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Data Management

Our global team of Data Management Project Leaders, Data Managers, Programmers, and Medical Coders possesses expertise in data collection, validation, and the programming of SAS clinical trial databases. Our team’s expertise extends to centralizing trial study data from various sources, including EDC (Electronic Data Capture), PK (Pharmacokinetic), Central Labs, PD (Pharmacodynamics), and Imaging.

Throughout the study project lifecycle, our Data Management team meticulously reconciles and cleanses data to ensure its accuracy and completeness. We foster transparency and accessibility for trial oversight from the sponsor by providing them with tailored services, dashboards, and tools. These tools empower sponsors to gain comprehensive insights into operational oversight and access critical data deliverables, such as safety data listings and patient profiles.

Our clinical data management services will encompass the entire spectrum of clinical trials, from study design and protocol development to quality data collection, entry, review, validation, coding, and reporting. We utilize cutting-edge technologies and industry-standard practices to ensure the highest quality of data, adhering to stringent regulatory standards and global data management guidelines.

CDISC SDTM

As a CRO, we’ve been providing CDISC SDTM deliverables to sponsors since 2010, ensuring that your clinical trial data is securely managed and compliant with global standards. Our commitment to CDISC SDTM compliance is unwavering, reflected in our dedicated governance group that actively participates in CDISC workshops, maintains rigorous processes and tools, and continuously trains our team.

Our CDISC SDTM database expertise extends beyond our internal standards. We seamlessly collaborate with sponsors and medical groups who have their own CDISC implementation, ensuring a seamless transition of data from various sources. We offer a comprehensive suite of CDISC SDTM deliverables, including:

SDTM Datasets: We generate standardized SDTM solutions that will comply with the latest CDISC guidelines, ensuring data quality, consistency, and accessibility.
Define.xml and Reviewer’s Guide: We provide comprehensive Define.xml files and Reviewer’s Guides, providing detailed documentation on the data structure and facilitating seamless data review and validation.
SEND Package for Preclinical Projects: For preclinical studies, we create comprehensive SEND packages that will encapsulate all relevant preclinical data in an organized manner.

OUR TEAM

At the heart of Biotrial’s clinical trial data management services lies a team of highly skilled professionals, each contributing their unique expertise to ensure the seamless operation of each project.

DM Project Leaders

Assuming the role of project captain, guiding the entire data management process from inception to completion. They oversee all document preparation, and programming tasks, and ensure alignment with regulatory requirements.

SAS Programmers

The architects of our data management systems meticulously program the SDTM database and generate comprehensive deliverables such as patient profiles, data listings, and define.xml files. Their expertise lies in translating clinical data into a standardized format, facilitating seamless analysis and reporting.

SDTM Experts

The guardian of CDISC SDTM compliance, overseeing all SDTM database-related activities, including regulatory monitoring, training team members, interacting with sponsor counterparts, and maintaining Biotrial’s SDTM tools. They will ensure that our data management practices adhere to the highest international standards.

Data Managers

The backbone of our team, providing invaluable support to DM Project Leaders throughout the entire project lifecycle. They skillfully handle high-quality data collection, entry, review, validation, coding, and reporting, ensuring the accuracy and integrity of clinical trial study data each time.

Related Information

EDC Biostatistics Medical Writing Preclinical Clinical Core Lab Bionanalysis