Clinical Data Interchange Standards Consortium (CDISC)
See the following -
Academic Sector Leverages Open-Source Concept in Development
Biopharma companies are pursuing open-innovation collaborations with an eye on speeding up research and discovery work. Academic and independent research institutions are also teaming up with industry to discover new treatments under this open-source model. Read More »
- Login to post comments
CDISC and TransCelerate Announce New Standard for Breast Cancer to Support Data Sharing for Oncology Research
The need to rapidly and efficiently share new data in cancer research was recently, and powerfully, highlighted by U.S. Vice President Joe Biden as part of the Cancer Moonshot initiative. The Clinical Data Interchange Standards Consortium (CDISC) and TransCelerate BioPharma, Inc. (“TransCelerate”) announce today the open availability of a new CDISC Therapeutic Area (TA) Standard for Breast Cancer. The CDISC global TA standards can streamline the way clinical research is conducted so that data can be readily shared among clinicians, researchers and regulators around the world, thus leading to more rapid and “smarter” research...
- Login to post comments
CDISC Announces Launch Of CDISC eSHARE
The Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce the official launch of CDISC eSHARE. For the first time, CDISC metadata standards in multiple formats are now electronically accessible by computer applications through an integrated system...
- Login to post comments
Clinovo Launches New Version Of CDISC® Express, Its CDISC SDTM Mapping Tool
Downloaded Over 900 Times Globally, Clinovo Releases CDISC Express version 1.1, its SAS-based CDISC SDTM Conversion Tool, adding additional domains and following the new SDTM 3.1.3 specifications. Read More »
- Login to post comments
How Cloud-Based Tools Can Help With FDA Compliance
These days, enforcing FDA compliance and mentoring new team members are more challenging than ever, thanks to a workforce that is more remote, international, and diverse. [...] With these changes, pharmaceutical companies need to adapt to grow and ride the cost-conscious trend just to survive... Read More »
- Login to post comments
Open Source Software Creeps into Healthcare through Clinical Research
Although open source has not conquered the lucrative market for electronic health records (EHRs) used by hospital systems and increasingly by doctors, it is making strides in many other important areas of health care. One example is clinical research, as evidenced by OpenClinica in field of Electronic Data Capture (EDC) and LabKey for data integration. Last week I attended a conference for people who use OpenClinica in their research or want to make their software work with it. At any one time, hundreds of thousands of clinical trials are going on around the world, many listed on an FDA site. Many are low-budget and would be reduced to using Excel spreadsheets to store data if they didn’t have the Community edition of OpenClinica. Read More »
Overview of Major eClinical Trends and Clinical Research
Clinical research is well on its way to transforming its paper-driven model to an all things electronic format. During the past year, the clinical trial industry has made considerable progress in adopting technology as a way to streamline data collection, transmission, and monitoring. This article focuses on the top eClinical trends of 2015 and beyond. Among the latest developments- adoption rates are higher for electronic data capture (EDC), electronic source data (eSource), and eClinical integration, as the focus is now on capturing real-time data as a continuous stream. These trends are partially the result of high-tech devices, sensors and wearables entering the clinical trial industry, as well as the FDA embracing technology and opening up a dialogue with experts on how to best channel this revolution in order to advance clinical research.
- Login to post comments
Pharmaceutical And IT Communities Collaborate On OASIS Clinical Trial Data Standard For Content Management Systems
The pharmaceutical community, health care organizations, and software providers are coming together at the OASIS open standards consortium to define a machine-readable content classification standard for the interoperable exchange of clinical trial data via content management systems. The work of the new OASIS Electronic Trial Master File (eTMF) Standard Technical Committee will promote interoperability across diverse computing platforms and cloud networks within the clinical trials community.
- Login to post comments
Roche, Medivation, Santen and Biomarin Will Discuss CDISC Implementation Challenges At The Next Silicon Valley BioTalks
Panel composed of CDISC experts from Roche, Medivation, Santen, Biomarin and Clinovo will discuss and share ideas around the topic: “CDISC for Medical Device Companies: Progress Made and Best Practices from Pharma/Biotech Implementation”. Read More »
- Login to post comments
Why Open Source Is the Future of Clinical Trials
Clinovo is a Clinical Research Organization (CRO) that partners with life science companies to streamline their clinical trials. Their CTO Marc Desgrousilliers is managing the development of ClinCapture, their open source Electronic Data Capture (EDC) system. In this interview, he tells us more about why healthcare needs open source and why it is the future of clinical trials... Read More »
- Login to post comments
Learning Health System-Essential Standards To Enable Learning (ESTEL)
CDISC and the leadership of the Learning Health Community would like to invite you to attend the upcoming webinar: Learning Health System-Essential Standards to Enable Learning (ESTEL). Read More »
- Login to post comments