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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. Statistics & Programming 25% Other 15% Cardiology A Team Custom Built for Your Needs Cytel’s dedicated team of professionals is here to help you address an array of challenges when conducting drug development. Are you wondering if an adaptive trial design would accelerate your clinical development plan? Do you have • SAP Development 20% Oncology 10% Gastroenterology legacy data that needs to be migrated to a compliant SDTM format? • Protocol Development 20% 10% Endocrinology / Whether you face a complex statistical issue or the need for knowledgeable collaborators to handle biometrics and trial • Charter Development Neurology Metabolism implementation, Cytel has skilled professionals available when you need them. Our offices are spread over 5 time zones so • Statistical Analysis we can be close to our customers and offer around the clock support. • PK/PD Analysis Our Approach: • Statistical Reports • Programming TLFs Cytel’s approach to resourcing is based on the simple premise that every customer deservers the “A” team. Whether you’re a global pharmaceutical company or a virtual biotech, Cytel will provide a team with the experience to ensure that work is • Analysis Dataset Development done accurately, on-time and on-budget. • Randomization We understand that the key to a successful project is the caliber of the project team. This means: shared objectives, clear • Independant Statistical Center Support "The Cytel team understood and transparent communication, and a commitment to timelines and budgets. precisely what we needed, Cytel’s Statistical team averages 18 years of industry experience and our Statistical Programming team averages 15 years. and delivered quality work We operate as an extension of your team with little to no supervision required on the part of the Sponsor. Medical Writing within a very demanding Accurate and Regulatory-Compliant Report Writing timeframe. Our Vision: • Clinical Protocols Cytel has a simple vision: to be the best biometrics CRO in the world. Everything we do, from the investments we make in • Clinical Study Reports They did it right the first time. infrastructure, the processes we define, and the people we hire, are all geared towards accomplishing this mission. • PK/PD Analysis Reports In our nearly 30 years, Cytel has pioneered the methodology and developed the software needed to design and implement As a result, we provided the adaptive trial designs. We earned a reputation for providing the highest quality products and services. • Development Safety Update Reports and IB Updates FDA-requested safety reports • Submission Documents (ISS, ISE) without impacting our devel- Centralized biometrics are a foundational feature of our aproach. Achieving high-quality data requires the project • Abstracts and Manuscripts Statistician and Clinical Data Managers to collaborate from start-to-lock. The Statistician’s focus on what’s important for opment timelines." analysis helps guide the Clinical Data Managers focus on areas that are critical to ensure data is clean and ready for analysis. This “risk-based” approach is key to ensure time is spent where it matters most. CDISC Migration Sylvain Nicolas, Global Head Biostatistics, Phase 1 Studies We sometimes hear from Sponsors a preference for a “one stop shop” CRO. Wouldn’t a more efficient approach be to Efficient Compliant Standardization Sanofi centralize biometrics activities with a CRO known for expertise? This “best in class” approach allows the Sponsor to select the • CRF Annotation best vendors based on their core competency. We will help you establish standards in data management, statistics and programming to be used across multiple studies. • SDTM Dataset Development • ADaM Dataset Development Our Promise: • Define-XML creation Our commitment to ‘Quality First’ includes uncompromising attention to streamlined workflows and predictable timelines, so • OpenCDISC compliance checking that every aspect of the project receives proper care and accountability. Our teams understand that there is no excuse for delay. Some of our team members have been working together for over a decade, thanks to low turnover rates, and have mastered the ability to deliver quality on the dot. 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. Statistics & Programming 25% Other 15% Cardiology A Team Custom Built for Your Needs Cytel’s dedicated team of professionals is here to help you address an array of challenges when conducting drug development. Are you wondering if an adaptive trial design would accelerate your clinical development plan? Do you have • SAP Development 20% Oncology 10% Gastroenterology legacy data that needs to be migrated to a compliant SDTM format? • Protocol Development 20% 10% Endocrinology / Whether you face a complex statistical issue or the need for knowledgeable collaborators to handle biometrics and trial • Charter Development Neurology Metabolism implementation, Cytel has skilled professionals available when you need them. Our offices are spread over 5 time zones so • Statistical Analysis we can be close to our customers and offer around the clock support. • PK/PD Analysis Our Approach: • Statistical Reports • Programming TLFs Cytel’s approach to resourcing is based on the simple premise that every customer deservers the “A” team. Whether you’re a global pharmaceutical company or a virtual biotech, Cytel will provide a team with the experience to ensure that work is • Analysis Dataset Development done accurately, on-time and on-budget. • Randomization We understand that the key to a successful project is the caliber of the project team. This means: shared objectives, clear • Independant Statistical Center Support "The Cytel team understood and transparent communication, and a commitment to timelines and budgets. precisely what we needed, Cytel’s Statistical team averages 18 years of industry experience and our Statistical Programming team averages 15 years. and delivered quality work We operate as an extension of your team with little to no supervision required on the part of the Sponsor. Medical Writing within a very demanding Accurate and Regulatory-Compliant Report Writing timeframe. Our Vision: • Clinical Protocols Cytel has a simple vision: to be the best biometrics CRO in the world. Everything we do, from the investments we make in • Clinical Study Reports They did it right the first time. infrastructure, the processes we define, and the people we hire, are all geared towards accomplishing this mission. • PK/PD Analysis Reports In our nearly 30 years, Cytel has pioneered the methodology and developed the software needed to design and implement As a result, we provided the adaptive trial designs. We earned a reputation for providing the highest quality products and services. • Development Safety Update Reports and IB Updates FDA-requested safety reports • Submission Documents (ISS, ISE) without impacting our devel- Centralized biometrics are a foundational feature of our aproach. Achieving high-quality data requires the project • Abstracts and Manuscripts Statistician and Clinical Data Managers to collaborate from start-to-lock. The Statistician’s focus on what’s important for opment timelines." analysis helps guide the Clinical Data Managers focus on areas that are critical to ensure data is clean and ready for analysis. This “risk-based” approach is key to ensure time is spent where it matters most. CDISC Migration Sylvain Nicolas, Global
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