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The CRO role in Data Standards Governance

Posted by Cytel

Aug 2, 2016 10:30:00 AM

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 topic in the industry.

It has traditionally been common practice for biopharma companies to outsource their CDISC conversion of legacy data for the purpose of publications and submissions to expert CROs.  While large biopharma organizations may have dedicated in-house teams deployed to the management of standards governance, the dynamic nature of CDISC requirements means companies can struggle to find the resources to keep up to date and provide the best interpretation of the documentation. Outsourcing can be an option to ensure dedicated staff are available to manage and monitor these aspects and ensure companies remain submission ready.

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


6 steps to timely database lock

Posted by Cytel

Jul 28, 2016 10:06:00 AM

To close a clinical database right the first time you have to begin with study start-up. Clearly, you can’t close a database if the data is not cleaned and you can’t have clean data unless you know what is most important for analysis. It’s imperative that data management works closely with the statistics group during CRF/ eCRF design to ensure data is being collected and data checks are being written in a meaningful fashion. But that’s still not enough. The data should be cleaned on a regular basis and forms locked as soon as the data has been SDVd and reviewed. Even then, it will be important to have your statistics team run listings and tables early on to catch anything unexpected. If the data is cleaned and locked by the time the last patient visit comes around then getting Principal Investigator sign-off and ultimately closing the database can run much more smoothly and quickly.

Database lock is a significant milestone in the clinical trial, upon which further data analysis and reporting timelines depend.  The Clinical Data Manager is responsible for steering the data management process to ensure that the database is locked on time, and correctly.  In this blog we lay out the 6 steps to database lock success.

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Topics: Data Management, Clinical Research Services, Clinical Data, EDC, database build, data manager, big data


5 trends a statistical programmer needs to follow

Posted by Cytel

Jul 25, 2016 12:00:00 PM

Statistical programmers are in high demand within the biopharmaceutical industry, and within the dynamic world of clinical trials the part they play is ever evolving.  In this blog, we take a look at 5 trends which are shaping their roles in 2016 and beyond. 

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Topics: Statistical Programming, CDISC, big data, SAS, R programming


Webinar Replay: Single and Double Agent Dose Escalation Designs

Posted by Cytel

Jul 21, 2016 6:30:00 AM


Did you miss our webinar on Single and Dual Agent Dose escalation designs earlier in the year?  In this blog we have made the replay available for your review, and  also  take the opportunity to recap key reasons why you should consider a model based design for your dose escalation study.

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Topics: Oncology, Dose-Escalation, Bayesian Methods, EAST 6.4


5 session picks for the JSM

Posted by Cytel

Jul 20, 2016 8:30:00 AM

The Joint Statistical Meetings is the largest and arguably most highly respected gathering of statisticians in the world.  It will bring together over 6000 statisticians for this year’s event in Chicago.   As a large meeting, it can be a challenge to navigate and find the sessions which are going to be most valuable for your work.  To help out, we've asked some of the leading lights of our statistical group which sessions are their top picks this year. 

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Topics: Oncology, Trial Design, biostatistics, adaptive trials, Biometrics, JSM


Adaptive Design in the limelight with NEJM article

Posted by Cytel

Jul 18, 2016 8:00:00 AM

In order for adaptive designs to reach their potential, it’s critical that knowledge is effectively dissemirnated within the medical research community – in particular detailed information about the operating and statistical characteristics of specific designs and insights as to their benefits and limitations. 

Cytel recently announced the publication of an important article in the New England Journal of Medicine which takes a leap forward in promoting better understanding of adaptive designs particularly in a confirmatory setting.  We'll discuss some of the highlights of the article in this blog. 

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Topics: sample size re-estimation, Phase 3, Adaptive Clinical Trials, phase 2, biostatistics, adaptive designs, Seamless designs


Key considerations in selecting an EDC system

Posted by Cytel

Jul 12, 2016 9:00:00 AM

 How do you go about selecting the best Electronic Data Capture (EDC) system for your study?  There is now a vast amount of choice in the market, and many factors to take into account before making your decision.  Different stakeholders within the business may also have different perspectives, so any decision making process needs to balance these disparate needs.  

