CDISC

Clymb Clinical, LLC Unveils TFL Designer: An Innovative Community Solution for Clinical Data Analysis and Reporting

Retrieved on: 
Thursday, February 15, 2024
Medicine, Medical device, Entrepreneurship, CDISC, TFL, Software engineering, Table, Metadata, Community, Software

BEDFORD, Mass., Feb. 15, 2024 /PRNewswire/ -- Clymb Clinical, LLC announced the launch of their community solution, TFL Designer.

Key Points: 
  • BEDFORD, Mass., Feb. 15, 2024 /PRNewswire/ -- Clymb Clinical, LLC announced the launch of their community solution, TFL Designer.
  • TFL Designer has transformed the landscape of clinical data reporting by offering a comprehensive solution for designing and generating Tables, Figures, and Listings (TFLs), essential components of every clinical study report.
  • "The Community launch today represents a huge milestone for our company and for the larger clinical data science community," said Co-Founder, Colin Izzo.
  • TFL Designer is the first-of-its-kind solution which bridges the gap that currently exists in the statistical analysis and reporting space.

Linden Capital Partners and Ontario Teachers’ Pension Plan Launch Initiative Focused on Clinical Research Advancement

Retrieved on: 
Thursday, February 8, 2024
Health, Practice Management, Other Health, General Health, Research, Science, Biotechnology, CDISC, Head, PRA Health Sciences, Chairperson, IQVIA, Patient, PPD, Pharmaceutical industry

Linden Capital Partners (Linden) and Ontario Teachers’ Pension Plan (Ontario Teachers’) are pleased to announce they are partnering on a transformative platform, led by Dr. John Potthoff , with the goal of revolutionizing the clinical research ecosystem.

Key Points: 
  • Linden Capital Partners (Linden) and Ontario Teachers’ Pension Plan (Ontario Teachers’) are pleased to announce they are partnering on a transformative platform, led by Dr. John Potthoff , with the goal of revolutionizing the clinical research ecosystem.
  • This strategic initiative is centered around investing in exceptional companies and deploying cutting-edge technology to foster seamless connections and collaborations among patients, research sites, pharmaceutical companies, and the broader clinical research community.
  • The platform will be led by Dr. John Potthoff, who is currently the Chairperson of Elligo Health Research ®.
  • Our commitment is to address these challenges head-on and catalyze positive change in our industry.”
    Vision for a Unified Clinical Research Ecosystem: The initiative is dedicated to building a more unified and efficient clinical research ecosystem.

Lindus Health Introduces Bespoke "All-In-One CRO for Digital Therapeutics" Solution to Companies in the Space Streamline Clinical Trials

Retrieved on: 
Thursday, February 1, 2024
Partnership, Pi, Acacia, DTA, Health information management, Data management, Clinical data management, ChromeOS, Clinical trial, Therapy, Tinnitus, Patient, De novo, Digital, Social anxiety, FDA, Single-frequency network, Multi-function printer, EDC, Data collection, Diabetes, Electronic health record, CDISC, Software, CTMS, Lindus, App Store (iOS/iPadOS), Near-sightedness, Fine chemical

Lindus Health's new offering for the DTx market bundles the services of an experienced CRO in DTx.

Key Points: 
  • Lindus Health's new offering for the DTx market bundles the services of an experienced CRO in DTx.
  • This offering is intended to produce a true "one-stop-shop" experience for everything needed to run a DTx clinical trial.
  • Technology-driven recruitment services: Lindus Health employs a variety of different strategies to accelerate DTx trials.
  • Lindus Health's "All-In-One CRO" offering enables DTx companies to achieve study milestones faster through their tech-forward and patient-centric approach to executing clinical trials.

Patient Safety Set to Gain as CDISC and UMC Partner to Improve Interoperability of CDISC Standards and WHODrug Global

Retrieved on: 
Monday, January 22, 2024
Data Management, Biotechnology, Technology, Professional Services, Health, General Health, Pharmaceutical, Health Technology, Research, Data Analytics, Science, Multimedia, Partnership, Pharmacovigilance, CDISC, WHO, Safety, UMC, Organization, Patient safety, Vaccine, Uppsala Monitoring Centre, Pharmaceutical industry

View the full release here: https://www.businesswire.com/news/home/20240122291747/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240122291747/en/
    Historically, lack of interoperability has been a significant stumbling block to the effective sharing and use of medicinal product safety data.
  • Together, CDISC and UMC will work to strengthen interoperability between CDISC standards and WHODrug Global for the benefit of users, regulatory bodies, and the broader healthcare community.
  • “CDISC is excited to expand our long collaboration with Uppsala Monitoring Centre to support the global community in connecting WHODrug Global with CDISC’s Study Data Tabulation Model,” said Chris Decker, President and CEO, CDISC.
  • CDISC and UMC will also promote and encourage participation in each other's user group events, conferences, and workshops.

