Evidence & Performance Blog

We almost all know what CDISC is. It is a consortium that develops and maintains clinical data standards, like SDTM (Study Data Tabulation Model) and ODM (Operational Data Modeling).

The purpose of SDTM is to store clinical trial data, in XPT format together with standardized and organized metadata.

The purpose of ODM is to store not only clinical data, but also all data belonging to clinical trials (protocol, queries, DCF, data, metadata, audit-trail …) in XML format.

On the other hand we have the HL7 standard. Standardized messages related to the electronic patient file used to exchange patient data across the hospital structure. Typically a record could contain patient’s information, their consultations, their prescriptions etc…

Those two different worlds try to get closer to each other; in fact they deal with the same information, because some of the clinical data is already captured in the patient’s record. It would be a high benefit if some data coming from the hospital could already be integrated in the clinical trial.

The BRIDG Model has been designed to link both clinical research data and patients file data.

Of course, both standards are quite different, so the challenge lies in the integration of one standard with the other.

Initiated a couple of years ago, the BRIDG project demonstrates that data integration is not easy, and cannot be done over a night.

But what will be done in a long term period? Keep both entities and bridge them together? Wouldn’t it be more profitable to have a unique standard for both? But is it feasible?

More information can be found here: HL7, CDISC, BRIDG.

Additional information can also be found here: http://www.clinpage.com/article/the_future_of_odm_sdtm_and_cdisc/C12

Datatrak is highlighting ease of access to site performance metrics as a key differentiator as it launches the latest version of its platform eClinical product suite.

The latest version of eClinical suite is tracking metrics on investigative site performance in clinical trials. Read more

LSIT (Life Sciences Information Technology)is a non-profit organization bringing together several industries to build the first Good Informatics Practices (GIP) guidance document to assist IT in 5 areas: compliance, standards, best practices, risk mitigation and return of investment. GIP is the guidance for improving quality and trust of IT within life sciences and healthcare.

GIP guidance document compiles standards in one reference guide for an IT system of a life science or healthcare environment.

All functions within a life science organization require significant use of multiple IT platforms. Their intellectual property, knowledge management and data are on IT systems that must be trusted and secure.

The integration of IT into Life Science and Healthcare has a “real potential for reducing both the time and cost of bringing new medical products from discovery to the patient. The one main inhibiting factor is “trust”. Trusting that these very complexes IT tools, computational processes, and resulting data are, in fact, accurate and scientifically valid, is critical for all stakeholders and gatekeepers alike”.

More information is available on http://www.lsit.org/

We recently covered the topic about dispersed and disparate data.
Within one company, if you have a horizontal view across all trials, you will notice that data is stored in various formats, including diverse relational databases, text files, XML files, spreadsheets and certainly proprietary storage formats. There is no unique way of collecting, organizing and analyzing data.
The problem is to utilize of this critical data to assess the trial’s or program’s performance. Read more

Does the clinical trial area need performance tools? YES!
More and more companies start to think of a more efficient way to run clinical trials. What they want is easy: reduce the costs, reduce the time, and enhance the productivity.
How can they achieve this goal? By measuring the performance of the clinical trials and the service providers (Lab, EDC and other vendors, R&D …). Read more

Document management and document control are important parts of clinical quality operations. The Safe association wants to move to a fully electronic business environment by 2012.

Read more