than ever, biotechnology companies face resource constraints and the perils of drug devel-opment. Strategic partnerships, fostering synergistic growth, become crucial. This article explores diverse partnership models, from licensing to equity, beyond mere finances. While replete with benefits, challenges like intellectual property and cultural disparities persist. Effective communication and shared vision are vital, making these collaborations a potent force for accelerated innovation in advancing medical science.
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In the ever-evolving landscape of the European pharmaceutical industry, this article offers a comprehensive analysis of the strategic initiatives shaping the sector. From navigating regulatory complexities to exploring market trends, healthcare infrastructure, and digital transformations, we delve into the multifaceted forces steering this dynamic terrain. By dissecting key aspects such as pharmaceutical innovation, market access challenges, and the shift towards patient-centric healthcare models, this exploration aims to provide readers with a roadmap through the intricate tapestry of Europe
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Today there are more than 10,000 known rare diseases, defined by the European Union as conditions that affect less than 1 in 2,000 people and by the United States as those that affect fewer than 200,000 people. The vast majority of rare diseases are caused by or associated with detrimental mutations in protein-coding genes, making them prime candidates for correction with novel gene therapies and other gene-based medicines. Thanks to scientific advances in genetic engineering technologies over the last 20 years, clinical trials testing gene therapies and other gene-based medicines are more co