In this blog, Paul Terrill, Director of Strategic Consulting at Cytel outlines his blueprint for ensuring smooth communication between statistical and clinical stakeholders. Paul draws upon his 20 years of experience working as a statistician and his training background to share his guidelines for success. Whether you are a statistician looking to hone your project communication skills, or a...

Topics: clinical research, clinical trials, SDTM, biostatistics, Cytel Strategic Consulting, clinical development

 

This is the third in our blog series ' The Good Data Submission Doctor' in which Angelo Tinazzi, Director of Standards, Systems and CDISC Consulting at Cytel tackles key issues in preparing data for CDISC submission. In the previous “Good Data Submission Doctor” blog Angelo discussed his top 5 SDTM FAQ; in this article he turns his attention to the top FAQs for  ADaM. Read on for Angelo's...

Topics: clinical research, clinical trials, SDTM, ADaM, CDISC

 

In this second post of the “Good Data Submission Doctor” ( read my first post The Master Recipe: Quality and Attention to Detail Matter here) I would like to go through some of my favorite SDTM Frequently Asked Questions. These are questions I regularly receive in my capacity as a CDISC Subject Matter Expert, either from my colleagues or from the sponsor. Let’s start by taking a look at five...

Topics: clinical research, clinical trials, SDTM, ADaM, CDISC

Topics: CDISC, SDTM, Data Management, clinical data management

One of my wife’s favorite TV shows is ‘Quattro Ristoranti’ (Four Restaurants). In each episode of the show, 4 restaurants of the same style are assessed and the one getting the best evaluation wins the prize. One of the first things the TV presenter Alessandro Borghese, a famous Italian chef, does while visiting the restaurant is to assess (of course!) the kitchen and how much the kitchen and...

Topics: CDISC, SDTM, ADaM, PhUSE, Statistical Programming, FDA

 

CDISC is a global, nonprofit charitable organization whose mission is ‘to inform patient care and safety through higher quality medical research’.  The organization delivers this mission through the development of data standards designed to streamline clinical research- these standard formats are increasingly expected for use in data submissions by regulatory authorities. Importantly, data...

Topics: Clinical Data, Biometrics, Statistical Programming, CDISC, CDASH, SDTM, ADaM, Training and Education

 

As we prepare to say 'so long, farewell'  to 2016, we'd like to take the opportunity to thank all our blog readers and subscribers.  Read on for a  round up of our most read topics from the year.... 

Topics: Clinical Data, data manager, EDC, database build, adaptive trials, adaptive designs, SDTM, CDISC

 

December 18^th 2016 was a significant date for the pharmaceutical industry and regulatory submissions. For trials which commence after this date, the FDA will no longer accept non-CDISC data submissions for new drug applications ( NDAs) , certain investigational new drug applications, abbreviated new drug applications (ANDAs)  and certain biologics license applications (BLAs).

 The FDA...

Topics: Clinical Data, data manager, SDTM, CDISC, CDASH, Regulation

 

Data Standards play a crucial role in structuring and promoting long term value of clinical data.

Clinical Data Acquisitions Standards Harmonization or CDASH was developed with participation from all three ICH regions (US, Europe and Japan) with recommended data collection fields for 16 domains-> DEMOG, AE etc. It also includes  implementation guidelines, best practice recommendations, and...

Topics: Clinical Data, data manager, SDTM, CDISC, CDASH

In our last blog, we shared some of Angelo Tinazzi and Cedric Marchand's recommendations on how to ensure independence of QC in statistical programming.  Now, we've put together an infographic highlighting some key do's and don'ts in a handy checklist.  

Topics: Statistical Programming, biostatistics, SDTM, ADaM

Editor's note( this blog was refreshed in April 2018)

As CDISC compliant submissions become increasingly expected, biopharmaceutical companies are considering how to approach the issue of data standards governance.  Standards governance is a lynchpin in the management of CDISC compliance and is important for promoting standards awareness within organizations. It’s also an acknowledged hot...

Topics: Data Management, Clinical Research Services, Clinical Data, EDC, database build, data manager, CDM, Statistical Programming, SDTM, ADaM, CDISC, CDASH

 

Once upon a time Hansel and Gretel laid a trail of breadcrumbs which they followed to find their way back home.  Their story can be an allegory for the concept of traceability in clinical data where we need to  lay a clear path to ensure that the results we have created can be reproduced. This blog looks at some aspects of a presentation Lost in Traceability  by Angelo Tinazzi at the CDISC...

Topics: Clinical Research Services, Statistical Programming, FDA, Clinical Data, CDISC, SDTM, ADaM, EMA, PMDA, Biometrics

Last week was the CDISC EU Interchange conference in Vienna, a key event on the calendar for Cytel’s statistical programming subject matter experts . Angelo Tinazzi, Director, Statistical Programming, Clinical Data Standards and Clinical Data Submission at Cytel co-chaired the sessions on Foundational Standards and Standards Governance alongside Astrazeneca’s Daniel Graham, and delivered a...

Topics: Clinical Research Services, Statistical Programming, FDA, Clinical Data, CDISC, SDTM, ADaM, EMA, PMDA, Biometrics

Data standardization is critical to ensure successful regulatory submissions. While many sponsors now choose to create CDISC compliant outputs as part of their in-line study analysis and reporting, inevitably legacy conversion of older studies is required.

A legacy conversion project is one which requires a significant transformation effort, where neither CDASH nor SDTM has been used....

Topics: Statistical Programming, ISS, ISE, CDISC, SDTM