Disrupting the Clinical Research Industry by Merging Clinical Trial Software Development and Clinical Trial Delivery
“More and more major businesses and industries are being run on software and delivered as online services—from movies to agriculture to national defense. … Over the next 10 years, I expect many more industries to be disrupted by software ...”
Designing and running clinical trials is very complicated and expensive, and in many ways, each trial is unique. However, by applying general manufacturing principles and thinking, it is possible to distill out those processes that are common to all trials and show their interconnected nature, both operationally and mathematically. This approach allows clinical trial performance to be characterized by a limited number of independent variables, and clinical trial performance to be optimized so that the clinical trial "manufacturing line" produces its "final product", clean data, in the quickest, and most cost-effective manner possible.
Patient support programs (PSPs) and market research programs (MRPs) are popular and, in some areas, expected services of the pharmaceutical industry that place a significant burden on pharmacovigilance (PV) resources. PSPs are designed to enhance patient safety and help patients and/or healthcare professionals to better manage disease and optimize treatment.
As the pharmaceutical and healthcare industry drive towards developing effective medicines and delivering total solutions for patients, they are trying to leverage new business modes and technologies from other industries to meet changing needs across geographies, patients, providers and regulators. AI supported ‘Digital’ technologies can allow innovative, connected, efficient and savvy adopters to surge ahead in their transformational journey.
Artificial Intelligence has been around for a while, but a relatively recent openness exhibited by the drug and device regulators has opened doors for exploring the cognitive concepts and robotics across the pharma value chain. The FDA had recently embraced devices for detecting diabetes and predicting chances of a stroke both based on application of cognitive technology.
The global life sciences industry is transforming at breakneck speed. At the forefront of the transformation is an increased focus and scrutiny for quality and compliance by global regulatory authorities, the race to find cures for rare diseases by accessing relevant patient cohorts, and to top it all, intense global competition.
Labeling is an important mechanism for communicating safety and benefit-risk information to patients and healthcare professionals. Labeling errors could pose a significant risk to patient safety, resulting in an instance of regulatory non-compliance.
Denis Fung, Head of Regulatory at Navitas Life Science, asks is labeling the next area ripe for outsourcing and discusses how labeling is an important mechanism for communicating safety and benefit-risk information to patients and healthcare professionals.
Wide-ranging factors like rising R&D costs to pricing pressures, and increasing regulatory burden to tax reforms in different countries have created an irrefutably perplexing innovation and commercial environment for pharma companies. Hence, they are increasingly looking at automation and digital technologies to reimagine their current strategies across the value chain.
October is national cyber security awareness month, says the United States Food and Drug Administration — an initiative that affects not just medical device manufacturers but also consumers and patients, as pacemakers, insulin pumps and entire hospital systems have been found vulnerable to threats lurking in the internet or from hackers outside the system.
Ram Yeleswarapu, President of Navitas Life Sciences and President and CEO of parent company TAKE Solutions, is featured in CIO Review. Ram talks about Navitas Life Sciences’ OneClinical™ technology platform and how the company drives successful outcomes for global trials by ensuring better trial oversight, delivering high-quality aggregated and integrated data in near real-time, enabling faster decision making and minimizing risks to trial success.
THE life sciences industry is transforming. Increased focus and scrutiny for quality and compliance by global regulatory authorities, prevalence of rare diseases and access to relevant patient cohorts, and fierce competition for market share on a global playing field are some of the factors driving this transformation. Additionally, the need to respond to pricing pressure while substantiating the proof of a product’s effectiveness in curing a disease condition is forcing companies to achieve greater efficiencies while doubling up on R&D efforts. All these factors are forcing pharma organizations to reexamine their portfolios, product development strategies and technology implementation models to ensure patient safety while overcoming drug shortages and maintaining affordability of life saving drugs.
Pharmacovigilance in 2020 – future horizons and efficiencies in data acquisition, evaluation and risk management
To manage the ever increasing volume of information, companies have turned to cost-effective resources. Jeffrey Ho, Principal Consultant, Navitas Life Sciences, highlights how the advent of technology will contribute to a more sustainable model of pharmacovigilance
Faster decision making and better trial oversight at all levels requires truly next generation data integration and analytics. Source and format agnostic data aggregation aided by modern data lake architecture and advanced analytics deliver interactive visualizations to identify new signals, discover hidden insights, minimize risks to trial success enabling data-driven faster decisions and successful outcomes.
Indian drug cos scramble to comply with new data regulation in EU, the second largest market for exports
EU is second largest destination for pharmaceutical exports constituting about 12 percent of total Indian pharmaceutical exports of USD 17.27 billion in 2017-18.
Artificial Intelligence (AI) will significantly transform or impact the life sciences space. This along with robotics and cognitive technologies is important to better outcomes, safety, and compliance and lower costs, stated Ram Yeleswarapu, president and CEO, TAKE Solutions Limited.
Technology advancement brought paradigm shift in Clinical Trial design, execution and management. Despite technology advancement and regular monitoring, the clinical trial industry and regulatory agencies are facing new challenges and fail to enhance patient safety.
Life Sciences executives are realizing that supply-chain improvement can not only lead to significant increases in shareholder value, but it can provide competitive advantage in sales channels and accelerate the launch of new products through to profit.
The success of innovator biologicals with downsides of high costs and patents expiring have contributed to development of Biosimilars coupled with advantage of regulations, adaptability by physicians and patients. Biosimilars being complex molecules need to have sound scientific strategic approach to development, manufacturing and research. Few legal issues have not dampened Biosimilar companies to have strong pipelines, quality and focused timelines to provide affordable and effective drugs to patients in need.
The global healthcare industry is primed for disruption and the use of SMAC (Social, Mobile, Analytics, and Cloud technologies) are poised to drive this revolution. The age-old adage that ‘prevention is better than cure’ could not have been more relevant today. It is true that developed nations spend an insignificant amount on preventative healthcare and the focus is more on cure.