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.
Jul 27, 2018 7:53:00 AM
Jun 19, 2018 9:30:00 AM
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...
Apr 25, 2018 10:13:00 AM
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...
Mar 14, 2018 11:31:00 AM
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...
Nov 22, 2017 8:46:00 AM
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.
Nov 15, 2017 8:46:00 AM
Each year Halloran Consulting Group hosts‘CORE’ (Clinical Operations Retreat for Executives) as a forum for industry executives to discuss pressing challenges in a collaborative environment. This year, our Senior V.P. of Clinical Research Services, Irving Dark, discussed the topic of vendor qualification and posed the question to the group: are there better alternatives to the traditional...
Nov 2, 2017 9:05:00 AM
Last month was the eighth American Conference on Pharmacometrics (ACoP8) in Florida, a key event on the calendar for Cytel’s Quantitative Pharmacology and Pharmacometrics subject matter experts.
Cytel was delighted to contribute to the event this year and present two posters. This was excellent opportunity to share our knowledge and innovative research, alongside networking with likeminded...
Oct 24, 2017 6:01:00 AM
The ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop is sponsored by the ASA Biopharmaceutical Section in cooperation with the FDA Statistical Association. Each year 800 statistical practitioners come together to absorb new information on statistical practices in all areas regulated by the FDA.
Cytel was honored to be involved in the workshop program, and our subject...
Oct 4, 2017 7:34:36 AM
The Society for Clinical Data Management (SCDM) conference landed in Orlando last week providing insights and key trends for clinical data managers from around the world. In this blog we share an infographic of some of the agenda highlights along with a more detailed overview of our Alla Muchnik's contribution to the session Study Medication Compliance: Data Collection Challenges.
Sep 29, 2017 3:01:00 PM
Namrata Deshpande, Senior Team Lead will be participating in a round table discussion at the Women in Statistics event in California, October 19-21.
This is the first blog in a new 'Career Perspectives' series and we talk to Namrata to find out more on her career path, achievements, current role at Cytel and her interests outside of work.
Topics: biostatistics, Clinical Research Services, Clinical Development Strategy, Statistical Innovations in Clinical Development, Statistical Analysis, Statistical Programming, careers, East, R programming
Sep 13, 2017 9:00:00 AM
Antibiotic resistance is one of the greatest challenges facing human health today. We are excited to welcome Dr. Scott Evans of the Harvard T.H Chan School of Public Health (HSPH) to the blog to discuss how the novel statistical methods he is developing could help tackle this global crisis.
Sep 11, 2017 11:25:00 AM
At the East User Group meeting (EUGM) on 25th and 26th October, we will welcome a number of renowned industry speakers to discuss some of the most promising approaches in innovative trial design. Over the next few weeks, we will profile a number of the speakers and their talks. In this blog, we talk with Bob Beckman M.D in advance of his presentation ‘Design Concept for a Confirmatory Basket...
Aug 2, 2017 7:07:00 AM
As a biometrics -focused CRO, Cytel regularly works across a program of studies, providing data consistency, and helping to minimize the oversight burden for the sponsor. In this case study, we describe our work with a client on two Phase 1 studies, and how we were able to carry a number of important efficiencies from the first study to the second.
Jul 25, 2017 7:37:09 AM
The Joint Statistical Meetings (JSM) is the largest and arguably most highly respected gathering of statisticians in the world. It will bring together over 6000 statisticians and runs from Saturday, July 29, to Thursday, August 3, 2017. With over 600 sessions, it can be a challenge to identify the most crucial ones to attend. To help out, we've asked some of the Cytel team for their top...
Topics: biostatistics, Oncology, Clinical Research Services, Clinical Development Strategy, Adaptive Clinical Trials, Statistical Innovations in Clinical Development, Statistical Analysis, Statistical Programming
Jul 19, 2017 9:00:13 AM
With adaptive and innovative trial designs on the rise, operational implementation of interim analyses, including management of Independent Data Monitoring Committees is increasingly important. In this blog, we will share a case study of how Cytel provided a client with seamless Independent Data Monitoring Committee support encompassing committee selection and management, independent...
Jul 13, 2017 5:25:00 AM
By Tejasweeni Rajput
It’s been known for centuries that a picture can tell a thousand words. In an era of new technologies, and increasing volume of information, visualizations can help us to express complex data simply and effectively. Advanced technology is now available that allows statisticians and data scientists to drill down into the data sets to be analysed, and develop dynamic...
Jun 28, 2017 4:36:40 AM
About the Author: Manjusha Gode has over 28 years' IT experience spanning delivery Management, quality management, software testing, people management, process improvement and multi-locational operations. She is a pioneering member of Cytel's clinical programming team.
Clinical data transparency improves decisions for all healthcare stakeholders including patients, caregivers, healthcare...
Jun 20, 2017 7:17:47 AM
At ASCO 2017, Cytel trial design experts joined our medical and academic colleagues to share the most recent innovations in cancer research.In this blog we will share the abstract and pdf of the poster presentation: TAPPAS: Adaptive enrichment phase 3 trial of TRC105 and pazopanib versus pazopanib alone in patients with advanced angiosarcoma (AAS), co-authored by Cytel's Cyrus Mehta and...
Mar 20, 2017 9:54:00 AM
In the randomized clinical trial (RCT), the process of deciding the randomization method and implementing is critically important. Unfortunately, it is not unheard of for problems to arise. In an article (Downs et al 2010 1), it is noted that as well as initial errors of trial design, problems can arise from errors with programming of the randomization or even human error during the course of...
Mar 15, 2017 8:51:00 AM
A precise and thorough approach to planning is key for success in data management.
The Data Management Plan (DMP) is a critical document in any data management project. It outlines all of the data management work to be done, the timelines and milestones to be achieved, as well as the outputs to be produced. The DMP lets all of the stakeholders know what to expect, how to expect it and when...