Perspectives on Enquiry & Evidence

Cytel's blog featuring the latest industry insights.

Featured post

Innovative Clinical Trial Design: Commercial vs Open-Source Software? Why Not Both?

In the ever-changing field of clinical trial design, there is often a need to evaluate design options quickly and efficiently. But when it comes to evaluating options, which is better: commercial or open-source software? And does it need to be a question of either-or?

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Perspectives on Enquiry and Evidence

September 25, 2023

Reducing Independent Data Monitoring Committee Timelines: A Focus on Formal Interim Analyses

As the pressure to reduce timelines rises across the industry, independent data monitoring committees (IDMCs) — which...

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September 13, 2023

Setting Expectations for Formal Interim Analyses with Independent Data Monitoring Committees

Independent data monitoring committees (IDMCs) review ongoing clinical trial data to make recommendations regarding...

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June 22, 2022

How to Determine if Your Clinical Trial Has Sufficient Data?

It can be difficult to estimate just how much time and data you need to address the multitude of considerations that...

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June 13, 2022

Driving Global Data Collaboration for COVID-19

The International COVID-19 Data Alliance (ICODA) was formed to address the challenge of generating rapid and rigorous...

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December 21, 2020

Year-End Roundup: Your Favorite Blog Posts of 2020

2020 has been an unusually difficult year as the global pandemic impacted all of our lives. This year, the Cytel blog...

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August 11, 2020

Optimizing Information in Trial Design and Implementation

While there is increasing optimism about the discovery of a COVID-19 vaccine, one of the less talked about aspects of...

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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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December 18, 2019

Year-End Roundup: Your Favorite Blog Posts of 2019

With only two weeks left for this fabulous year to end, we would like to thank all our blog subscribers and new readers...

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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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July 27, 2018

Infographic: 5 Key Interactions of Data Management and Statistics

In this blog, we share a new infographic based on this popular blog post illustrating some of the critical interactions...

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July 2, 2018

Highlights from the PSI 2018 Conference

A number of the Cytel team were in Amsterdam, 3rd- 6th June 2018 for the PSI Conference. This year’s conference was...

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April 25, 2018

Overcoming Data Management Challenges in Immuno-Oncology Trials

Data management is an essential building block for successful Immuno-Oncology (I-O) trials. At the Immuno-Oncology...

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February 28, 2018

Insight into the Coordination of Rare Diseases at Sanford registry

There is a consensus in the industry that data on rare diseases is limited, incomplete, and difficult to find or...

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November 15, 2017

Creating Efficiencies in the Vendor Qualification Process: A Proposal

Each year Halloran Consulting Group hosts‘CORE’ (Clinical Operations Retreat for Executives) as a forum for industry...

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October 27, 2017

Design Concept for Confirmatory Basket Trial Interview with Bob Beckman: Part 2

In this blog, we share the second part of our interview with Bob Beckman, about a design concept for a confirmatory...

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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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July 11, 2017

Collaboration Brings Success for the UK Adaptive Designs Working Group.

The Adaptive Designs and Multiple Testing Procedures Workshop (ADMTP), the first joint meeting of the Adaptive Designs...

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March 15, 2017

The Data Management Plan Takes Center Stage- why is it so important?

A precise and thorough approach to planning is key for success in data management. The Data Management Plan (DMP) is a...

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February 15, 2017

Outsourcing success for emerging biopharma

Outsourcing solutions should never be a one size fits all process, and smaller and emerging biopharma companies may...

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February 6, 2017

The Making of a CDISC Trainer

CDISC is a global, nonprofit charitable organization whose mission is ‘to inform patient care and safety through higher...

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December 21, 2016

CDISC submissions- are you up to speed?

December 18th 2016 was a significant date for the pharmaceutical industry and regulatory submissions. For trials which...

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December 20, 2016

How do CDASH standards build data quality?

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

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December 6, 2016

Ensuring quality data no matter the phase: data management considerations

The management of quality clinical data collection is built on a number of core essentials- including project...

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October 7, 2016

Adaptive Designs: A Data Management Perspective

Adaptive designs have the potential to accelerate clinical development, and improve the probability of trial success....

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August 2, 2016

The CRO role in Data Standards Governance

Editor's note( this blog was refreshed in April 2018) As CDISC compliant submissions become increasingly expected,...

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July 28, 2016

6 steps to timely database lock

To close a clinical database right the first time you have to begin with study start-up. Clearly, you can’t close a...

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July 12, 2016

Key considerations in selecting an EDC system

How do you go about selecting the best Electronic Data Capture (EDC) system for your study? There is now a vast amount...

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June 14, 2016

Managing DMC analysis- an innovative programming solution

At Cytel, we are very often asked to get involved in DMCs ( Data Monitoring Committees) in a variety of capacities. Our...

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May 19, 2016

Pattern Recognition and 'Big Data'

The explosion in healthcare information and “big data “has been one of the most written about topics in the last few...

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May 12, 2016

Lost in Traceability- From SDTM to ADaM

Once upon a time Hansel and Gretel laid a trail of breadcrumbs which they followed to find their way back home. Their...

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April 26, 2016

Overcoming Data Management Challenges in Oncology Studies

In this blog we’ll highlight some unique challenges that are encountered from a Data Management perspective when...

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April 20, 2016

Handling CDM data integrations

During the course of any clinical trial, there are often data which, while collected electronically, are outside of the...

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April 15, 2016

5 Key Interactions of Clinical DM and Statistics

It's critical for biostatistics and data management to be closely aligned and working effectively together. The...

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February 26, 2016

Getting Technical: The evolving role of the Data Manager

Remember the early days of Electronic Data Capture? Those first systems, which were revolutionary for their time...

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December 1, 2015

Making the Most of Data Management for Risk Based Monitoring

Risk based monitoring is a strategic monitoring practice which aims to shine the spotlight on problematic study areas,...

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August 13, 2015

Do you really need a full service CRO? An exploration of strategic options

Full service or specialized? Full service or specialized? For many looking to hire a CRO, the answer is obvious....

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August 10, 2015

Mitigate Phase 3 Clinical Trial Risk by Optimizing Phase 2 Data

When approaching a Phase 3 clinical trial, the need to ‘de-risk’ the massive investment often leads sponsors on a quest...

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