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 develop- ment 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, anal- ysis and interpretation of data for clinical devel- opment. 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
www.cytel.com