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    Home > Medical News > Latest Medical News > Aiming at the nearly 100 billion CRO market, he used AI to dig deep into real-world research, so that pharmaceutical research and development into the "autonomous driving" era.

    Aiming at the nearly 100 billion CRO market, he used AI to dig deep into real-world research, so that pharmaceutical research and development into the "autonomous driving" era.

    • Last Update: 2020-08-12
    • Source: Internet
    • Author: User
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    Guide: In the face of talent shortage, data processing difficulties and other industries pain points, AI has become a killer.
    March 26, China's first medical device using real-world data in China was approved for market, which means that real-world evidence in China can already be used as one of the sources of clinical evaluation for medical device registration approval.
    the "4 plus 7 band procurement" "two-vote system" and other multiple policy catalysis, pharmaceutical companies with real-world research capabilities of CRO enterprises have a more urgent need.
    and facing the shortage of talent, data processing difficulties and other industries pain point, AI has become a killer.
    in the 1960s, the infamous "reaction-stopping" infant malformation on the European market led to the initial market launch of the "salidomine" drug, which was first marketed to suppress pregnancy responses.
    37 years after the results, thalidomide was re-listed as a special drug for leprosy and multiple myeloma, with global sales of $9.685 billion in 2018, making it the highest-selling orphan drug.
    better known for being used to treat eye diseases such as glaucoma, it was later launched with eyelash growth agents, with global peak annual sales of more than $500 million.
    from everyone's "poison" to anti-cancer drugs, from eye drops to "beauty gods", thalidomide and bi-mapropylamine as the most classic interpretation of the old drug, and these are inseparable from the real-world evidence in the drug to increase new indications, new applicable groups and other provided effectiveness and safety data.
    real-world evidence from Real World Research, which can be used as a basis for clinical decision-making, providing market access evidence, and realizing new and expanded adaptation certificates for older drugs, has received widespread attention.
    but with the RCT (Random Ized Trial randomized controlled trial) study, more complex data dimensions, larger sample sizes, and more complex quality control systems make traditional CRO enterprises unmanageable and unmanageable in the face of RWS, and market demand is far from being met.
    Zhang Hongliang is a master's degree in China Medical University, has 12 years of experience in drug research and development in the clinical research industry, deep understanding of industry pain points, and at the end of 2016 to create remote medical technology, unique path, deep-dive industry pain points, focus on phase IV clinical and post-market large sample size research, through artificial intelligence to solve data collection and processing problems, significantly reduce costs, improve data quality, open the "AI-CRO" era.
    the core team with an average clinical experience of more than 15 years to allow remote medical technology to have a deeper industry understanding, coupled with the first two years of advantage, remote medical technology has become the industry recognized as the only AI-CRO company, and quickly completed the commercialization of products landing, signed more than dozens of pharmaceutical companies, CRO and so on.
    July 2019, Remote Healthcare Technology completed tens of millions of RMB A round financing spent on Huaying Capital and leveraged the expertise of investors to jointly explore the solution of wearables as a source of real-world data collection.
    multiple policies to activate real-world research real-world research under the influence of policy, market and other factors finally ushered in the spring.
    January 7, 2020, the National Drug Administration issued The Guidelines for The Development and Evaluation of Drug Development and Evaluation by Real World Evidence (Trial), which provideguidelines for evaluating the effectiveness and safety of drugs using Real World Evidence (RWE).
    then on March 26 this year, China's first use of real-world data glaucoma conduction tube was approved for listing, which means that real-world evidence in China can already be used as one of the sources of clinical evaluation for medical device registration approval.
    the recognition of domestic policy has greatly stimulated the development of the real-world research industry, which is of great significance, but also pointed out the new direction of business development for the whole CRO industry.
    as early as April 2019, real-world data on male breast cancer was first used in the United States for FDA drug approvals, overturning global perceptions of traditional drug reviews.
    the international market, began to pay attention to real-world research.
