Clinical Data Management

EMINENT offers comprehensive and tailored clinical data management solutions designed to meet the specific needs of each clinical trial. Our services are crafted to align seamlessly with individual protocol requirements, study site specifications, and client expectations. We specialize in developing customized data management plans that ensure effective and efficient handling of clinical trial data.

Our approach utilizes top-tier Electronic Data Capture (EDC) systems, carefully chosen to suit each project’s unique needs. We meticulously design Case Report Forms (CRFs) and provide detailed guidelines for CRF completion to facilitate accurate data collection. The data entry process is expertly coordinated, ensuring that all data seamlessly integrates into our well-structured databases.

In the clinical database development phase, our focus is on constructing robust and secure databases specifically validated for clinical trials. This process includes extensive building, screening, and testing of the database, coupled with rigorous quality control measures to guarantee the accuracy and reliability of the data stored. We also conduct User Acceptance Training (UAT) sessions with sponsors and study sites to ensure that all parties are proficient in using the new systems and that the database adoption is smooth and effective.

User administration is a critical aspect of our services, involving meticulous management of access and permissions within the system to maintain data integrity and security.

Throughout the trial, we ensure efficient collection, capture, and storage of clinical trial patient data, as well as study-specific documents through our advanced EDC applications. We continuously monitor EDC metrics and implement data cleaning procedures to maintain the accuracy and completeness of the data. As the study concludes, we prepare the final datasets, which are organized and validated, ready for analysis and reporting. This comprehensive management ensures that our clients receive the highest quality data for their research and regulatory submissions.