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Topics: Data Management, Clinical Research Services, Clinical Data, EDC, database build, data manager, CDM


Wild Horses: How StatXact is helping conservation project in Mongolia

Posted by Cytel

Jul 7, 2016 10:30:00 AM

 

Why do we do what we do?  At Cytel we have always been driven to deliver benefits in the service of human health, and ultimately to bring new drugs to the patients who need them.  In the context of our work in statistical software, we have recently had the opportunity to support an important conservation project defined by a similar passion to make a difference.  

While our core focus has always been in biostatistics, and thus in the life science industry, our StatXact statistical software is used by customers across a broad spectrum of natural and social sciences thanks to its ability to handle small sample sizes. 

 

The Association Takh is one such customer.  Takh is dedicated to the re-introduction of the world’s last wild horse, as well as conservation in Mongolia and improvement of the lives of Mongolian herders.  (1) In 2004 and 2005 the association reintroduced 22 Przewalski’s horses( one of the world’s most endangered species)  from Le Villaret in southern France to the buffer zone of Khar Us Nuur National Park in the Khomyn Tal herder community of western Mongolia.

 

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Topics: StatXact, Statistical Programming, exact statistics, Simulations, biostatistics, non parametric analysis


PROC MCPMod in Bronchodilator Case Study

Posted by Cytel

Jul 5, 2016 8:00:00 AM

 

At a recent PhUSE SDE, Cytel’s Chitra Tirodkar presented how East PROC MCPMod could be used  to  help solve the problem of uncertain true dose-response relationship in a bronchodilator study.  In this blog we summarize some of the issues, and make Chitra's slides available for download. 

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Topics: East, Statistical Programming, Dose-Finding, Dose Selection, MCP-Mod, EAST 6.4, SAS


The Rise of R-should SAS programmers get up to speed?

Posted by Cytel

Jun 29, 2016 8:00:00 AM

 

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Topics: Statistical Programming, Simulations, biostatistics, SAS, R programming


Getting the best out of your biometrics RFP

Posted by Cytel

Jun 23, 2016 7:21:06 AM

 

Vendor selection is a critical component of ensuring clinical trial success.  A 2015 report (1)  suggested that clinical outsourcing penetration will reach 72% by 2020- nearly 3 quarters of all clinical trials will be outsourced to professional CROs.  The process of vendor selection and management may be managed by the clinical operations teams within smaller companies, or by outsourcing and functional groups within larger organizations.  The RFP process is a critical part of vendor evaluation, involving significant effort from the sponsor and CRO to ensure that a well-constructed, accurate proposal is created which can deliver what the sponsor needs.

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Topics: Clinical Research Services, outsourcing, Clinical Development Strategy, EDC, database build


Sharpening your Advanced SAS Skills: Interview with Sunil Gupta

Posted by Cytel

Jun 21, 2016 10:30:00 AM


Sunil is an Associate Director of Statistical Programming at Cytel and has over twenty-five years of experience in the pharmaceutical industry.  He is also an international speaker and best-selling SAS author.  Most recently, Sunil contributes his knowledge as a CDISC Oncology ADaM reviewer and has taught his CDISC online classes with the University of California at San Diego.  Sunil has MS in Bioengineering from Clemson University and a BS in Applied Mathematics from the College of Charleston.
Recently, Sunil published a book, 'Sharpening your Advanced SAS Skills’ a follow up to his popular and well respected ‘ Sharpening your SAS Skills’. In this blog we find out more and offer blog readers the chance to win a copy of the new book!

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Topics: Statistical Programming, Training and Education, biostatistics, SAS


Determining the future course of your trial

Posted by Cytel

Jun 16, 2016 10:23:00 AM

 Predicting the course of a clinical trial is something which people will always want to do-whether for statistical reasons, planning reasons or business reasons. In this blog we look at examples of where prediction goes off course, and how we can resolve these issues.  We also share valuable video and slidedeck resources from our VP Consulting and Software, Yannis Jemiai.

