In this blog, Paul Fardy, Executive Director of Data Management at Cytel shares his thoughts on how the data manager role has evolved. 

Topics: big data, Biometrics, real world evidence, clinical data management, clinical trials

 

To mark the occasion of our 30th anniversary, in late 2017 we conducted a brief survey to gain a snapshot of what professionals in data management, statistical programming, and biostatistics feel are the key challenges facing their functions, the top areas for skills development, and the clinical data areas they believe are likely to have the greatest impact on drug development.

We are now...

Topics: Statistical Programming, biostatistics, SAS, Biometrics, clinical data management

Statistical programmers at all levels can make a significant impact on streamlining delivery, improving efficiency, and importantly ensuring quality.  At a recent PhUSE Single Day event , Cytel's Sunil Gupta gave a very well received presentation on how best to achieve high quality deliverables while maintaining efficiency, noting that 3 key components should be observed:

Topics: Statistical Programming, biostatistics, Biometrics

Outsourcing solutions should never be a one size fits all process, and smaller and emerging biopharma companies may  have different priorities and processes when working with external vendors to larger pharmaceutical organizations.

Topics: outsourcing, Clinical Data, data manager, biostatistics, Biometrics, RFP

 

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

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...

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

 

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

In this blog we’ll highlight some unique challenges that are encountered from a Data Management perspective when working on early phase Oncology trials. We’ll also discuss approaches which can be employed to mitigate these issues.  

Topics: Oncology, Data Management, Clinical Research Services, Phase 1, Clinical Data, phase 2, EDC, database build, data manager, CDM, Biometrics

It's critical for biostatistics and data management to be closely aligned and working effectively together. The consequences when these biometrics teams aren't integrated can be significant-  impacting on both efficiency and data quality.  If data is collected and cleaned without the input of statistics, the assumptions which have been made may not be adequate, resulting in additional work and...

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