cam ^tech Main Features • Secure 256 bit data encryption • Locked down site version reduces possibility of set-up errors • No transmittal of patient identification required • Suitable for medium to large scale, multi-site projects • Suitable for small scale projects where subjects are widely geographically dispersed • Integrated within CamNtech Software Cloud Data Management (CDM) System The CamNtech Cloud Data Management (CDM) system provides a secure and convenient method for patient data collection and management in mid to large scale clinical trials. Typically clinical trials require large cohorts often with wide geographical distribution. Regularly collecting individual patient data and transferring it securely to the CRO or sponsor can be burdensome. The CDM system has been specifically designed to reduce the data management burden by providing a means of securely transferring patient data to the management HQ. The most common model will comprise of multiple branch sites, each managing a number of patients. During each patient visit the device data is uploaded to the secure server and the device is re-set for the patient to continue their recording. The HQ site (CRO or sponsor) can then download the data immediately for analysis. The data have automatic 256 bit encryption during upload and decryption at the HQ site with the CRO or sponsor having full control over the encryption key thus providing high levels of data security. The data are also protected by a further key generated during download which ensures that the data cannot be tampered with or corrupted without warning hence providing excellent data integrity. The system does not require any sensitive patient data to be recorded thus ensuring high levels of patient privacy. The figure below shows how the CDM system can function in a large scale study: CamNtech Ltd Upper Pendrill Court, Ermine Street North Papworth Everard, Cambridge CB23 3UY, UK Tel: +44 (0)1480 831223 Fax: +44 (0)1480 831733 Email: [email protected] www.camntech.com Issue date March 2017 Product specification subject to change without notice

Cloud Data Management (CDM) System The remote computers can utilize a locked-down version of the software with set-up based upon a configuration file. This ensures that the risk of set-up errors at the branch sites is minimised as there are no user configurable controls. The configuration file allows control of key user interface options and allows an identical protocol to be easily applied to multiple sites. The data are automatically tagged with patient ID, site name and site code to simplify data management at the HQ. Create Configuration File Import Configuration File (branch) Branch User Interface...