
Perspectives on Enquiry & Evidence
Cytel's blog featuring the latest industry insights.

June 15, 2022
For years CDISC data standards implementers have struggled to find good implementation examples and use cases beside...
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April 25, 2022
Insights on the New ADaM guidelines and Europe Interchange 2022
I am excited to see you all at the CDISC Europe Interchange, April 27 – 28 but unfortunately, it will be a virtual...
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February 18, 2022
WINTER WEEKEND READ: Role of Data Strategy in Clinical Development Success
Data is the most crucial asset of any clinical trial and hence, sponsors cannot jeopardize collecting clean...
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February 17, 2022
A Data Manager’s Role in Supporting a Rare Disease Clinical Study
It is a common perception that the role of a Data Manager is only to perform what we call “Data Cleaning”; making sure...
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February 11, 2022
WINTER WEEKEND READ: Tops Tips and Tricks from the Good Data Doctor
Adopting data standards such as CDISC in the early phase of clinical drug development contributes to the consolidation...
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February 9, 2022
How can an optimized data strategy support your clinical program?
Data is the cornerstone of any clinical trial and is used to ultimately drive the decision-making process related to...
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January 26, 2022
Career Perspectives: Interview with Jessica Bhoyroo, Clinical Data Manager
In this edition of the Career Perspectives series, I interview Jessica Bhoyroo, Cytel Clinical Data Manager based in...
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January 25, 2022
Watch out, the FDA Rejection Criteria are Now in Place
In this blog, I share some experiences we recently had during an FDA submission Cytel performed for a sponsor after...
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December 15, 2021
CDISC SDTM and ADaM: An Explosive 2021 Ending!
Recently, on November 29 I received an email from CDISC announcing an important update for both SDTM and ADaM CDISC...
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November 30, 2021
The FDA “Real-Time Oncology Review” Process
The FDA “Real-Time Oncology Review (RTOR)”[1] is an “FDA project started in 2018 to facilitate earlier submission of...
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October 5, 2021
The Importance of Traceability
Traceability is crucial in all steps of clinical data handling, from data collection to final analysis. The importance...
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August 31, 2021
CDISC Certification - is it worth taking?
For years, I have been telling the recruiters at Cytel to be wary of candidates claiming to have a CDISC Certification...
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July 30, 2021
In a Virtual Room with the FDA Reviewers
I had recently (for the first time) the pleasure and honor to attend a virtual meeting with the FDA, a pre-NDA Type-B...
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July 20, 2021
Career Perspectives: Interview with Anil Golla, Vice President, FSP
Anil Golla is Vice President, Functional Service Provision (FSP) at Cytel. After 17 years of working at pharmaceutical...
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June 14, 2021
Practicalities of Integrating Electronic Health Records into Data
ACDM’s (Association for Clinical Data Management) eDigital data management expert group (DMEG) focuses on driving...
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April 26, 2021
Why you should not miss 2021 Virtual CDISC EU Interchange?
As we all continue to take necessary precautions against the spread of COVID-19 virus, this year again the CDISC EU...
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March 30, 2021
The Integration Dilemma
As of today, our Industry has not defined any approach, nor does an official regulatory agency...
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February 24, 2021
Avoiding Lost-in-Translation with Submission Terminology
In a previous post, I discussed the importance of proper use of CDISC Controlled Terminology (CDISC CT) in SDTM....
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January 28, 2021
A little walk in the CDISC Library, hand in hand with SAS
The Christmas break presented an opportunity to make my first concrete steps into the CDISC Library. Overall, it was a...
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January 19, 2021
Cytel COVID Panel: Long-term Changes to Clinical Trials Due to the Pandemic
As we enter 2021 with new COVID-19 vaccines and greater optimism about the pipeline of drugs and devices positioned for...
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December 18, 2020
Submitting Software Programs to the Regulatory Agencies
Can I submit software programs other than SAS? What software programs should I submit? Are sponsors required to submit...
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November 23, 2020
Data Standards and Submission Highlights from PHUSE EU CONNECT 2020
The Virtual PHUSE-EU CONNECT Conference was held from November 8 to 13 and the event was a great success, despite all...
