Services Brochure 2016

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Services The Largest Global Biometrics CRO Quality First Premier biometric services from a team as dedicated as you are. Our Approach: As the world’s leading biometrics CRO, all of Cytel’s processes, talent and expertise are applied to maximizing the value of clinical data. A standardized approach to data collection and analysis ensures traceability and delivers operational efficiencies. Our specialist knowledge helps our customers to lower clinical trial risks, accelerate development and improve the probability of success. Whether you’re a global pharmaceutical company or a virtual biotech, Cytel will provide a dedicated project team with the experience to ensure that work is done accurately, on-time and on-budget. Every customer deserves the A-team. Our Promise: "The Cytel team understood Quality comes first and our objective is to get it right- first time. Our precisely what we needed, and operational staff have an average of 15 years’ experience each, delivered quality work within a ensuring minimal oversight and seamless project delivery. A low very demanding timeframe. staff turnover assures personnel continuity and retention of knowledge for your project. They did it right the first time. As a result, we provided the FDA-requested safety reports without impacting our development timelines." 500+ 20+ Sylvain Nicolas, Global Head Biostatistics, Phase 1 Studies Phase I-IV FDA/EMA Sanofi Trials Approvals Strategic Consulting Experience, Expertise and Innovation • Efficient Drug Development • Adaptive Design and Implementation Services • Program and Portfolio Optimization • Strategic Regulatory Advice • DMC and Interim Analysis Support Broad Range of Therapeutic Expertise Data Management Clean, Reliable Data – Faster • CRF/eCRF Design, Annotation and Database Build • Edit Check Specifications and Data Management Plan • Query Management and Medical Coding • Serious Adverse Events (SAE) Reconciliation • Lab Reconciliation 25% Other 15% Cardiology Quantitative Pharmacometrics and Pharmacology 20% Oncology 10% Gastroenterology Critical Decision-Making 20% 10% Endocrinology / Neurology Metabolism • Non-Compartmental PK Analyses • Population PK Modeling • Exposure-Response Analysis • Comparator Databases • Model-based Meta-Analysis Statistics & Programming Knowledgeable and Efficient Execution Medical Writing • SAP Development Accurate Report Writing • Protocol Development • Clinical Protocols • Charter Development • Clinical Study Reports • Statistical Analysis • PK/PD Analysis Reports • PK/PD Analysis • Development Safety Update Reports and IB Updates • Statistical Reports • Submission Documents (ISS, ISE) • Programming TLFs • Abstracts and Manuscripts • Analysis Dataset Development • Randomization • Independent Statistical Center Support CDISC Services • Data Monitoring Committee Support Reliable and Compliant Standardization • Data Transfer, QC and Lock • Data Anonymization Services • Data Standards Governance • CRF Annotation • SDTM Dataset Development • ADaM Dataset Development • Reviewer’s Guide • OpenCDISC Compliance Checking We work around the clock Cambridge Geneva Pune Cytel: The Industry’s Largest Biometrics CRO NDA Submissions: 15+ Cytel is committed to improving the quality, analysis and interpretation of data for clinical development. Founded by world-renowned biostatisti- cians and Fellows of the American Statistical Asso- ciation, Cytel maintains a tradition of leadership Scientific Publications: in statistical innovation. Our team is dedicated to improving the probability of clinical trial success 550+ and helping to deliver new medicines to the patients who need them. Scientific Conferences: Learn more about how we can 1100+ work together [email protected] www.cytel.com .

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ACES – a Cytel White Paper
ACES – A Cytel White Paper Eric J. Silva May 2012 Abstract In the past decade, there has been a significant increase in the use of Data Monitoring Committees (DMC) and Adaptive Designs (AD) in clinical trials. While the monitoring of safety data by a formal committee is not required for all clinical trials, it has become the norm to have a formal DMC conduct periodic safety reviews for any controlled trial that evaluates treatments intended to prolong life or reduce risk of major adverse health outcomes, or for trials that compare rates of mortality or major morbidity. Confirmatory, pivotal, and adaptive design trials have more complex operational issues requiring an external and independent DMC. The DMC may have access to unblinded interim data, be required to make expert recommendations about how the trial should continue, and then ensure that planned adaptations are implemented as outlined in the protocol without involving the sponsor or exposing it to unblinded data or results. This added complexity creates a challenge and a question: how can the DMC, statisticians, and sponsor effectively communicate, share blinded and unblinded data, perform analyses, and implement adaptations without introducing operational bias or compromising the integrity of the trial? One solution is to utilize a sophisticated computer system that can provide the security and necessary firewalls to ensure that interim data is only accessible to those it is intended for, that the rules and processes outlined in the protocol and DMC charter are enforced, and that communication between the DMC and sponsor is effectively facilitated while protecting the integrity of the trial and preventing the introduction of operational bias.
