Automating clinical trials: Why it’s essential for success. Many companies in the life sciences industry are slow to adopt new technologies. This is down to greater costs, greater operational burden, and
A guide to CDISC standards used in the clinical research process. The Clinical Data Interchange Standards Consortium is an organization dedicated to helping to improve medical research by driving communication through
What is clinical trial software? It’s software that’s used by CROs, biotechnology, and pharmaceutical companies to facilitate clinical trials from conception to finish. For example protocol management, CRF design, metadata management,
Enabling data science to support cell therapy clinical trials. In this case study, Ian Hollingsworth, the Programme Manager for the ATTC (Advanced Therapy Treatment Centres), looks at the collaborative partnership that
What’s the background on CRFs? A traditional paper case report form is known as a CRF (or paper CRF). An electronic case report form (eCRF) is the same as a CRF,
The life sciences data interoperability revolution is here with eClinical Solutions’ expanded clinical data platform. elluminate addresses key industry data challenges with expanded connectors to popular clinical systems. Mansfield, MA, June
All you need to know about SDTM. The SDTM standard is a CDISC standard, and it means the Study Data Tabulation Model. If you want to know more about CDISC
9 SDTM Mapping Scenarios you need to know. One of the most challenging programming problems in a clinical trial involves SDTM mapping. That is mapping datasets from a non-CDISC structure to
What are SDTM supplemental qualifiers? Another blog on the 9 SDTM mapping scenarios you need to know ended on the cliffhanger of the supplemental qualifier! These are variables in non-CDISC
How to Describe Multiple Origins for a Value in Define-XML 2. There are many common questions people have when creating Define-XML metadata for their datasets. One of these revolves around how
The Clinical Data Interchange Standards Consortium is an organization dedicated to helping improve medical research by driving interoperability through data standardization. Formedix has been strong advocates for the use of CDISC data
How CDISC standards fit into the drug development process. The clinical trial process is a long, expensive, complicated one that often ends in failure. That means to have a successful outcome,
3 things you should know about ADaM standards. One of the most important standards when it comes to clinical trial submission, the Analysis Data Model (ADaM) outlines how to create analysis
Using NCI Controlled Terminology for Standardizing Data. The use of consistent terminology within and between studies is critical to enabling an efficient trial process. CDISC standards such as CDASH, SDTM, SEND
What CDISC standards are required for regulatory submissions? It’s a pretty safe bet that most people’s first introduction to CDISC is through the Study Data Tabulation Model (SDTM). This is a
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Formedix is an all-in-one fully integrated platform to design and build your clinical trial – without any coding knowledge.
Made for pharmas, biotechs and CROs, the Formedix metadata repository and clinical trial automation software makes it quick and easy to find, manage, reuse and share your metadata. The result? You can design, build and submit your trials much faster than before.
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