SDTM | Jotup

Bioforum Expands Leadership Team with Appointment of Michael Goedde as President

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Tuesday, March 19, 2024

NESS ZIONA, Israel, March 19, 2024 /PRNewswire/ -- Bioforum, the Data Masters, a leading contract research organization (CRO) focused on the delivery of biometric services and solutions to the global clinical trials industry, today announced the appointment of Michael Goedde as its President. A clinical data management expert whose career in the life sciences industry spans over three decades, Goedde will drive the development and execution of Bioforum's global growth and innovation strategy.

Key Points:

A clinical data management expert whose career in the life sciences industry spans over three decades, Goedde will drive the development and execution of Bioforum's global growth and innovation strategy.
"As we expand our presence in North America and around the world, I'm delighted to welcome Michael to the Bioforum family and confident that his leadership will be invaluable in driving our long-term growth and success."
Prior to ICON, Goedde spent four years at Parexel in roles of increasing responsibility, most recently as Vice President of Global Data Operations.
He holds a bachelor's degree in computer science from Computer Lern Zentrum (CLZ) Hoechst AG in Frankfurt, Germany.

Bioforum Signs Exclusive Deal to Acquire Assets from Abond CRO Inc., Expanding Reach of Global Biometric Services

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Tuesday, February 20, 2024

Doctor of Philosophy, BioGRID, Research, FDA, Data management, NESS, Entrepreneurship, Organization, SDTM, Automation, Patient, Biostatistics, Clinical trial, Hand

NESS ZIONA, Israel, Feb. 20, 2024 /PRNewswire/ -- Bioforum, the Data Masters, a leading contract research organization (CRO) focused on the delivery of biometric services and solutions to clinical trial sponsors worldwide, today announced that it has been exclusively selected by Abond CRO Inc., a full-service CRO that ceased operations in December 2023, to provide business continuity services to its biopharmaceutical and medical device customers around the globe. Under the terms of the agreement, Abond customers will have the opportunity to seamlessly transition to Bioforum and receive best-in-class data management and statistical analysis services to drive clinical trial efficiency.

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Under the terms of the agreement, Abond customers will have the opportunity to seamlessly transition to Bioforum and receive best-in-class data management and statistical analysis services to drive clinical trial efficiency.
Several US-based biotechs and long-term Abond clients recently signed agreements with Bioforum.
Additionally, several former Abond executives have joined Bioforum, including subject-matter experts in statistical consulting and adaptive clinical trial design.
"Like Abond, Bioforum is passionate about accelerating clinical trials and providing a better experience for research stakeholders by optimizing critical processes and eliminating pain points that create burdensome inefficiencies," said Amir Malka, Bioforum's CEO and Co-Founder.

Bioforum Expands Clinical Trial Technology and Services with Acquisition of Validify

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Monday, November 20, 2023

NESS, Data management, Acquisition, Organization, BioGRID, Clinical trial, CSA, Patient, CSV, Documentation, Automation, Computer, Software, Software as a service, Medical imaging, Medical device, SDTM

NESS ZIONA, Israel, Nov. 20, 2023 /PRNewswire/ -- Bioforum, a data-focused, technology-driven CRO, today announced the acquisition of Validify (Applato Systems Ltd.), a leader in the automation of computer systems validation (CSV). With this expansion, Bioforum is addressing the growing demand for proven technology solutions to digitize and automate CSV, a traditionally manual, paper-based, process that can be prone to errors and compliance risks and costly and time-consuming for life sciences organizations to implement.