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Cytel Software Development
Shaping the Future of Drug Development Cytel Software Development EUGM November 2019 Agenda ❖ Company Update ❖ Software Update ❖ East On-Demand and the Future of East Cytel Inc. 2 The Data Revolution is Here Increased complexity, volume and the proliferation of data sources requires advanced analytics and insights to harness its power Increased Complexity, Volume And We are purpose built to The Proliferation Of Data Sources address this challenge as the pioneering experts in analytical solutions for clinical development Advanced Analytics And Insights 30+ year track record of exponential growth underpinned by quality Power To Transform Healthcare 20+ 100% Our People Are Recognized More Adaptive> Trial Acceptance Leaders With Instrumental Scrip Award Designs Than Any Other Data Sets By FDA Roles In Industry Think-tanks Best Specialist CRO And Associations Organization Consulting Services Real World Define the Execute against Analytics Authored The Seminal Piece on Adaptive Years Of Leadership problem the problem Bring novel data Of Advanced Designs Featured In New Analytics assets to bear England Journal of Medicine Software Leverage Technology FDA 600+ Software Used By Publications The FDA To Review Industry Designs Top 30 900+ <10% Of The Best And Top 30 Pharma Low Employee Brightest Talent In Companies Use Our Turnover Our Sector Services And Technology 11/12/2019 Cytel Inc. 4 Driving the New Paradigm Leverage Historical Apply Fast Flexible Optimize Go/No-go Centralize Efficient And Real-world Trial Designs Decision Making Data Collection
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Services Brochure
The Technology CRO Technology Is The Diﬀerence Cytel Clinical Research Services combines decades of biostatistical advancements, clinical software programming, operations know- Clinical how and deep regulatory familiarity. Technology Platform Cytel focuses on developing and deploying technology solutions that empower sponsor companies to substantially improve their clinical process eciencies and outcomes. Software Tools CRO Services Trial Design Strategy Built upon collaborations with industry and regulators, Cytel trial Data Analysis Biostatistics design, analysis and data management software are relied on for their precision and proven ability to speed critical processes. Process Automation Data Management Comprehensive Clinical Operations Trial Management Programming Medical Writing Statistics & Data Management Programming Medical Writing CDISC • CRF development & annotation • Trial design & simulation • Protocol preparation • CRF annotation • Data management plan • FDA/EMA representation • Clinical study report writing • SDTM data set development • Database development • Sample size calculation • Submission documents • ADaM data set generation • CRF tracking • Protocol development • ISS and ISE writing • Define XML creation • Validation checks • Randomization - Adaptive & Traditional • Abstracts and manuscripts • WebSDM® compliance checking • Edit checks and query generation • Recruitment forecasting • Investigator brochures • Coding AE and medications • Event monitoring • Integrate lab data • Independent Statistical • Reconcile AE and SAE Center support See Case Studies and • Data cleaning & validation • DMC/DSMB organization Get More Information at • Lock database • Statistical Analysis Plan • Data set transfer • Statistical programming www.cytel.com Headquarters: Cambridge, MA + 1.617.661.2011 Oﬃces: Philadelphia, PA +1.610.994.9830 San Jose, CA +1.857.928.6230 Paris, FRANCE +33.1.40.331.776 Pune, INDIA +91.98509.70522 Cytel Clinical Research Services are trusted by drug, biologic and medical device developers worldwide.
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The Largest Global Biometrics CRO Strategic Consulting Experience Expertise Innovation
We work around the clock Services Cambridge Geneva Pune Cytel: The Industry’s Largest Biometrics CRO Shaping the future of drug development means scaling efficient and responsible clini- cal practice using the best quality data. As the industry’s largest biometrics CRO and leading provider of advanced clinical trial software, Cytel is committed to improving the quality, analysis and interpretation of data for clinical development. Founded by world-renowned biostatisticians and Fellows of the American Statistical Association, Cytel maintains a tradition of leadership in statistical innovation by bringing together individuals passionate about modernizing the financial and methodological practic- es of clinical development. Placing quality at the center of its promise, Cytel guaran- tees efficient delivery and the highest standards. Learn more about how we can work together [email protected] The Largest Global Biometrics CRO www.cytel.com Strategic Consulting Experience Expertise Innovation • Efficient drug development • Adaptive design and implementation Services • Program and portfolio optimization • Strategic regulatory advice • DMC and Interim Analysis Support Broad Range of Therapeutic Expertise Data Management Producing Cleaner, More Reliable Data – Faster • CRF design, annotation and database build • Edit check specs and DMP • Query management and medical coding • Serious Adverse Events (SAE) Reconciliation Quality First • Lab Reconciliation • Data Transfer, QC and lock Premier biometric services from a team as dedicated as you are.