EDETEK Launches CONFORM™ Statistical Computing Environment (SCE)

Retrieved on: 
Wednesday, December 6, 2023
SCE, Senior, TLF, Language, Informatics, Statistics, CDISC, Movement, Product strategy, Metadata, Trial of the century, Freedom, SDLC, GXP, Systems development life cycle, Data, Environment, Drug development, Video game

PRINCETON, N.J., Dec. 6, 2023 /PRNewswire/ -- EDETEK Inc., a leading global provider of modern clinical technology solutions and services for the biopharmaceutical, medical devices and CRO companies, announced today a new innovative product in the CONFORM™ Informatics Platform - Statistical Computing Environment.

Key Points: 
  • CONFORM™ Statistical Computing Environment (SCE) was built to solve many challenges faced by clinical programmers and statisticians.
  • "CONFORM™ SCE enables clinical programmers to maximize the power of the CONFORM™ Informatics Platform.
  • SCE accelerates clinical study reporting, submission, analysis and statistical modeling while having access to fully integrated CONFORM™ modules for real time data ingestion from 70+ popular clinical and medical systems.
  • The platform not only provides regulatory compliance functions and controls, but also manages tasks through an intuitive integrated development environment, enhancing the efficiency of clinical programmers' daily tasks.

CDISC and DiMe Partner to Advance DHT Data Standards to Improve Health Outcomes

Retrieved on: 
Tuesday, October 10, 2023
Other Philanthropy, Data Management, Other Science, FDA, Technology, Research, Other Health, Radiology, Pharmaceutical, Oncology, Medical Devices, Infectious Diseases, Health Technology, Clinical Trials, Philanthropy, Biotechnology, Software, Health, Foundation, Science, Partnership, Multimedia, Doctor of Philosophy, Pastry (DHT), Data, Organization, CDISC, Clinical Data Interchange Standards Consortium, Radiation, Semantics, Digital health, Device, Medical imaging, Dime

Clinical Data Interchange Standards Consortium ( CDISC ) and Digital Medicine Society ( DiMe ) are proud to announce a groundbreaking partnership aimed at enhancing the standardization of digital health technologies (DHTs) data.

Key Points: 
  • Clinical Data Interchange Standards Consortium ( CDISC ) and Digital Medicine Society ( DiMe ) are proud to announce a groundbreaking partnership aimed at enhancing the standardization of digital health technologies (DHTs) data.
  • Further integration of data from DHTs into clinical research supports the development of preventive approaches, harm reduction strategies, and quality therapies to improve health outcomes.
  • “Our partnership with CDISC is a critical step in unlocking the potential of digital health technology data standards to improve the quality and efficiency of digitally-enabled clinical research,” Jessie Bakker, PhD, Vice President of Digital Measures and Diagnostics at DiMe.
  • Stakeholders across the digital health and healthcare ecosystem can expect numerous benefits from this collaboration, including enhanced data interoperability and comparability of data across different digital health technologies and applications and accelerated innovation in digital health through shared standards and common semantics.

Beaconcure Technologies Welcomes Additions to Leadership Team

Retrieved on: 
Tuesday, October 3, 2023
Technology, Biotechnology, FDA, Health, Pharmaceutical, Artificial Intelligence, Other Science, Research, Software, Networks, Health Technology, Science, Data Management, Clinical Trials, GSK plc, Software as a service, Partnership, Central Waqf Council, Senior, Marketing, LLM, Bill & Melinda Gates Foundation, Clinical trial, Information science, MBA, CMO, History, Doctor of Philosophy, AstraZeneca, Organization, Friends, Neuroscience, Dermatology, Biometrics, COVID-19, MD, Patient, Celebrity board director, Commercial, Friends of Cancer Research, Rare, CDISC, Cardiology, Biostatistics, Enterprise data planning, Automation, Data science, Management, Pharmaceutical industry

Beaconcure Technologies , a leader in AI-enabled clinical data validation and automation, announces enhancements to its leadership team, emphasizing its dedication to innovation in drug delivery and clinical data science.