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Acquisition Adds Computer Systems Validation Automation Capabilities, Further Enriching Bioforum's End-to-End Suite of Solutions for Clinical Trial Data Management
NESS ZIONA, Israel, Nov. 20, 2023 /PRNewswire/ -- Bioforum , a data-focused, technology-driven CRO, today announced the acquisition of Validify (Applato Systems Ltd.), a leader in the automation of computer systems validation (CSV).
Validify provides a proven, agile, cloud-based platform that is fully configurable and rapidly deployable, enabling clinical trial sponsors to digitize their validation process, implement a risk-based computer software assurance (CSA) approach, and eliminate the burdens of the traditional CSV process with a comprehensive automation solution.
Malka added: "Our acquisition of Validify represents a natural next step and an exciting growth opportunity for Bioforum, and we're proud to welcome a team that shares our commitment to delivering solutions that move clinical trials forward and accelerate the delivery of new treatments to patients."
Ido Raz, CEO and co-founder of Validify, and the architect of its platform, will join Bioforum and continue to lead the development and commercialization of the SaaS solution:

ThoughtSphere Celebrates 5 Years of Delivering AI enabled Efficiencies in Clinical Trial Operations

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Thursday, October 5, 2023

Patent, Acquisition, Independent medical review, Site, Risk, Data management, Database, Clinical trial, SAN, Central Monitoring System, SDTM, United States patent law, Medical device, Sales

SAN JOSE, Calif., Oct. 5, 2023 /PRNewswire/ -- ThoughtSphere, an industry leader of clinical data and analytics solutions, celebrates 5 years of delivering customers AI/ML capabilities to increase the speed and quality of clinical trial operations.

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SAN JOSE, Calif., Oct. 5, 2023 /PRNewswire/ -- ThoughtSphere, an industry leader of clinical data and analytics solutions, celebrates 5 years of delivering customers AI/ML capabilities to increase the speed and quality of clinical trial operations.
In 2019, ThoughtSphere received a US Patent for ClinHUB, its data ingestion and harmonization engine that uses study metadata and clinical data to automate the process of data mapping to a target model such as SDTM.
"The cornerstone to make the vision a reality was unifying data in an efficient and scalable way using AI.
To learn more about ThoughtSphere and the platform's full suite of solutions, please visit thoughtsphere.com.

ThoughtSphere Celebrates 5 Years of Delivering AI enabled Efficiencies in Clinical Trial Operations

Retrieved on:

Thursday, October 5, 2023

Patent, Acquisition, Independent medical review, Site, Risk, Data management, Database, Clinical trial, SAN, Central Monitoring System, SDTM, United States patent law, Medical device, Sales

SAN JOSE, Calif., Oct. 5, 2023 /PRNewswire/ -- ThoughtSphere, an industry leader of clinical data and analytics solutions, celebrates 5 years of delivering customers AI/ML capabilities to increase the speed and quality of clinical trial operations.

Key Points:

SAN JOSE, Calif., Oct. 5, 2023 /PRNewswire/ -- ThoughtSphere, an industry leader of clinical data and analytics solutions, celebrates 5 years of delivering customers AI/ML capabilities to increase the speed and quality of clinical trial operations.
In 2019, ThoughtSphere received a US Patent for ClinHUB, its data ingestion and harmonization engine that uses study metadata and clinical data to automate the process of data mapping to a target model such as SDTM.
"The cornerstone to make the vision a reality was unifying data in an efficient and scalable way using AI.
To learn more about ThoughtSphere and the platform's full suite of solutions, please visit thoughtsphere.com.

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

Retrieved on:

Friday, August 4, 2023

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 .

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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.

Saama Launches Industry’s First AI-driven Data Platform to Accelerate Clinical Development

Retrieved on:

Tuesday, June 20, 2023

Saama , a provider of AI- and ML-based solutions that accelerate clinical development and commercialization, announced today the launch of its unified platform of SaaS-based products to accompany its existing portfolio of customized solutions and services.

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Saama , a provider of AI- and ML-based solutions that accelerate clinical development and commercialization, announced today the launch of its unified platform of SaaS-based products to accompany its existing portfolio of customized solutions and services.
The new Saama platform deploys its proven artificial intelligence (AI)- and machine learning (ML)-enhanced solutions to automate key clinical development processes and provide a holistic view of trial operations and patient progress in one location.
“By unifying our product suite into the Saama platform, we have the foundation to support clinical trials in a repeatable and scalable way.
Smart Data Quality (SDQ) – automates data cleaning, review, and reconciliation processes for data managers, reducing query generation times by as much as 90% per query.