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Creators of Pioneering Software and Clinical Services Company Look Back and to the Future
Cyrus Mehta (left) and Nitin Patel (right) at Cytel’s 25th anniversary banquet. Creators of Pioneering Software and Clinical Services Company Look Back and to the Future CHANCE magazine invited Cyrus Mehta and Nitin Patel of Cytel, Inc. to talk with Scott Evans, executive editor of CHANCE. Cytel is a pioneer in the development of software for exact methods, clinical trial design including adaptive designs, and statistical consulting and services. Mehta and Patel discuss their background, the challenges of developing and maintaining Cytel, and what they have learned on their journey. Evans: Please tell me about your backgrounds and I was still a student in India, we really became friends how you met. at MIT. I’ve learned a lot from him both about how to conduct original research and about how to live well. Mehta: We are both from Bombay, India, and went to high school and undergraduate college in Bombay, Patel: I obtained my bachelor’s degree in Electrical followed by graduate studies at MIT. I got my bach- Engineering at the Victoria Jubilee Technical Institute elor’s degree in Civil Engineering at the Indian Insti- (VJTI) of Bombay University. VJTI was set up in 1887 tute of Technology, Bombay, and my master’s and PhD to celebrate Queen Victoria’s Golden Jubilee and is in Operations Research at MIT. I learned statistics on one of the oldest engineering colleges in India. On the job. Although I had met Nitin once or twice when graduation, I joined MIT, which incidentally was CHANCE 51 Ahmedabad, or IIMA, as it’s popularly known in Cyrus Mehta is co-founder and president of Cytel Inc.
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INDSTATS 2019 Innovations in Data and Statistical Sciences Co-Organizer: IIT Bombay, Mumbai, India Updated December 12, 2019
Scientific Program: INDSTATS 2019 Innovations in Data and Statistical Sciences Co-organizer: IIT Bombay, Mumbai, India Updated December 12, 2019 December 26th - 30th, 2019 Venue: Victor Menezes Convention Centre, Location on Map: Click here! Layout Plans: Ground Floor, First Floor Thursday, Dec 26, 2019 9:00am - 1:00pm Parallel Workshops 1. Surviving the Big Data challenge - Why Data Science needs Statisticians for making AI Effective Course Facilitator: Professor Arnab Kumar Laha , Indian Institute of Management Ahmedabad Venue: Seminar Room 1 2. Statistical Methods for Geospatial Analysis Course Facilitator: Dr. Pradeep Mohan, SAS Institute Venue: Seminar Room 2 9:00am - 5:30pm R Conference 1. R Conference Invited Speakers: (a) Susan Holmes, Professor of Statistics, Stanford University (b) Martin Morgan, Research Professor, Biostatistics, SUNY, Buffalo and Director of the Bioconductor project Venue: Lecture Hall 21 Friday, Dec 27, 2019 9:30am - 10:30am Plenary Session 1. R R Bahadur Memorial Lecture Organizer: Hira L. Koul, Michigan State University Chair: Hira L. Koul, Michigan State University Venue: Main Auditorium Asymptotics of large dimensional random matrices and its uses in statistical analysis, Arup Bose, Indian Statistical Institute, Kolkata 10:35 - 11:55am Special Invited Session 1. Special Invited Session 1 Chair: Mahesh Iyer, Sineflex Solutions LLP Venue: Main Auditorium (a) Specifying scale in null hypotheses for noninferiority clinical trials, Richard J. Chappell, University of Wisconsin-Madison (b) Small area prediction
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13Th ANNUAL CONFERENCE Track IV – Biostatistics and Statistical Programming 24Th – 25Th January 2020
Indian Society for Clinical Research 13th ANNUAL CONFERENCE Track IV – Biostatistics and Statistical programming 24th – 25th January 2020 Speaker Profiles Session #1 Statistics in Study Design Overview of Adaptive Designs and Regulatory Perspective Pinakin R. Jani, Associate Director, Biostatistics, IQVIA Pinakin Jani is a biostatistician in healthcare and has nearly 14 years of industry experience. He has worked in pharma companies, CROs and BPO setups in health care, he has worked for several top pharmaceutical sponsors. Currently, he is working as Associate Director at IQVIA, located in Ahmedabad and he works with IQVIA Biostatistics and Programming team. He is responsible for handling FSP accounts operations, project management, oversight for India region and works as a subject matter expert. His interest includes reading, teaching and travelling. Drilling Down the Design Dilemma – A Story of Choosing the Right Design for Phase II Oncology Trial Dr. Parasar Pal, Associate Director, Early Development Biostatistics (EDB), Novartis Dr. Parasar Pal has obtained Doctor of Philosophy from University of Kalyani, West Bengal in Business Administration. Prior to that he completed Masters in Statistics from University of Calcutta. He has more than fourteen years of experience in providing statistical support to various early development clinical trials including Proof of Concept and Pharmacodynamics. He provided project level statistical support to some key products during submission. He also worked in late phase clinical trial and provided statistical support in one of the Neuroscience projects. Currently working with Novartis as a Group Head in Early Development Biostatistics and leading a group of statisticians working in early development projects in General Medicine and Oncology in India and Basel (Switzerland).