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Topics: East, East PREDICT, Interim Analyses, Cytel Videos, Cytel Events, clinical development, EAST 6.4, adaptive designs, adaptive trials, DMC


Managing DMC analysis- an innovative programming solution

Posted by Cytel

Jun 14, 2016 8:00:00 AM

At Cytel, we are very often asked to get involved in DMCs ( Data Monitoring Committees)  in a variety of capacities. Our statistical experts are recognized for their work in many of the areas related to DMCs including-group sequential and adaptive designs, multiplicity, missing data, and decision sciences.  One key operational management issue when producing analysis for DMCs  is that rules must be defined so that trial unblinding is not compromised and bias remains controlled.  In this blog, we will explore an innovative approach developed by members of our statistical programming team to improve the efficiency of this process, while maintaining the highest levels of data security. 

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Topics: Clinical Research Services, Statistical Programming, Interim Analyses, Blind and Unblind Trials, Clinical Data, ACES, biostatistics, DMC


How can the CMO/Biostatistician connection improve clinical development?

Posted by Cytel

Jun 7, 2016 8:00:00 AM

 At the recent CMO Summit East  James ( Jim) Bolognese, Cytel’s Senior Director of Strategic Consulting, and Lou Vaickus,MD, FACP, Founder and President of aktaPD jointly explored how the critical connection between a CMO and a biostatistician can help enhance communication with internal and external stakeholders, ensure patient safety and ultimately improve clinical development efficiency.  Below you can catch up with some of the key topics they covered and watch the video of the presentation. 

 

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Topics: Clinical Development Strategy, go-no-go, clinical development, biostatistics, p value


EAST 6.4 Release: Interview with Yannis Jemiai

Posted by Cytel

May 31, 2016 7:30:00 AM

 

Last week, we were delighted to announce the release of East 6.4 bringing further cutting –edge approaches to the East user community. East is the industry standard platform for clinical trial design, simulation, and monitoring, improving scientific productivity during the critical planning stages of clinical development. In this blog we catch up with Yannis Jemiai, VP of Cytel  to gain some behind-the-scenes insights into the development and  new features of this important release.

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Topics: East, Bayesian Methods, East PREDICT, Prediction, Software Simulations, Multi-Arm Studies, Multi-Arm Multi-Stage Studies, biostatistics, EAST 6.4, adaptive trials


Highlights from the PSI Conference

Posted by Cytel

May 26, 2016 11:37:20 AM

A number of the Cytel team were in Berlin 22nd- 25th May  for the PSI Annual conference.  The PSI Conference is an important forum for statisticians and we found this year's event to be energetic, technically interesting and well attended.  In this blog, we’ll summarise some of the particular highlights from the sessions that our team members attended.

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Topics: Clinical Data, biostatistics, adaptive designs, adaptive trials, PSI Conference


Pattern Recognition and 'Big Data'

Posted by Cytel

May 19, 2016 6:00:00 AM

The explosion in healthcare information and “big data “has been one of the most written about topics in the last few years. These big data in the form of electronic health records, diagnostic tests, genomics, proteomics, not to mention data from wearable devices and apps have the potential to transform healthcare.  That potential can only be realized though through the application of advanced analytics to recognize patterns from the vast information available. As such, disciplines such as pattern recognition play a pivotal role in the future of healthcare.

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Topics: Bayesian Methods, Computing, Clinical Data, biostatistics, machine learning, big data, pattern recognition


Scrambled Data – A Population PK/PD Programming Solution

Posted by Cytel

May 17, 2016 8:30:00 AM

Cytel participated at PharmaSUG 2016 in Denver recently.  A key event on the statistical programming global calendar, the topics included Submission Standards, Application Development and Data Visualizaton. Sharmeen Reza, Associate Director Statistical Programming at Cytel was selected to present a paper presentation in the Statistics and Pharmacokinetics stream on the topic of Scrambled Data- A Population PK/ PD Programming Solution.  The presentation was very popular and well attended, so we've included an abstract of the presentation  below, and made her slides available for download. 

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Topics: Statistical Programming, pharmacometrics, biostatistics, pharmacology


Lost in Traceability- From SDTM to ADaM

Posted by Cytel

May 12, 2016 10:18:00 AM

 

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 EU Interchange. 

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


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