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

What could you accomplish with a fresh approach to your clinical data strategy?

January 22, 2020

In the quest for clinical success, we all strive for evidence packages of the highest quality. If the clinical data is strong, then a promising new therapy is more likely to obtain approval from key stakeholders, such as regulators and payers . As a result, you’ll get the chance to develop a therapy that will help many patients (and you will likely gain returns on your investments). As we discuss in our new eBook on data strategy planning, a carefully planned data strategy can help mitigate risks to your programs and enable you to successfully achieve your goals.

Discover how to plan a data strategy that enhances your clinical programs and enables new therapies to reach patients in our new eBook.

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In the high-stakes environment of clinical development, it is never too early to start protecting your valuable data assets with a first-rate strategy. So, keep reading to learn which planning approach to use, who should be involved, when it is best to start, and why it is well worth going to all the effort.

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How to optimize your data strategy to drive success in clinical development

January 8, 2020

In clinical development, data is the vital ‘foundation’ that supports your programs. To successfully bring a promising new therapy to patients, the quality of your evidence must be strong enough to gain approval from key decision-makers, including regulators, payers, and health technology assessment (HTA) agencies.

So, how can you strengthen the quality of your clinical evidence package? A key solution is to optimize your data strategy. As we discuss in our new eBook on data strategy planning, making just a few small changes to your planning approach can strengthen your ‘foundation’ and generate various benefits that enhance and expedite clinical development.

Download our free eBook to find out how to optimize your data strategy to boost success in clinical development.

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Career Perspectives: Interview with Ronald Dumpit, Data Coordinator

December 16, 2019

 

 

Cytel Inc. and Axio Research joined forces in June 2019, expanding our ability to solve the most complex analytical challenges for the life sciences industry. Cytel offers a full range of clinical data management services delivered by advanced analytics experts with global reach.

In this blog, we talk to Ronald Dumpit, who is based in Bremerton, Washington to find out more about his career path, current role at Axio and his interests outside of work.


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Highlights from PhUSE EU Connect 2019

December 12, 2019

PhUSE EU Connect 2019 was held in the beautiful city of Amsterdam between the 10th and 13th of November. This clinical data science conference comprised 19 Streams, including 150 papers, 24 posters and 3 engaging data scientists as keynote speakers. The event was well attended and had several interesting and innovative presentations. Caroline Terrill, Associate Director of Statistical Programming at Cytel UK, conducted a session “No Place Like Home: Managing Remote Programmers Remotely” and stood out as the winner in the Personnel Management category. Based on 5 years' experience of managing remote programmers, Caroline’s paper gives guidance on issues to be considered and traps to be avoided if you are managing people who work remotely.

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

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Impact of AI on Clinical Development

December 10, 2019

In association with Statisticians in the Pharmaceutical Industry (PSI) , UCB and Cytel hosted a symposium on September 11, 2019 at UCB’s offices in Slough, Berkshire. The primary agenda was to educate the audience on Artificial Intelligence (AI) approaches and their impact on clinical development.

With recent advances in AI, it is important for quantitative scientists to keep up to date with the most recent methods and be involved in guiding their application to the most pressing analytical challenges. This one-day event covered cutting edge examples of how data science and statistical sciences are intersecting, and its relevance to our attendees.

“Artificial Intelligence and associated methodology is becoming increasingly important to the Pharma Industry and its technical foundation in statistical theory means that PSI is naturally keen to promote good practice through its membership and established Industry links. PSI is proud to have set up a Special Interest Group in this field and is keen to broaden its links and membership.”

- PSI Data Science special interest group

In this blog, we share some of the key takeaways from the symposium. If you are interested in attending similar sessions, you can check Cytel’s list of upcoming events here.

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Interview with David Kerr: Data Monitoring Committees (DMCs) – Behind Closed Doors

November 27, 2019

At the 2019 Challenges in Rare Diseases Clinical Trials Symposium and East training, Cytel partnered with Alexion to bring together expertise from academia and industry. David Kerr, Director of DMC Services at AXIO, was among the notable speakers and his talk “Data Monitoring Committees – Behind Closed Doors” covered general considerations and options that the DMC has when reviewing the data presentations during their closed sessions. He presented four specific case studies that highlighted the data provided to the DMC from meeting to meeting and discussed how the DMC arrived at their recommendations for each meeting. We had the opportunity to sit down with David and speak about Data Monitoring Committees, understand their proceedings and talk about his presentation at the symposium.

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Digital transformation in healthcare and drug development

September 12, 2019

"If you went to bed last night as an industrial company, you're going to wake up today as a software and analytics company," CEO of GE, Jeff Immelt

We are living in a new digital world which is evolving every day. Both personally and professionally, we rely on technology for many of our routine activities, and examples of digitization are prevalent across industries. Retail is a big example of how several chains have moved from physical stores to creating an online presence. In some years from now, people perhaps won’t have to learn driving as more self-driven cars will hit the road. Healthcare does not fall far behind in this race towards digitization.

In this blog, we will examine some of the different ways that digitization is set to shift the drug development paradigm.

 

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Assuring Outsourcing Obligations with Specialist Data Management Oversight

April 24, 2019

 

 

In this blog, Alla Muchnik, Senior Clinical Data Manager at Cytel, discusses how specialist CROs can add value and streamline processes by providing oversight of data management services delivered by another CRO. This model helps to fulfill essential regulatory obligations for biopharma companies who may lack their own internal oversight resources.

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