Key Points: 
  • Beaconcure Technologies , a leader in AI-enabled clinical data validation and automation, announces enhancements to its leadership team, emphasizing its dedication to innovation in drug delivery and clinical data science.
  • Beaconcure is pleased to introduce the following professionals who have joined their Strategic Advisory Board and Commercial Leadership teams:
    Dr. Karen Smith , MD, PhD, MBA, LLM: Dr. Smith, a distinguished biotech and pharmaceutical executive, has joined Beaconcure's Strategic Advisory Board.
  • Beaconcure CEO and co-founder Yoran Bar comments on the significance of these appointments, highlighting their dedication to healthcare innovation.
  • Yoran Bar remarked, "Welcoming Dr. Karen Smith, Névine Zariffa, and Sean Wall to our vibrant team marks a monumental milestone for Beaconcure Technologies.

eClinical Solutions to Discuss Industry Need for Clinical Data Lakehouse and AI-Enabled Data Management at DPHARM, SCDM, PHUSE EU, Among Other Upcoming Conferences

Retrieved on: 
Tuesday, September 19, 2023
Technology, Clinical Trials, Health Technology, Professional Services, Software, Networks, Health, Data Analytics, Data Management, Cloud, Data management, Medicine, Society, Clinical data management, Primary energy, Comes, Automation, Good clinical data management practice, Organization, Future, Digital Future Coalition, Outline, Architecture, AI, Digital, CDISC, Conference, Risk management, Pharmaceutical industry, Medical device

eClinical Solutions will also host several product demonstrations at these events to showcase how the elluminate® Clinical Data Cloud and eClinical biometrics services provide accurate and timely data insights for better decision-making to support tomorrow’s breakthroughs.

Key Points: 
  • eClinical Solutions will also host several product demonstrations at these events to showcase how the elluminate® Clinical Data Cloud and eClinical biometrics services provide accurate and timely data insights for better decision-making to support tomorrow’s breakthroughs.
  • The company will also head to the 2023 Clinical Data Interchange Standards Consortium (CDISC) US Interchange (October 18-19) in Washington, DC.
  • The latter presentation from Diane Lacroix, VP of clinical data management, will explore how the human in the loop informs, adopts and utilizes AI applications for clinical data management.
  • For more information on these events, as well as others eClinical will be attending this fall, visit: https://www.eclinicalsol.com/events .

Certara collaborates with Korea Institute of Toxicology to ensure FDA submission-ready SEND dataset

Retrieved on: 
Friday, August 4, 2023
Science, Software, Biotechnology, Research, Pharmaceutical, Health, Technology, Clinical Trials, Clinical Data Interchange Standards Consortium, Medicines and Healthcare products Regulatory Agency, Adam, Korea Institute of Science and Technology, SDTM, Toxicity, KIT, Data analysis, PMDA, Drug discovery, Toxicology, CORA dataset, SEND, R, CDISC, FDA, NMPA, Exploration, Medical device, Online shopping, Certara

Certara, Inc. (Nasdaq: CERT), a global leader in Biosimulation, today announced that a Korea Institute of Toxicology (KIT) have decided to implement Certara’s Pinnacle 21 Enterprise data conformance and submission software and SEND Explorer pre-clinical data visualization software .

Key Points: 
  • Certara, Inc. (Nasdaq: CERT), a global leader in Biosimulation, today announced that a Korea Institute of Toxicology (KIT) have decided to implement Certara’s Pinnacle 21 Enterprise data conformance and submission software and SEND Explorer pre-clinical data visualization software .
  • The combination of Pinnacle 21 Enterprise and SEND Explorer enables synergy for meeting global regulatory guidelines and delivering efficiency.
  • SEND Explorer is a validated, web-based application that provides advanced viewing, data summarization and visualization capabilities for nonclinical study data.
  • Using SEND Explorer, scientists generate visualizations of single and multiple toxicology studies to inform decisions and quickly address questions from health authorities.

Algorics Strengthens Board of Directors and Leadership with New Appointments

Retrieved on: 
Thursday, August 3, 2023
GSK, Business development, Senior, RPS, Clinical trial, ICON, AstraZeneca, Algorism, MDS, SAS, Organization, Data science, Syneos Health, Schonfeld Strategic Advisors, Pleasure, Growth, FDA, ChromeOS, Automation, Quantic Dream, Management, Fine chemical, Parexel, CDISC

On his appointment, Mr. Morgan commented "It's been a pleasure to watch Algorics grow over the years to become one of the leading clinical data science organizations.

Key Points: 
  • On his appointment, Mr. Morgan commented "It's been a pleasure to watch Algorics grow over the years to become one of the leading clinical data science organizations.
  • Over the last 30 years, he has held various leadership positions within CROs, having started his career with AstraZeneca and GSK.
  • His career highlights include leadership positions at ICON, Covance, Excelya, Quanticate, MDS (now Syneos Health), RPS (now PRA/ICON), and Gentronix.
  • He has held various roles, ranging from lead technical positions to leadership roles, and spearheaded automation initiatives in various pharmaceutical companies.