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Cytel Launches East® Version 6.3 for Adaptive Dose-Escalation Studies and Accurate Interim Trial Prediction
Cytel Launches East® version 6.3 for Adaptive Dose-Escalation Studies and Accurate Interim Trial Prediction Game-changing new features in dose-escalation designs, gatekeeping procedures for multiple endpoints, and trial prediction tools, continue East® software’s twenty year tradition of reliable innovation. Cambridge, MA, July 15, 2014 – Cytel Inc., the industry’s leading provider of adaptive trial design software, consultancy and clinical research services, announced today the release of East® version 6.3. East® 6.3 addresses both emerging and persisting challenges in clinical trial design including accurate prediction of the future course of a study based on accumulating data, advanced tools for multiplicity adjustment (including parallel and serial gatekeeping procedures), and modern dose-escalation methods to accurately estimate a therapeutic’s maximum tolerated dose (MTD). “As East® marks two decades of helping medical drug and device developers design and implement adaptive clinical trials, we continue to listen to our users’ needs and deliver powerful, valuable tools to serve sponsors in planning and optimizing their clinical development options. We greatly appreciate our user community’s extended support in helping us provide validated statistical software like East® and StatXact® that meet the needs of industry, academic, and regulatory organizations, including the U.S. Food and Drug Administration, the European Medicines Agency, and Japan’s Pharmaceuticals and Medical Devices Agency,” said Yannis Jemiai, Vice President of Software and Consulting at Cytel Inc. This latest release of East® introduces several new modules, including: East® ESCALATE offers design, simulation and monitoring capabilities for some of the latest model-based dose-escalation designs. These include popular Bayesian methods such as the modified Toxicity Probability Intervals, first advocated by prominent M.D.
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In Collaboration With
in collaboration with London, 29 March 2010 Doc Ref. EMA/779520/2009 EMA/EFPIA 2nd WORKSHOP Adaptive Design in Confirmatory Trials 2nd April 2009, European Medicines Agency, Canary Wharf, London Abstract In April 2009 the EMA/EFPIA held their 2nd workshop on adaptive designs. The objective was to illustrate the application of “Good Adaptive Practices” through presentations and discussions of case studies. The focus was on adaptive designs in confirmatory trials, including seamless adaptive Phase II/III trials. The Workshop was co-chaired by Prof. Bruno Flamion, Chair of the CHMP Scientific Advice Working Party (SAWP) and Dr. Solange Corriol- Rohou, Chair of the EFPIA efficacy ad-hoc group. The workshop was well attended (150 attendees) and there was a good level of informal dialogue between a wide range of experts including representatives from Regulatory Authorities (Europe and the US), Academia, Industry, and external organizations. Executive summary On April 2, 2009, EFPIA/EMA held their 2nd workshop on Adaptive Designs in Confirmatory Clinical Trials. The 1st workshop in December 20071 had provided an opportunity to introduce and discuss the EMA’s “Reflection Paper on Methodological Issues in Confirmatory Trials Planned with an Adaptive Design”2. Key outcomes and open questions were summarized by Prof. Bruno Flamion while Dr Solange Corriol-Rohou (AZ) briefly presented the expectations of the joint workshop: - Cost of R&D is a public health issue. There is growing patient pressure for early access to new drugs: interim analyses can be ethical or even mandatory. However, the cost of R&D and time savings per se cannot be the main rationale for using adaptive designs (AD).
