Discover how our platform integrates seamless operations from setup to delivery.
Learn moreAt Meliovit, the security of your data is not just a feature; it's a fundamental aspect of our commitment to advancing the field of decentralized clinical trials with utmost integrity and reliability.
We prioritize protecting healthcare data, especially in decentralized trials. Committed to security, we strictly adhere to HIPAA and GDPR standards, utilizing advanced encryption for participant confidentiality in Meliovit.
We utilize robust encryption for data at rest within our databases and for data in transit. This is achieved through TLS/SSL encryption, ensuring that data transmitted between database instances and applications is always secure.
Our system strictly implements IAM (Identity and Access Management) policies. This sophisticated approach controls and restricts access to AWS resources, ensuring that only authorized application servers have database access.
Leveraging AWS CloudTrail, we meticulously record API calls and monitor activities linked to our database resources. Additionally, we integrate AWS CloudWatch Logs and the Datadog monitoring solution for real-time surveillance of database logs. This setup includes alerts for any unusual activities, ensuring continuous vigilance.
We utilize AWS Config to regularly assess and audit our database configurations. This helps us maintain compliance with the stringent requirements of HIPAA.
Our approach to data protection includes regular (daily / hourly) encrypted backups, securely stored to ensure data integrity. Moreover, our production environment encompasses comprehensive disaster recovery plans. These plans are routinely tested to guarantee data recovery in the event of unforeseen circumstances, such as data loss due to misconfigurations.
At Meliovit, we understand the critical importance of keeping our tools, systems, and database versions up to date. Regular maintenance, patching, and updates are integral to our strategy for ensuring the highest level of data security and protection.
For a more detailed understanding of our adherence to HIPAA guidelines and the rigorous standards we follow, please refer to the HIPAA Compliance Documentation on AWS.
Meliovit is designed for quick setup and user-friendly operation, ensuring a seamless integration into your clinical trial processes.
Allows Sponsors and Project Managers have unparalleled control in setting up and managing clinical study parameters. Furthermore, it provides a comprehensive overview of all ongoing processes and deliveries for enhanced oversight and detailed reporting.
Investigators can register new participants, record their contact information, initiate DTP shipments and request DFP returns. Nursing staff, while having access to participant and shipment details, can receive notifications about upcoming deliveries, ensuring they are well-informed and ready to assist when needed.
Facilitates processing of DTP and DFP shipments in any setup (Depot-to-Patient, Site-to-Patient, or hybrid). Equipped to handle both blinded and unblinded operator roles, it features an intuitive layout for tracking shipment phases, from initiation to delivery. The app integrates various stages, including request processing, courier coordination, and shipment tracking, ensuring precise and timely logistics essential for decentralized trial efficacy.
The Meliovit mobile app, compatible with both iOS and Android phones, offers participants a seamless way to manage their medication deliveries. With features to track deliveries, receive notifications, and confirm receipt, it ensures participants are always informed and engaged. Additionally, the app enables users to provide critical feedback on the viability of package contents and inform study staff when assistance is needed, thereby enhancing efficiency of logistical operations.
Meliovit's robust system, including Investigator Portal, Shipments Hub, and participant mobile apps, ensures secure data handling and documentation for decentralized trials. Its digital architecture streamlines processes and boosts decision-making accuracy, essential for modern trial management.
Meliovit streamlines communication through a comprehensive notification system designed to keep all stakeholders informed. Our platform ensures timely and relevant updates, enhancing the efficiency and responsiveness of supply chain management.
Participants receive alerts about the status of their medicinal product deliveries, including dispatch and expected arrival times.
Notifications for confirming the receipt of deliveries, ensuring investigators and nurses are informed on time.
Prompts for participants to provide feedback on the condition and viability of received packages.
Participants can inform their study staff of any issues that can be handled promptly to prevent unnecessary delays and delivery failures.
Alerts when a new participant is successfully registered via IRT software.
Updates when a shipment request is processed, providing transparency in order management.
Reminders for participants to verify their details, ensuring accurate and up-to-date information.
Notification of delivery success and package viability.
Notifications about upcoming deliveries, or sample returns, enabling nursing staff to prepare for any required assistance.
Immediate alerts when new shipment requests are made, initiating the processing phase.Courier Dispatch Confirmations: updates when couriers are dispatched or when manual courier ordering is required.
Alerts indicating the completion of a shipment’s journey, marking the end of the logistic process for the Hub.
Customizable notifications based on predefined timeout thresholds, such as “Maximum time to delivery”, facilitating immediate alerts if there are delays or issues in the shipment process, enabling quick intervention.
We are currently building Meliovit’s reporting functionality to offer Sponsors an in-depth analysis of various performance metrics, essential for monitoring and optimizing Direct-To/From-Patient shipments.
Track the average time taken from the order request to successful delivery to participants.
Percentage of deliveries that arrive at the scheduled time.
Measure the time taken from return request initiation to actual pickup.
Percentage of returns successfully processed and completed.
Assess the condition of returned items, ensuring they meet quality and safety standards.
Monitor the average time taken by participants to confirm receipt of deliveries and package viability.
Measure the effectiveness and speed of resolving delivery-related issues reported by participants.
Assess the reliability of courier services based on timeliness and delivery success.
Monitor the responsiveness of courier partners from dispatch request to pickup/delivery.
Evaluate the efficiency of different hubs in processing and dispatching orders.
Monitor compliance with temperature requirements for sensitive shipments. Possibility of integration with “smart” t-loggers for real time overview during the transit process.
Assess the frequency and outcomes of integrity checks for delivered and returned items.
We understand that each clinical trial has its unique requirements, especially when it comes to the logistics of Direct-To/From-Patient shipments. Meliovit offers extensive customization options to align perfectly with your trial’s specific needs.
To offer complete flexibility in any standard or hybrid delivery setup.
Ability to deliver not only medicinal products, but also ancillary and promotional materials.
Customizable integrations with IRT software, courier partners, or smart trackers.
Customizable notifications, alerts, and reports