Algorics announces a new release for MetaVate with revolutionary clinical data transformation automation features

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Tuesday, May 23, 2023

Metadata, Metaves, Adam, SDTM, Algorism, Organization, Acquisition, Algorithm, CDISC, Automation, Data science, Medical device

With revolutionary data transformation and AI-enabled automation capabilities, MetaVate changes the data transformation process in clinical research.

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With revolutionary data transformation and AI-enabled automation capabilities, MetaVate changes the data transformation process in clinical research.
Designed to help sponsors automate the data standardization process, MetaVate comes with an inbuilt CDISC-compliant metadata library framework to support clinical data transformation from any source to any target, including legacy, CDASH, SDTM, ADaM, and Non-CRF data.
3rd-party data handling: Metadata agnostic design allows MetaVate to establish data and metadata integrity checks over Non-CRF data to facilitate oversight on third-party data acquisition and integration into existing clinical data lakes.
Every new release of MetaVate is a testament to Algorics' commitment to delivering innovative solutions that meet the evolving needs of businesses.

How To Accelerate & Improve the Quality of CDISC SDTM Deliverables: Design with the End in Mind, Upcoming Webinar Hosted by Xtalks

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Thursday, November 17, 2022

Quality, Clinical data acquisition, Clinical Data Interchange Standards Consortium, Data collection, Safety, FDA, Global Partnership on Artificial Intelligence, SDTM, Acceleration, NCI, Risk, Food, CDISC, Medical device, Pharmaceutical industry, Risk management

TORONTO, Nov. 17, 2022 /PRNewswire-PRWeb/ -- Since the FDA passed regulations requiring submitted datasets to be compliant with the CDISC Study Data Tabulation Model (SDTM), clinical trial sponsors have faced a dilemma. Should they design electronic case report forms (eCRFs) in line with SDTM from the outset? Or should they retrospectively convert data to CDISC SDTM at the end?

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The featured speakers will discuss the benefits of aligning with the Clinical Data Interchange Standards Consortium (CDISC) from study design.
The speakers will discuss how technology enables earlier Study Data Tabulation Model (SDTM) conversions and faster access to data.
Will it be possible to retrofit datasets and terminology into the CDISC SDTM and NCI Controlled Terminology models?
For more information, or to register for this event, visit How To Accelerate & Improve the Quality of CDISC SDTM Deliverables: Design with the End in Mind .

PointCross Releases eDataValidator for SDTM, ADaM, SEND, and Define.XML Conformance to Prevailing FDA, CDISC, and PMDA Rules

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Wednesday, July 20, 2022

GLOBE, BLA, API, XPT, Solution, Cros, PMDA, NDA, Data, Risk, SOP, CSV, Sponsor, SEND, Organization, San Francisco Bay Area, Adam, Review, FDA, Big data, Regulation, Industry, SDTM, CDISC, List of life sciences, Fine chemical, Stroke volume, Microsoft Excel, IND

FOSTER CITY, Calif., July 20, 2022 (GLOBE NEWSWIRE) -- PointCross Life Sciences announced today the full complement release of its eDataValidator (eDV) for validating SDTM,ADaM,SEND and Define.XML data for conformance to prevailing FDA, CDISC, and PMDA rules.

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FOSTER CITY, Calif., July 20, 2022 (GLOBE NEWSWIRE) -- PointCross Life Sciences announced today the full complement release of its eDataValidator (eDV) for validating SDTM,ADaM,SEND and Define.XML data for conformance to prevailing FDA, CDISC, and PMDA rules.
eDV offers limitless validation of Clinical SDTM as well as Nonclinical SEND, making this a single solution for IND, NDA and BLA preparation.
This is an ideal option for quick, inexpensive on/off ramp use by organizations working on specific trial or study data.
On-Premise installations of eDataValidator for organizations committed to having an integrated, qualified, validated workflow subject to their SOPs.