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JN1498 Scrip Awards 2018 Preview Ad 19-10 A.Indd 1 2018/10/12 14:24
Scrip Awards Finalists 2018 www.scripawards.com Best Contract Research Best Contract Research Organization – Full-Service Providers Organization – Specialist Providers The Scrip Awards for Best Contract Research The Scrip Awards for Best Contract Research Organization acknowledge the critical role that CROs Organization acknowledge the critical role that play in drug development. This Award is for those CROs play in drug development. This Award is for companies who provide the full range of services to those companies who provide specialist services their clients. to their clients. CMIC Group Cytel Japan’s first CRO, CMIC Group, is now involved in nearly 80% of new Cytel helps its customers to improve decision-making and reduce drug development and filings in its home market. Over the last 25 risk across the drug product lifecycle. It increases R&D productivity years, it has grown to offer the full range of services encompassing through a combination of clinical trial software solutions, strategic the entire pharma value chain, including drug development and consulting, and clinical research services. It has demonstrated its core manufacturing, clinical research and operational support, clinical site expertise in trial design and planning as well as expertise in helping management, and sales and marketing. sponsors optimize their programs. Covance Illingworth Research Group Covance has broadened its solutions for customers with a series of This niche CRO specializes in the provision of medical photography investments and new offerings. Its acquisition of Chiltern strengthened and mobile research nurses to allow patients to receive some of their its clinical development offering and added new expertise in medical clinical trial procedures away from the site – usually in their own devices, as well as creating leading oncology expertise.
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ACES® – a Cytel White Paper
ACES® – A Cytel White Paper Eric J. Silva May 2012 Abstract In the past decade, there has been a significant increase in the use of Data Monitoring Committees (DMC) and Adaptive Designs (AD) in clinical trials. While the monitoring of safety data by a formal committee is not required for all clinical trials, it has become the norm to have a formal DMC conduct periodic safety reviews for any controlled trial that evaluates treatments intended to prolong life or reduce risk of major adverse health outcomes, or for trials that compare rates of mortality or major morbidity. Confirmatory, pivotal, and adaptive design trials have more complex operational issues requiring an external and independent DMC. The DMC may have access to unblinded interim data, be required to make expert recommendations about how the trial should continue, and then ensure that planned adaptations are implemented as outlined in the protocol without involving the sponsor or exposing it to unblinded data or results. This added complexity creates a challenge and a question: how can the DMC, statisticians, and sponsor effectively communicate, share blinded and unblinded data, perform analyses, and implement adaptations without introducing operational bias or compromising the integrity of the trial? One solution is to utilize a sophisticated computer system that can provide the security and necessary firewalls to ensure that interim data is only accessible to those it is intended for, that the rules and processes outlined in the protocol and DMC charter are enforced, and that communication between the DMC and sponsor is effectively facilitated while protecting the integrity of the trial and preventing the introduction of operational bias.
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The Prevention and Treatment of Missing Data in Clinical Trials
This PDF is available from The National Academies Press at http://www.nap.edu/catalog.php?record_id=12955 The Prevention and Treatment of Missing Data in Clinical Trials ISBN Panel on Handling Missing Data in Clinical Trials; National Research 978-0-309-15814-5 Council 162 pages 6 x 9 PAPERBACK (2010) Visit the National Academies Press online and register for... Instant access to free PDF downloads of titles from the NATIONAL ACADEMY OF SCIENCES NATIONAL ACADEMY OF ENGINEERING INSTITUTE OF MEDICINE NATIONAL RESEARCH COUNCIL 10% off print titles Custom notification of new releases in your field of interest Special offers and discounts Distribution, posting, or copying of this PDF is strictly prohibited without written permission of the National Academies Press. Unless otherwise indicated, all materials in this PDF are copyrighted by the National Academy of Sciences. Request reprint permission for this book Copyright © National Academy of Sciences. All rights reserved. The Prevention and Treatment of Missing Data in Clinical Trials Panel on Handling Missing Data in Clinical Trials Committee on National Statistics Division of Behavioral and Social Sciences and Education Copyright © National Academy of Sciences. All rights reserved. The Prevention and Treatment of Missing Data in Clinical Trials THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Govern- ing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineer- ing, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropri- ate balance.
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