Get accurate, secured and fully exploitable Clinical Databases

Our state-of-the-art solutions for efficient Clinical Data Management

Clinical Data Management (CDM) in clinical trials is the task of collecting/managing data according to regulatory standards.

It helps to build exploitable study datasets and ensure the quality, accuracy, and integrity of the trial data.

CDM also has the role to minimize errors and discrepancies in the data, reduces the risk of data loss, and streamlines the process of collecting and analyzing data.

Our Data Managers team are dedicated to providing comprehensive CDM services to support the success of your research studies and trials :

CRF/eCRF developpement: We design, create and deploy user-friendly (electronic) Case Report Forms to collect the study data at baseline and during follow-up.

Database design: We create study databases in a highly secured environnement. We use SDTM/ADaM standards for fast and efficient clinical data submission to the regulatory authorities
Quality control: By deploying our Electronic Data Capture (EDC) solution, we continuously monitor quality of data entries through programmed ‘Edit Checks‘. We set automatic routines to identify and correct missing data, inconsistencies and inaccuracies

Safety Data Coding : We use the up-to-date version of Medical Dictionary for Regulatory Activities (MedRA) to code safety data as Adverse Events and Serious Adverse Events.
Database lock : Once the study closeout phase is over, we finalise and lock the complete database to deliver to biostatisticians.