    2018 domestic pharmaceutical industry sales revenue reached 3.7 trillion yuan, the pharmaceutical industry in research and development and sales investment of about 50%, and real-world research can not only improve research and development output but also improve sales efficiency, the future development prospects are huge.
    coupled with the state to encourage innovative drug research and development and "4 plus 7 band procurement" "two-vote system" and other policies promulgated and implemented, pharmaceutical companies urgently need to have real-world research capacity of CRO enterprises to meet the "old medicine new use" "pharmaceutical marketing transformation" and other needs.
    estimates at a compound annual growth rate of 30%, real-world research is expected to exceed 100 billion in 2025.
    but the industry pain points of real-world research are still evident: the first is the high cost of research and development.
    traditional CRO business focuses on the pre-market stage of drugs, with small sample sizes and rcT randomized controlled trials.
    and the clinical IV phase of drug market, drug economics evaluation and other studies often from 3000 samples jump, if continue to follow the RCT this highly dependent professional research method, pharmaceutical companies simply can not afford high research and development costs.
    " CRC market price is 150-200 yuan / hour, CRA market price is 300-500 yuan / hour, high talent costs and in short supply. The second
    " is the surge in data processing difficulties.
    in terms of quantity, the data generated by the large sample size and the large sample size study in the real world study is about 100 times that of the RCT study, and from the qualitative point of view, the data dimensions of the real world study are more diverse, the channels are more complex, the cleaning is more difficult, and how to analyze and filter out more valuable conclusion information in the massive data is a big problem.
    in the face of these pain points, the domestic CRO production relationship began to evolve from a complete reliance on professional labor 1.0 model to information technology and professional crowdsourcing 2.0 mode: on the one hand, the information system began to act as an auxiliary work tool.
    2012 Zhang Hongliang co-founded the well-known domestic SMO (Clinical Research Field Management Organization) company as one of the founders, and built a technical team to develop a clinical research site management system for remote team and project management, improve project management quality and implementation efficiency.
    " but can only improve human efficiency by about 20%, not enough to solve the industry's large number of talent gap.
    " on the other hand, there is also a "drop-by-bit model" of the crowd-sourced platform, professional and scarce talent in the platform sharing, a certain degree of increased productivity of the industry.
    1.0 model improves the industry's management efficiency through professional management systems, and 2.0 systems improve connection efficiency.
    remote-collar medical technology is through artificial intelligence for individual execution efficiency of more than 10 times the enhancement, and then absorb the advantages of the first two modes to solve the traditional CRO cost structure can not solve the industry pain point, "AI-CRO" "autonomous driving" 3.0 model began to appear.
    entered the era of "autonomous driving" in pharmaceutical research and development China's CRO started late, in 1996 only appeared the first real CRO.
    but low human and material costs, a large patient population and a rich disease spectrum provide the soil for the development of CRO.
    24 years, with China's drug regulatory policy tightening, the promotion of a series of drug reform policies, domestic pharmaceutical companies research and development investment, clinical CRO market size also rose, more than 500 foreign enterprises, joint ventures, local CRO enterprises to support the market boom.
    became the first domestic CRO company to go public in the United States in 2007.
    2012, Tyger Pharma was listed in China, becoming the first domestic CRO company to be listed on a Share.
    but can not be ignored is that the domestic CRO development concentration is very low, in addition to foreign giants and a few local enterprises, small and medium-sized CRO enterprises can only take a small and beautiful development path, for a single link to provide services, it is difficult to form a large-scale operation. The reasons behind the
    , in addition to clinical trialpatient recruitment and management process to be perfected, more important is that there is no mature clinical talent training model, clinical trial design and management talent shortage, people as the core of resources to limit the development of the CRO industry.
    remote medical technology CTO Hu Qixuan in the artificial intelligence big data activities, Zhang Hongliang got to know the main artificial intelligence natural language processing direction of Hu Qixuan, and then Hu Qixuan as CTO joined the team.
    with the addition of technology, remote medical technology decided to use AI to completely replace human problems through part of the link, no longer limited to a certain link, but the Application of AI technology throughout the CRO industry chain, improve the efficiency of data collection and management of clinical research and reduce costs, open the "AI-CRO" "autopilot" 3.0 model.
    specifically, in the CRO pre-preparation, data collection, data verification and wind control, academic discovery four aspects for pharmaceutical companies, CRO enterprises and doctors to provide targeted products to meet specific needs.
    in the early preparation of THE CRO, remote collar has its own Million Data research database and medical writing assistance system can work with experts in depth.
    on the one hand to help the expert committee to set up a special disease queue, on the other hand, the data after desensitivity can also help pharmaceutical companies in the project, patient recruitment, business path and other aspects of intelligent decision-making support.
