Project and Data Management

Project management

Each study is managed by an experienced project manager and his back-up, from the establishement of commercial proposals to the study closure.

The project manager coordinates our activities, and also those related to external partners or suppliers, and especially interacts with our customers.

Our team has already managed more than 200 clinical studies for 50 different customers.

An online tracking tool, thanks to a secure web interface customized for each study, is available for our customers to follow the progress of CDL Pharma's activities in real time (production and supply of sampling kits, shipment of biological samples...).

Data management

For more security, confidentiality, and to optimize the transfer of samples and associated data to analytical laboratories or sponsors, CDL Pharma offers a proven solution for data management.

The requirements for CDL Pharma data solution are as follows:

• Design of a database according to the customers specifications
• Writing of the data validation plan and the transfer protocol
• Validation of the database before use (entry of dummy data)
• Independent double data entry, interactive double data entry or simple data entry
• Data import
• Setting up and running of consistency tests
• Sending and management of queries (DCF) with investigation centers
• Secure transmission of data (transfer during and at the end of the study)
• Database freeze
• Preservation of data in accordance with regulatory requirements