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Clinical Data Management Services

Streamline your clinical trials with Cytel’s expert clinical data management to ensure data quality, integrity and traceability.

Comprehensive Clinical Data Management Services

We offer extensive data management solutions for all phases of your clinical studies, integrating our expertise in statistics. Our services span Phase I to Phase IV trials and employ both Functional Service Provider (FSP) and Project Based Solution (PBS) models. Our lead data manager will work with you from startup to closeout, staying closely involved in data capture and integration across multiple sources. Our experts collaborate closely with your team to design databases that are both robust and user-friendly, ensuring that every project is delivered on time, with high-quality data tailored to meet your specific study needs

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Proactive data cleaning

Implementing advanced techniques in data cleaning prevents errors and enhances your data integrity for reliable results.

Expertise across therapeutic areas

Our data managers bring specialized knowledge in diverse fields such as oncology and rare diseases, including using real-world evidence, to enhance the quality of your clinical trials.

Global reach with local expertise

Leverage Cytel’s global data management solutions to deliver compliance with international and local regulatory standards.

Expert data management with remote trial experience

Benefit from our extensive experience in remote trials and innovative study designs, ensuring streamlined data management.

Navigate Clinical Data Management Challenges in Drug Development

Cytel’s effective clinical data management helps you meet the challenges of drug development with confidence, from navigating complex regulatory environments across different countries to maintaining high standards of data accuracy and integrity. This includes managing the intricacies of data collection, which often involves a variety of data sources and formats. Timely database locks are critical to meeting your study timelines and require rigorous data validation processes to ensure completeness and compliance. Our approach incorporates real-time data monitoring systems and advanced analytics to ensure data consistency and reliability. With a focus on precision and a deep understanding of regulatory nuances, we enhance your data quality and streamline workflows to mitigate risks and pave the way for successful trial outcomes. Our comprehensive management ensures that your data meets regulatory and scientific standards, facilitating smoother regulatory submissions and faster drug approvals.

End-to-End Clinical Data Management Solutions

Cytel’s comprehensive clinical data management services span the entire clinical trial lifecycle, ensuring you achieve precision from setup to closeout. Our process begins with customized database design for efficient data capture from diverse sources. Rigorous data validation and standardized coding ensure accuracy and compliance, while serious adverse event reconciliation and third-party data integration enhance dataset quality. Regular quality audits, stringent security measures, and final data analysis are integral to our approach. By maintaining high standards throughout, we deliver reliable results for every phase of your clinical studies, hence accelerating drug approvals.

Data Strategy eBook

Discover the Value of an Optimized Clinical Data Strategy in our eBook.

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69

2024 Net Promoter Score, reflecting outstanding client satisfaction.

12

Average years of experience of our global data management team

90%

Of Cytel projects involve a clinical CRO

40

Annual client audits and annual client agency inspections

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Claim your free 30-minute strategy session

Book a free, no-obligation strategy session with a Cytel expert to get advice on how to improve your drug's probability of success and plot a clearer route to market.

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Frequently Asked Questions (FAQs)

What is clinical data management?
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Clinical data management (CDM) refers to the process of collecting, cleaning, and managing data generated during clinical trials or research studies to ensure its accuracy, consistency, and reliability. It plays a critical role in transforming raw data collected from diverse sources into high-quality datasets that are suitable for statistical analysis, regulatory submission, and evidence generation. A key objective of CDM is to ensure that data meets the regulatory requirements thereby supporting informed decision-making and the successful development and approval of new treatments or interventions.

What work is done within clinical data management?
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Clinical data management involves a wide range of tasks throughout a clinical trial to ensure that data is high-quality, accurate, and ready for analysis. Broadly, this includes tasks related to study set-up and planning, data collection and entry, data cleaning and validation, database design and lock, and various other ongoing and supporting tasks.

What are the three phases of clinical data management?
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Clinical data management consists of three main phases: study set-up, study conduct, and study closeout. Study set-up involves preparing all systems, documents, and process needed for data collection and management. Study conduct involves collecting data from the clinical trial, followed by validation and cleaning. Lastly, in the study closeout phase, the database is cleaned, locked, and prepared for statistical analysis, regulatory submission, and archiving.

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