Recently, Medlive announced the launch of its one-stop CRO services for Phase I–IV clinical trials, providing pharmaceutical and medical device companies as well as physicians with full lifecycle support ranging from clinical research medical strategy to the delivery of clinical outcomes.
Medlive’s Clinical CRO Services leverage the professional expertise and management experience of Japan’s leading CRO company under the M3 Group, combined with Medlive Group’s over two decades of practical experience in empowering more than 3 million physicians to make better clinical decisions through digital solutions. Our service scope covers project management, clinical monitoring, medical writing, data management, statistical analysis, and quality management. Furthermore, by leveraging Medlive Group’s IT technological advantages, we provide next-generation clinical trial services, such as remote intelligent clinical trials tailored to meet local needs in China.
According to Frost & Sullivan, outsourcing clinical trials to CROs can save approximately 25% of R&D time compared to pharmaceutical companies conducting trials in-house, significantly improving the efficiency of new drug development. This is equivalent to extending the patent protection period after a new drug’s market launch, thereby increasing the company’s potential revenue.
Driven by factors such as continuously increasing R&D investment and policy support for innovative development in the pharmaceutical industry, China’s CRO industry has ushered in a period of growth. According to Frost & Sullivan data, the size of China’s clinical-stage CRO market is projected to grow from $4.4 billion in 2020 to $13.7 billion in 2024, with an expected compound annual growth rate (CAGR) of 32.84% from 2020 to 2024. As drug development costs rise rapidly and research cycles lengthen, the value of the CRO industry has become increasingly apparent. It has rapidly evolved into an indispensable link in the drug development value chain. In recent years, collaboration between pharmaceutical companies and CRO firms has strengthened, leading to a continuous increase in the proportion of CRO spending within total drug development expenditures.
The core team of Medlive has over 15 years of practical experience in clinical research. Leveraging M3 Group’s advantages in the CRO sector, Medlive will further expand its clinical research service capabilities to provide high-quality, digital, and full-function clinical research services, thereby empowering the development of clinical research in China.
The COVID-19 pandemic, which began in late 2019, has transformed the conduct of clinical trials. Travel restrictions and researchers’ desire to minimize face-to-face interactions have created new demands for remote engagement and digital transformation across all stages of clinical trials. Leveraging over two decades of accumulated expertise in digitally empowering healthcare, Medlive will effectively support its clinical CRO services. Medlive’s clinical CRO services hold core advantages in physician outreach capabilities, patient management platforms, digitalization, and high-quality standards.
As of June 2021, the total number of registered physicians on the Medlive platform grew to 2.5 million, accounting for 60% of physicians in China. In October 2021, Medlive acquired a 60% stake in Medikang, China’s leading SaaS solution provider for medical conferences, enabling more effective integration of physician resources. Leveraging 26 years of accumulation, Medlive has begun to combine insights into physicians’ cognition, preferences, academic and clinical learning needs, along with long-cultivated physician stickiness, to deliver clinical trial information and requirements to investigators and relevant physicians in a high-quality and precise manner. Through its unique physician platform, Medlive enhances collaboration efficiency between clinical trial project teams and physicians, thereby facilitating more efficient execution of feasibility studies, site selection, patient recruitment, investigator training and management, investigator meetings and communications, and publication of trial results.
Medlive leverages “Internet + intelligence” to expand from physician education to an integrated doctor-patient management model, providing patients with a one-stop, whole-disease-course service that includes patient community interaction, online diagnosis and treatment, follow-up management, and patient education. It will support various aspects of clinical trials, including subject recruitment, electronic informed consent, clinical trial education, compliance management, remote follow-up, ePRO, and remote drug administration.
Medlive CRO’s Electronic Data Capture (EDC) system for clinical trials adopts a multi-center, internet-based model. The system fully complies with CDISC standards, designs Case Report Forms (CRFs) in accordance with CDASH guidelines, supports ODM V1.3 standards for data storage and transmission, and ensures that data content conforms to SDTM standards. It meets the dual requirements of single-center research activities and multi-center clinical studies, satisfying regulatory requirements for clinical trial data submission. Furthermore, leveraging the advantages of integrated doctor-patient management, it establishes a technical platform for Decentralized Clinical Trials (DCT), thereby enhancing patient experience and improving clinical trial efficiency.
In 2013, Medlive introduced strategic investment from M3, Japan’s largest physician community. M3 operates Japan’s largest physician community, covering nearly 90% of physicians in the country. M3’s extensive experience in physician platform operations, its digital marketing model, and its strong consulting and planning capabilities have significantly contributed to the development of Medlive’s core business model, “Precision Education and Enterprise Solutions.”
With M3’s support, Medlive began developing digital education solutions capable of evaluating return on investment (ROI) eight years ago and has gradually established a comprehensive personnel structure to deliver end-to-end solutions. These solutions encompass medical strategy analysis, digital content design, physician behavior profiling, precision diagnosis and treatment cognitive education, and assessment of clinical practice standards. Leveraging its more than two decades of clinical research experience in the Asia-Pacific region, along with its systematic platforms, quality management systems, and project expertise, M3 empowers Medlive’s development in clinical research.
As new drug development becomes increasingly complex and challenging, while demand for novel therapies continues to rise, the CRO industry has sustained robust growth. Medlive’s launch of a one-stop clinical CRO service represents another strategic initiative in its ongoing efforts to strengthen its position across the industry value chain.