The new service has been developed in conjunction with all applicable regulations and guidelines which apply when running clinical trials in multiple countries. These regulations include: HIPAA and other internationally-equivalent data privacy laws, General Data Protection Regulation (GDPR) and validation of computer systems. New operating software and a new set of Standard Operating Procedures have been developed with strict training requirements. The new operating software aims to reduce the paper-based study visit documentation, enable real-time, secure document transmission and improve project oversight.
These new services can be integrated with Marken's other services such as: storage of clinical drug product in its depot network, utilization of its central pharmacy services and coordination with its global courier services.
Wes Wheeler, chief executive officer of Marken said, "We are excited to launch our new home healthcare service on a global scale. Decentralized clinical trials are becoming more common and we are working to ensure that we meet the needs of our clients as they transform their own industry. We see our home-based nursing network as an important new service which can improve patient recruitment, patient retention, and a more integrated solution."