Strategic Clinical Data Management for Confident Drug Development
The patient data collected during a clinical trial is your enduring asset. Imagine if it fails — timelines slip, costs skyrocket, and patient access is delayed. Protect it from the start by partnering with Cytel to ensure your trial data is clean, compliant, and submission-ready — the first time.
Don’t Let Data Be Your Downfall
Cytel’s data management team understands what is at stake — every missed query, coding error, or integration gap can delay approvals and put your trial at risk. With an average of 12 years of experience — many having worked on the sponsor side — our experts are skilled at anticipating issues before they arise.
We do more than manage data — we build confidence. From the outset, we collaborate closely with sponsors, clinical operations teams, biostatisticians, and programmers to design data systems that hold up to global regulatory scrutiny and meet the highest standards of scientific rigor.
What’s at risk, without Cytel:
- Missed or late database locks > trial delays, missed milestones
- Sloppy SAE reconciliation > regulatory red flags
- Unstandardized coding > rejected submissions
- Fragmented systems > lost data, compliance gaps
Assured Data Integrity & Quality
Leverage advanced data cleaning techniques to prevent errors, ensuring reliable results for confident decision-making.
Expertise across therapeutic areas
Deep knowledge in diverse therapeutic areas including oncology and rare diseases, leveraging real-world evidence to enhance the quality of your clinical trials.
Seamless Collaboration & Accountability
Assured continuity across your drug development program with dedicated leadership, active collaboration, and responsive support for efficient project execution.
Optimized Site & Timeline Management
Proactive CRA and site support, along with strategic timeline alignment, ensuring smooth trial execution and timely study completion.
Fast, Compliant, Submission-Ready Data
Your submission is only as strong as your data. Cytel’s data management solution helps you navigate the complexities of drug development with confidence. From managing diverse data sources and formats to ensuring compliance with global regulatory requirements, we uphold the highest standards of data accuracy and integrity.
Timely database locks are critical to meeting study timelines and require rigorous data validation to ensure completeness and compliance. Our approach integrates real-time data monitoring and advanced analytics for data consistency and reliability. With a strong focus on precision and a deep understanding of regulatory nuances, we streamline workflows, improve data quality, and facilitate smoother regulatory submissions. Because when your data is defensible, your drug gets to approval faster.
End-to-End Clinical Data Management Solutions
From startup to closeout, our lead data managers oversee every stage of your study, ensuring seamless data capture, integration across multiple sources, and the highest standards of accuracy and reliability. Our structured approach includes:
- Customized Database Design – Tailored to efficiently capture data from diverse sources.
- Rigorous Data Validation & Standardized Coding – Ensures accuracy, consistency, and regulatory compliance.
- SAE Reconciliation & Third-Party Data Integration – Aligns safety data across sources and incorporates external data for a complete, high-quality dataset.
- Quality Audits & Security Measures – Maintains data integrity with regular audits and robust security protocols.
- Final Data Analysis – Ensures clean, validated data for confident decision-making and regulatory submissions.
Don’t Let Audit Trails Derail You
Regulators are watching — and they expect you to do the same. Cytel’s Audit Detective solution, aligned with the 2023 guidance, is designed to streamline and enhance audit trail reviews.
Audit Detective offers review support across a wide range of clinical data sources, ensuring transparency and compliance. In addition to clinical data, it is also applicable for reviewing audit trails in key systems such as the electronic Trial Master File (eTMF), Clinical Trial Management System (CTMS), and Learning Management System (LMS), providing a comprehensive solution for tracking and maintaining data integrity across critical trial processes.
Discover Audit DetectiveReal Risk Detection, Not Just Monitoring
Traditional on-site monitoring and 100% SDV account for up to 30% of clinical trial costs, yet they are not designed to detect statistical anomalies within or across patients, sites, or studies. Central statistical monitoring (CSM) — a key component of risk-based quality management — offers a proactive approach to detect emerging risks to data quality, safety, and trial conduct, enabling study teams to intervene early and address any confirmed issues and mitigate emerging risks.
Cytel’s Cytelytics tool delivers central statistical monitoring that actually analyzes your data for anomalies and risks, across patients, sites, and systems. With early warnings and actionable insights, you will reduce errors, prevent protocol deviations, and improve patient safety — all while optimizing costs and oversight.
Discover Cytelitics
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50+
NPS 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
Frequently Asked Questions (FAQs)
What is clinical data management?
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?
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?
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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