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November 19, 2020
10 Key Qualifications for Independent Statisticians Reporting to the DMC
Data Monitoring Committees (DMCs) are groups of independent experts who periodically receive (by-arm) reports created...
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November 3, 2020
Staffing Needs for RWE Delivery
When an expert statistician is paired with an experienced set of data managers, opportunities to capitalize on...
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October 28, 2020
When your ADaM package is not traceable back to SDTM
About three years ago, Cytel was helping a sponsor on a project where I had to conduct surveillance of some CRO...
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October 13, 2020
Introducing Observational Studies – Three Trends for Statisticians
The combination of greater access to electronic health records, bigger electronic claims datasets, and the need for...
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October 7, 2020
RWE Needs for Natural History Studies
With the rise in digital technologies, there has been an explosion in the volume and type of data sources. We can...
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March 5, 2020
Managing risk in clinical development: Is your data strategy fail-safe?
Generating high-quality clinical data is a vital but challenging task in modern drug development. Unfortunately, in the...
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February 20, 2020
Unlock the power of your clinical data with these five top tips
It is widely acknowledged among drug developers that one of their most important assets is the data generated during...
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February 6, 2020
Is your data strategy set up to tackle key challenges in early clinical development?
In clinical development, a high-quality evidence package is a prerequisite for a new therapy to gain approval from...
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January 22, 2020
What could you accomplish with a fresh approach to your clinical data strategy?
In the quest for clinical success, we all strive for evidence packages of the highest quality. If the clinical data is...
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January 8, 2020
How to optimize your data strategy to drive success in clinical development
In clinical development, data is the vital ‘foundation’ that supports your programs. To successfully bring a promising...
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December 16, 2019
Career Perspectives: Interview with Ronald Dumpit, Data Coordinator
Cytel Inc. and Axio Research joined forces in June 2019, expanding our ability to solve the most complex analytical...
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December 10, 2019
Impact of AI on Clinical Development
In association with Statisticians in the Pharmaceutical Industry (PSI) , UCB and Cytel hosted a symposium on September...
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November 27, 2019
Interview with David Kerr: Data Monitoring Committees (DMCs) – Behind Closed Doors
At the 2019 Challenges in Rare Diseases Clinical Trials Symposium and East training, Cytel partnered with Alexion to...
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September 12, 2019
Digital transformation in healthcare and drug development
"If you went to bed last night as an industrial company, you're going to wake up today as a software and analytics...
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April 24, 2019
Assuring Outsourcing Obligations with Specialist Data Management Oversight
In this blog, Alla Muchnik, Senior Clinical Data Manager at Cytel, discusses how specialist CROs can add value and...
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April 10, 2019
Ensuring Robust ePRO Implementation: Factors for Success
In this blog, Jonathan Pritchard, Director Business Development at Cytel, draws on his experience in commercial,...
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March 20, 2019
Operation Rescue: Addressing Lagging Trials
No one plans to have a trial whose data collection needs rescuing. However, lagging enrollment rates, operational...
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January 30, 2019
Career Perspectives: Interview with Tina Checchio, Associate Director, Quantitative Pharmacology & Pharmacometrics
QPP remains at the heart of model based drug development. Short for Quantitative Pharmacology & Pharmacometrics, it...
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June 14, 2018
What makes a good data manager?
In this blog, Paul Fardy, Executive Director of Data Management at Cytel shares his thoughts on how the data manager...
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April 18, 2018
Developing the Next Generation of Skills for Statistical Programmers
Our recent Clinical Biometrics Survey explored the views of respondents from across the statistical programming,...
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March 14, 2018
What makes a Successful FSP Partnership Tick?
Photo by Agê Barros on Unsplash by Natalie Fforde, Senior Director of FSP Services at Cytel With effective use of...
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November 22, 2017
Career Perspectives: Interview with Makarand Deshmukh, Senior Clinical Data Analyst
Cytel offers a full range of clinical data management services and the team of experts is spread across the globe. In...
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August 2, 2017
Case Study: Cross-study Efficiencies in Biometrics Outsourcing
As a biometrics -focused CRO, Cytel regularly works across a program of studies, providing data consistency, and...
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