VIEWS AND ANALYSIS
CMIC | June 25, 2021
CMIC Co., Ltd., a leading Japanese Contract Research Organization (CRO), and Lokavant, a leading clinical trial intelligence company, announced today that they have agreed to use Lokavant's predictive analytics capabilities to assist CMIC's clinical operations. This strategic collaboration, Lokavant Oversight, monitoring, and operational risk management platform, will be implemented throughout CMIC studies.
CMIC was the first firm in Japan to provide CRO services, and the company has over 28 years of pharmaceutical development expertise in the Asia-Pacific (APAC) area. CMIC Group supports more than 80% of new drug research in Japan. CMIC and Lokavant are some of the first predictive analytics collaborations for clinical trial operations in the rapidly expanding APAC region.
Trial management has gotten more complex and inefficient as the quantity of data points gathered in clinical trials has increased rapidly. The procedure for detecting and managing risks in clinical trials is still largely manual, and it is often too delayed to prevent severe consequences. The collaboration between CMIC and Lokavant goes beyond conventional risk-based monitoring by implementing an end-to-end solution backed by Lokavant's past operational data and CMIC's data. This will enable CMIC to perform next-generation risk-based monitoring, which will be capable of predicting data quality problems, research schedule delays, and budget overruns. CMIC clinical teams will be proactive, rather than reactive, in reducing problems and eventually enhancing trial results by using historical data to predict future issues. Lokavant and CMIC will also collaborate to create data-driven metrics to track study success across previous and current CMIC trials, delivering critical insights to CMIC's 1,200+ clinical trial operators.
Lokavant's data-driven solutions, including its flagship product, Lokavant Oversight, a tech-enabled risk-based monitoring solution, and Lokavant Insight, a clinical operations benchmarking tool, allow next-generation clinical trials. Lokavant Oversight collects and distributes real-time data from various trial data sources, anticipates problems throughout clinical development to reduce trial risks, and empowers monitoring teams by displaying critical research data. Lokavant Insight enables clinical teams to assess clinical trial performance and analyze critical trial success and failure indicators.
About CMIC Group
CMIC Group was established in 1992 as Japan's first Contract Research Organization (CRO). CMIC Group is now Japan's biggest clinical CRO with a worldwide presence, offering complete services in drug development, clinical site management, clinical to commercial GMP manufacturing, regulatory consultancy, and contract sales and marketing solutions. CMIC Group assists pharmaceutical, biotech, and medical device firms in entering the Japanese market, conducting clinical trials in Asia, and bridging drug development and manufacturing requirements in the United States, Europe, Japan, and the rest of Asia. CMIC Group employs approximately 7,000 people and operates from 25 locations across the globe.
AVITA Medical | April 22, 2022
Louis Drapeau has resigned from the Board of Directors of AVITA Medical, Inc. a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, effective April 29, 2022. Mr. Drapeau's resignation is not the result of a disagreement with the Company over any of its operations, policies, or procedures. Rather, he is stepping down for personal reasons.
Since January 2016, Mr. Drapeau has served as Chair of the Audit Committee and as a non-executive Director of AVITA Medical. Louis Drapeau had already stepped down as Chair of the Audit Committee as of February 23, 2022, as disclosed in the Company Form 10-KT dated March 1, 2022. James Corbett was appointed Chair of the Audit Committee in his place as of February 23, 2022, as disclosed in the Company Form 10-KT dated March 1, 2022.
“We want to thank Louis for his time, dedication and contributions to AVITA Medical over the past six years. We appreciate his insights and dedication to the Company and wish him the best.”
Lou Panaccio, Chairman of the Board
eDeviation | April 21, 2021
Ethical GmbH, a Swiss organization that provides personalized software solutions for clinical research committee management, has created a new software solution to help with protocol deviation (PD) evaluation and management.
The new eDeviation® solution will allow clinical trial sponsors, CROs, and EC/IRBs to handle all protocol deviations in a single repository, assess them electronically in a blinded or unblinded manner, and track all operations.
Protocol deviations (PD) are a recognized problem for clinical trials because they can jeopardize subjects' safety, rights, and welfare, as well as the study's data integrity, and thereby violate Good Clinical Practice standards. PDs must be established and submitted to the Institutional Review Board of clinical trials (IRB). They may also be classified as major or minor based on the effect on patient care and data integrity. Finally, corrective measures must be taken to ensure that the PDs do not reoccur, and all decisions and actions must be reported for GxP compliance.
Clinical research teams face a significant administrative burden when it comes to managing and assessing PDs. In this context, a software platform that can support and document both PD assessment and management activities will significantly simplify the work of clinical research teams.
"With eDeviation®, Ethical's portfolio of clinical research software solutions continues to expand to help our customers run their trials more efficiently and effectively," says Mimmo Garibbo, Director of Ethical GmbH. "In an era of increasingly complex clinical trials, we are pleased to have a solution that will assist sponsors, CROs, and EC/IRBs in minimizing the risk associated with protocol deviations."
About Protocol Deviations
A protocol deviation is any change, divergence, or departure from the approved protocol, consent agreement, recruitment process, or study materials (e.g., questionnaires) originally approved by the EC/IRB. The expression "protocol deviation" refers to protocol exceptions, modifications made to avoid immediate damage to subjects, and protocol violations. Protocol deviations may be classified as major or minor based on their effect on patient safety and data integrity.
eDeviation® is a Protocol Deviations and Violations management cloud software designed to collect, manage and review protocol deviations in a simple, effective, and GxP-compliant way.