    the current remote Lymics MOnme platform has worked with dozens of experts to conduct research on cerebrovascular, infectious, kidney, rare diseases and other diseases.
    in data collection, Remote is improving efficiency by optimizing the working habits of people such as CRC (Clinical Coordinator), CRA (Clinical Inspector), PM (Clinical Project Manager), DM (Clinical Data Manager) and others.
    on the one hand, through crowdsourced platform to assign tasks to local pharmaceutical sales staff or research nurses, reduce the enterprise 90% data collection and management of personnel costs, while remote lying independently research and development of Verify data acquisition system can complete the collection of raw data, through the deep learning machine reading understanding EDCNet combined with self-built knowledge map to achieve data automatic input EDC system.
    March 2018, the remotely-picked Verify system officially began to be applied, and the cost of manual entry per case in traditional CRO studies is 1000 yuan, and the remote AI crawl cost is less than 1/10.
    in the field of data verification and wind control, remote collar has developed its own RBM (Risk Based Monitoring, risk-based monitoring) system, is the only domestic clinical research risk designed for large sample size of the overall early warning and control system, which has also become remote medical technology in the foreign enterprise bidding when the "killer", can be data quality, insufficient integration, program violations and other project risk sourcing and early warning.
    in terms of academic discovery, traditional CRO is usually a study of a major target condition, and does not have too strong analytical ability to analyze the abnormal data that occur sourcing in the course of research.
    , but remote collar can guide further research by using data through data through combined with big data anomaly discovery algorithm to find and analyze the cause of data anomalies.
    such as abnormal data may represent a new subgroup, the bidders may be able to find new market positioning of products, increase drug adaptation, may also produce new research topics.
    so far, remote medical technology and more than a dozen well-known listed pharmaceutical companies have reached cooperation.
    integrated CRO trend industry understanding is the key to look at the international market, traditional CRO giants such as Ai Kunwei, Jingding, ICON and so on in the CRO 1.0 information stage started earlier, higher degree of standardization.
    but in the 3.0 stage of AI-CRO, thanks to the development and application of AI technology at home, China's exploration at this stage is not backward than that of foreign countries.
    in the view of Zhang Hongliang, CEO of Remote Medical Technology, the premise of "AI-CRO" is to have the basis to become an excellent CRO enterprise, and then consider the aI technology to empower. "If 'AI-CRO' is a 3.0 era like autonomous driving, then AI technology is the engine to drive the car forward, and the understanding of the CRO industry insight is a high-precision map to ensure that research compliance is conducted legally and efficiently,"
    .
    ", in recent years, more and more players have flocked to the CRO industry to explore a variety of business models to address the pain points of a segment.
    but predictably, integrated CRO is the future trend.
    on the one hand, the implementation of the domestic MAH system to a large extent to promote the improvement of THE concentration of THE CRO industry, only integrated CRO is more competitive with the industry, on the other hand, with China's accession to ICH (human drug registration technology requirements of the International Coordinating Committee), the domestic CRO to follow more stringent international standards and international giants to carry out more brutal competition, integrated enterprises can compete with it.
    this also explains why the domestic large CRO has begun to accelerate the "one-stop" service through merger and acquisition integration and strategic cooperation.
    , for example, the drug-based Mingkang first acquired Pharmapace, who specializes in statistical analysis, and ResearchPoint Global, which specializes in clinical research, and then invested in EngineBiosciences, which has the advantage of AI Big Data, to build a complete CRO service map.
    but from the market competition pattern, and the traditional CRO, big data companies, a single system provider and segment service providers (FSP), remote collar can apply technology to THE CRO chain system, the business by the traditional RCT research , real-world research and data management three parts.
    traditional RCT research proves the experience and professional ability of remote in clinical research, real-world research as the main business has become the core advantage of remote in the market competition, data management business can be for pharmaceutical companies and other CRO enterprises.
    "THE IT TECHNOLOGY IN THE DIGITAL TRANSFORMATION OF THE CRO, THE REAL DIFFICULTY IS THE GRINDING OF THE PRODUCT WHEN THE BUSINESS LANDS AND THE ADJUSTMENT OF WORKFLOW AND HUMAN-MACHINE COLLABORATION SOP."
    " Zhang.
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