Nand Kishore Rawat is a Director and Head, Early Phase Biostatistics based in the King of Prussia, PA Cytel office. We recently spoke with Nand for the Cytel podcast to gain his thoughts on the unique aspects of Phase 1 development and where innovative approaches supported by thorough planning can meet these challenges head-on. Read on for key insights or listen to the podcast.
Read More
Topics:
clinical research,
clinical trials,
biostatistics,
Cytel Strategic Consulting,
clinical development,
Phase I,
pharmacometrics,
quantitative decision-making
Happy New Year! As we look ahead to future successes and the new advancements in drug development that 2019 will bring, we are taking a moment to reflect on the topics that resonated most with our community on the Cytel blog in 2018. While these 6 most popular blogs encompass a variety of topics from across the data science, statistics, and statistical programming space, they all have in...
Read More
Topics:
clinical research,
clinical trials,
adaptive trials,
feature selection,
Clinical Data,
CDISC,
meta-analysis,
data science
In this blog, Paul Terrill, Director of Strategic Consulting at Cytel outlines his blueprint for ensuring smooth communication between statistical and clinical stakeholders. Paul draws upon his 20 years of experience working as a statistician and his training background to share his guidelines for success. Whether you are a statistician looking to hone your project communication skills, or a...
Read More
Topics:
clinical research,
clinical trials,
SDTM,
biostatistics,
Cytel Strategic Consulting,
clinical development
This is the third in our blog series ' The Good Data Submission Doctor' in which Angelo Tinazzi, Director of Standards, Systems and CDISC Consulting at Cytel tackles key issues in preparing data for CDISC submission. In the previous “Good Data Submission Doctor” blog Angelo discussed his top 5 SDTM FAQ; in this article he turns his attention to the top FAQs for ADaM. Read on for Angelo's...
Read More
Topics:
clinical research,
clinical trials,
SDTM,
ADaM,
CDISC
In this second post of the “Good Data Submission Doctor” ( read my first post The Master Recipe: Quality and Attention to Detail Matter here) I would like to go through some of my favorite SDTM Frequently Asked Questions. These are questions I regularly receive in my capacity as a CDISC Subject Matter Expert, either from my colleagues or from the sponsor. Let’s start by taking a look at five...
Read More
Topics:
clinical research,
clinical trials,
SDTM,
ADaM,
CDISC
Cytel data scientists apply advanced statistical techniques including predictive modeling of biological processes and drug interactions to unlock the potential of big data.
In this blog we talk to Munshi Imran, who is based in Pune, India to find out more about his career path, current role at Cytel and his interests outside of work.
Read More
Topics:
Statistical Analysis,
careers,
clinical research,
Statistical Programming,
CRO,
Recruitment,
Cytel Strategic Consulting,
adaptive designs,
Adaptive Clinical Trials,
clinical trials,
Regulation,
big data,
Trial Design Software,
Software Simulations,
genetic algorithm
The Society for Clinical Data Management (SCDM) conference brought clinical data managers from around the world to Seattle-Bellevue, WA on September 23-26. The conference offered an unmatched opportunity to discover innovative solutions in the clinical data management industry. In this blog, we will share our data management colleagues' experiences, observed trends and contributions to the...
Read More
Topics:
clinical data management,
data manager,
Clinical Data,
clinical research,
clinical trials,
clinical development,
CDM
At Cytel we believe that expert statistical input has the power to shape the future of clinical development: de-risking portfolios, accelerating timelines, and increasing the probability of success.
In this blog we talk to Adam who lives in North Carolina United States to find out more about his career path, achievements, current role at Cytel and his interests outside of work.
Read More
Topics:
Statistical Analysis,
careers,
clinical research,
Statistical Programming,
CRO,
Recruitment,
Cytel Strategic Consulting,
biostatistics,
adaptive designs,
Adaptive Clinical Trials,
clinical trials,
Regulation
EnForeSys is Cytel’s tool for patient recruitment planning. We have discussed on the blog recently with Tufts University's Center for the Study of Drug Development, Ken Getz, the problem the industry continues to face with patient recruitment, and the fact that most trials significantly exceed their original planned duration. In the face of this problem there's a pressing need to create more...
Read More
Topics:
patient enrollment,
enforesys,
clinical trials
Cytel has grown significantly over the last 30 years, with operations across North America, Europe, and India. All of our processes, talent, and expertise are applied to maximizing the value of clinical data. At Cytel, quality comes first, and our QA team are committed to ensuring processes are in place to support our services.
In this blog we talk to Meredith who lives in Somerville,...
Read More
Topics:
Statistical Analysis,
careers,
clinical research,
Statistical Programming,
CRO,
Recruitment,
Cytel Strategic Consulting,
biostatistics,
adaptive designs,
Adaptive Clinical Trials,
clinical trials,
Regulation,
Trial Quality
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.
Read More
Topics:
big data,
EDC,
data manager,
Clinical Data,
database build,
Clinical Research Services,
Data Management,
clinical trials,
Statistical Analysis
At Cytel our strategic consulting team works on a wide range of projects including: Identifying the best clinical trial design, implementing adaptive designs, developing a regulatory strategy and interacting with regulators.
In this blog we talk to Sam who lives in the Boston area, to find out more about his career path, current role at Cytel, industry experience and his interests outside of...
Read More
Topics:
Statistical Analysis,
careers,
clinical research,
Statistical Programming,
CRO,
Recruitment,
Cytel Strategic Consulting,
biostatistics,
adaptive designs,
Adaptive Clinical Trials,
clinical trials
By Esha Senchaudhuri
With thanks also to Jitendarreddy Seelam and Ramanatha Saralaya for their input.
The fact of the matter is that I now want to recall everything, every trifle, every little detail. I still want to collect my thoughts and - I can't, and now there are these little details, these little details...” ― Fyodor Dostoyevsky, The Meek One
Old Fyodor was hardly talking about...
Read More
Topics:
clinical trials,
Clinical Development Strategy,
Early Phase Trials,
pharmacology
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...
Read More
Topics:
clinical trials,
Clinical Research Services,
Clinical Development Strategy,
outsourcing
In this blog, Paul Fardy, Executive Director of Data Management at Cytel shares his thoughts on how the data manager role has evolved.
Read More
Topics:
clinical data management,
big data,
Biometrics,
clinical trials,
real world evidence
Cytel data scientists apply advanced statistical techniques including predictive modelling of biological processes and drug interactions to unlock the potential of big data.
In this blog from our Career Perspectives series, we talk to Andrea Hita, at Data Scientist at Cytel, to find out more about her career path, her current role at Cytel and her interests outside of work.
Read More
Topics:
careers,
clinical research,
CRO,
Recruitment,
clinical trials,
Trial Design,
data science,
adaptive designs,
genetic algorithm,
model-informed-drug-development,
R language
Cytel has industry-leading experts in Statistical Programming, our programmers have years of SAS® Programming expertise, combined with in-depth knowledge of the specific clinical subject matter, which allows for competent and on-time completion of tasks.
In this blog, we talk to Omar, who is based in Geneva to find out more about his career path, current role at Cytel and his interests outside...
Read More
Topics:
Statistical Analysis,
careers,
clinical research,
Statistical Programming,
CRO,
Recruitment,
clinical trials,
CDISC,
Phase 3,
Trial Design
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...
Read More
Topics:
big data,
EDC,
data manager,
Clinical Data,
database build,
Clinical Research Services,
Data Management,
Oncology,
clinical trials