Medidata | April 01, 2022
A Dassault Systèmes company, Medidata, announced that Labcorp, a leading global life sciences company, has extended its 14-year partnership with Medidata, laying the groundwork for their initiative to co-develop digital biomarkers and expand the use and functionality of decentralized clinical trials.
“Our relationship with Medidata is built on using their core technologies to enhance our clinical trial portfolio and continue to expand our decentralized clinical trial offerings. Our work to advance sensor and digital biomarker usage in clinical research can help accelerate patient care while providing valuable information to study sponsors.”
Bill Hanlon, Ph.D., chief scientific officer and president of Clinical Therapeutic and Regulatory Sciences, Labcorp Drug Development
Labcorp Drug Development's products are based on Medidata technology, including Rave EDC, Coder, and TSDV. In addition, Labcorp is currently using most of the Medidata Clinical Cloud platform, including eCOA, RTSM, and Imaging.
“The last two years have required clinical trials to become more accessible and flexible; these changes make our strategic partnership with Labcorp Drug Development to modernize and decentralize trials even more critical,” said Anthony Costello, CEO Patient Cloud at Medidata. “With this new agreement, we’re excited to develop and deploy the innovations that help our customers run more effective clinical programs and get new treatments to patients faster than ever before.”
Through its 3DEXPERIENCE platform, Medidata is positioned to lead the digital transformation of life sciences in the era of personalized medicine by providing the industry's first end-to-end scientific and business platform, from research to commercialization.
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.
Narrativa | May 19, 2021
Narrativa, which has developed an artificial intelligence (AI) medical writing platform to assist pharmaceutical firms in speeding up drug approval and lowering overall compliance costs, recently completed a $1.3 million funding round.
The Los Angeles-based firm currently uses its SaaS platform to automate the production of Clinical Study Reports (CSRs) and other regulatory reports for several pharmaceutical firms and other clinical research organizations (CROs).
The AI-writing assistant platform utilizes advanced Natural Language Generation (NLG) to process millions of data points from clinical trials and generate readable and understandable written medical narratives, improving accuracy and minimizing the time and expense of producing critical (and time-consuming) regulatory documents.
"The pharma industry has evolved as a result of the availability and quality of data from clinical trials, with the most significant impact on drug discovery. To detect trends, test hypotheses, and understand the effectiveness of treatments, pharmaceutical firms have often focused on empirical data. It's time to put artificial intelligence to work assisting medical authors in the development of regulatory documents "Narrativa's founder and CEO, David Llorente, says.
Pharmaceutical firms spend more than $1.5 billion on regulatory documentation, and it may take up to a year to complete the paperwork for FDA approval of a new drug. The amount of time taken on regulatory documentation significantly lengthens the time it takes for new drugs to reach the market.
Narrativa was established in 2015 with the idea that technology should be used to positively transform the world. Narrativa, named one of the most important companies in the field of NLG by Samsung, helps companies expand by anticipating trends and converting data into the human language in real-time. Narrativa creates automated content in a variety of areas, including finance, pharmaceuticals, insurance, media, and gaming, using its artificial intelligence system and machine learning experience.