Cytel Blog

On March 16, the World Health Organization (WHO) Director-General, Dr. Tedros Adhanom Ghebreyesus, in his media briefing on COVID-19, described the coronavirus pandemic as “the defining global health crisis of our time"^[1]. The pandemic has affected 176 countries and territories around the world. WHO is urging all governments to scale-up aggressive measures to combat COVID-19 as more cases and deaths are being reported across the globe. Until a vaccine is made available, social distancing is of the utmost importance to reduce transmission and enable health systems to cope.

The U.S. Centers for Disease Control and Prevention (CDC) defines social distancing as “remaining out of congregate settings, avoiding mass gatherings, and maintaining distance (approximately 6 feet or 2 meters) from others when possible” ^[2]. Governments in several countries have shut down public places such as parks, gyms, malls, schools, restaurants etc., for a minimum of 15 days, to be extended depending upon the situation.

In these circumstances, it is inevitable that companies worldwide also show solidarity by allowing their employees to work remotely, from the safety of their homes. In Seattle, the hub of many of America’s early COVID-19 cases, companies including Amazon, LinkedIn, Microsoft and Google advised workers to stop coming to office in late February ^[3]. With more employers taking this necessary and precautionary step, the question arises - how do we ensure that it is done right?

In honor of Rare Disease Day 2019 we share a new Cytel podcast featuring Cytel Strategic Consultant Ursula Garczarek discussing how innovative statistical approaches can overcome challenges in rare disease development. Below, you can access the podcast and a summary of some of Ursula's key insights from working in rare diseases and interacting with regulatory agencies for complex and innovative designs.

In 2018, Cytel ran a qualitative survey among biostatisticians and programmers on trends in data science and perceptions about the goals, barriers and future of the field in the biopharma and life science industry.  Our analysis and report revealed a range of insights from the respondents including :

Lack of shared understanding of what data science represents with less than 1 in 7 of all respondents suggesting a definition of data science.
Clear trend of investment in data science across organizational types with three-quarters of all respondents saying their organizations had a dedicated data science department.

An opportunity for improved clinical trial design by using data science techniques was recognized by the majority of respondents. In addition, respondents across all functions perceive the key opportunity for data science to be in maximizing the value of real-world data. 

In a recently published discussion on The Effective Statistician podcast ( a weekly podcast produced in association with PSI)  Ursula Garczarek, Associate Director Strategic Consulting at Cytel sat down with hosts Alexander Schacht and Benjamin Piske to discuss where the biopharma and life science industries are headed with the application of data science.

QPP remains at the heart of model based drug development. Short for Quantitative Pharmacology & Pharmacometrics, it refers to several types of quantitative modeling including meta-analysis, PK/PD, statistical modeling and the modeling of go-no-go decision rules. Cytel’s expert Quantitative Pharmacology and Pharmacometrics group delivers high quality solutions to help our customers get those decisions right.

In this blog we talk to Tina who lives in Stonington, Connecticut, to find out more about her career path, current role at Cytel, and her interests outside of work.

In this blog, we share a new infographic based on this popular blog post illustrating some of the critical interactions that need to take place between data management and statistics groups to help ensure efficiency and data quality. 

At the recent PCMG conference in Malta, Adrian Otte ( Independent Consultant, formerly VP Global Development Operations at Amgen) presented to delegates the strategic choices open to sponsors when  choosing an outsourcing model and the three fundamental issues in play: standardization, flexibility and cost. In Dr. Otte's view, standardization of systems and processes is key, but is often overlooked as a factor by companies of all sizes when deciding how to outsource clinical trial activities. In this blog, Dr Otte joins us to share his insights on this topic, as well as this views on how outsourcing has evolved in recent years, and the future trends that will have most impact. 

Data management is an essential building block for successful Immuno-Oncology (I-O) trials. At the Immuno-Oncology Clinical Trials operations meeting in New York in earlier this year,  Patti Arsenault, VP Quality Assurance at Cytel discussed with Christopher Lamplugh, AVP, Clinical Data Management, Global Data Operations at Merck, the key challenges for data management in the space, and what’s needed to overcome them. 

Photo by Agê Barros on Unsplash

by Natalie Fforde, Senior Director of FSP Services at Cytel

With effective use of outsourcing, sponsors are able to respond to market needs and change course where necessary, while ensuring a pool of highly qualified personnel are available to work on clinical trial projects. At Cytel we work with our clients to tailor the outsourcing model that works best for an organization's particular circumstances.
In this blog, I will take a look the Functional Service Provider ( FSP) outsourcing model and some of the key factors that can help make a partnership ‘tick’ successfully.

Cytel offers a full range of clinical data management services and the team of experts is spread across the globe.

In this blog we talk to Makarand, who is based in India, to find out more about his career path, current role at Cytel and his interests outside of work.