The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.

The Good Data Submission Doctor - New ADaM Implementation Guidance

October 23, 2019

 

 
October 3, 2019 was an important day for the ADaM team as it marked the release of the ADaM Implementation Guidance (Ig) 1.2. Download the new guidance from the CDISC website here.


In 2018, several previews of the new Ig were made at CDISC Interchanges all around the world and at PhUSE conferences, it was only a few weeks ago that the final version was released. At first glance, the new Ig does not seem to contain a lot of new concepts and ideas. However, a critical and in-depth review clearly shows the efforts of the entire team to release this new Ig. Creating a new standard or releasing a new version of an existing standard is not an easy job. You need to ensure that you do not introduce anything that contradicts any of the existing CDISC standards. This includes, not only new variables but also any changes in existing sentences or adding entirely new sections that may cause misinterpretations or discrepancies. Moreover, every standard team member comes with their own background, company needs, and specific indication needs. It is not always easy to propose a solution that can satisfy everyone on the team.

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Career Perspectives: Jayshree Garade

August 7, 2019

 

 


In this blog, from our career perspectives series,  we talk with Jayshree Garade Associate Director, Statistical Programming about her truly global career path at Cytel.  Jayshree completed her Masters degree in 2006 and began her professional career with Cytel in Pune India. In the years to follow she supported high profile trials for a number of sponsors, before transferring to our offices in Massachusetts USA. She is currently leading a programming team, working remotely from her North Carolina home.  Read on to learn more about life and opportunities at Cytel. 

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Career Perspectives: Interview with Tina Checchio, Associate Director, Quantitative Pharmacology & Pharmacometrics

January 30, 2019

QPP remains at the heart of model based drug development. Short for Quantitative Pharmacology & Pharmacometrics, it refers to several types of quantitative modeling including meta-analysis, PK/PD, statistical modeling and the modeling of go-no-go decision rules. Cytel’s expert Quantitative Pharmacology and Pharmacometrics group delivers high quality solutions to help our customers get those decisions right.

In this blog we talk to Tina who lives in Stonington, Connecticut, to find out more about her career path, current role at Cytel, and her interests outside of work.

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Highlights from the PhUSE EU Connect

December 11, 2018

PhUSE EU Connect 2018 took place in Germany’s financial capital Frankfurt, 4th - 7th November and brought together a range of experts to tackle the most pressing issues facing statistical programmers today. The agenda was superb with 143 presentations in 16 different streams and nearly 30 posters. This year’s event theme ‘Future Forward’ did not disappoint and there were some very thought-provoking talks on the drug development industry's challenges and  what we can do in the future to meet these challenges. Additional hot topics were: Analytical Risk Based Monitoring, Machine Learning, and Data Standards and Governance. We found this year's event informative and well attended. 

In this blog, we share the contributed posters and presentations from our Statistical Programmers and summarize some of the particular highlights from the sessions and posters that our team members attended.

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Career Perspectives: Interview with Munshi Imran Hossain, Senior Data Scientist

October 23, 2018

Cytel data scientists apply advanced statistical techniques including predictive modeling of biological processes and drug interactions to unlock the potential of big data.

In this blog we talk to Munshi Imran, who is based in Pune, India to find out more about his career path, current role at Cytel and his interests outside of work.

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The "Master Recipe": Quality and Attention to Details Matter When Submitting CDISC Packages to Authorities

October 1, 2018

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 its tools are cleaned. This assessment could have a big impact on the final outcome regardless of the quality of the food served in the restaurant .... the state of the kitchen and its cleanliness influences Borghese’s faith in the chef’s work.

This is exactly what could happen in a data submission to health authorities such as the FDA: the efficacy and safety of your drug are of course what matter, but lack of traceability, or poor or insufficient documentation might trigger questions and concerns from the reviewer. While this might not impact the overall final outcome of your submission, approval could be delayed if the reviewer starts questioning what you have done by requesting changes, or new deliverables to clarify the aspects that were not sufficiently clear in your original submission.

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