The University intends to award a service contract to Diamind Solutions Inc to provide the
following services:
• Development of randomization, management, simulation, and finance management platform
for supporting various Clinical Trials, primarily for the phase 3 international RCT Escape-
MeVO
• Ability to define a patient lifecycle and to track completion of milestone events through the
lifecycle, as well the ability to report on the lifecycle status of each patient
• Ability to provide software to facilitate drug and device trials in Health Canada and Federal
Drug Administration (FDA) regulated environments
• Validation and other required documentation in support of regulated clinical trial execution.
• Regulatory compliance required for Health Canada, Food and Drug Administration (FDA), as
well as various EU and UK regulatory bodies
• Human Ethics and patient confidentiality compliance
• GCP E6 validation and FDR CFR documentation requirement adherence for validation
• Integrate platform to third party EDC system/platform, in order to send, receive and update
information securely and timely between systems
• Business Critical, 24/7 Support, maintenance and ongoing feature development as required
for the platform in support of multiple trials and initiatives
• Architecture and operation of servers and infrastructure (hosting) required to support
projects with business critical/guaranteed uptime
• Novel patient randomization module based on most current stratification and minimization
algorithms from literature, industry and trial execution experience.
• Financial management module to facilitate and optimize clinical trial site operational
processes and fiscal accountability
• Secure platform access and administration capabilities, such as encryption at rest and in
transit, multi-factor authentication and role-based access controls that can be configured on
a per site basis
• Ability to support blinding protocols and hide certain information fields based on the user’s
role and access to a specific site
• Ability to capture and modify patient information and to synchronize this information via an
API to a third-party EDC solution
• Ability to lock patient records as required
• Documentation to fully support workflows and clinical trial processes
• Complex randomization simulation and reporting to ensure adherence to approved protocol
directives
• Data pulls and reporting as required, in alignment with Data Safety Monitoring Board
requirements
• Short turn around on change requests and feature development, in addition to 24/7 support
services
• Audit Log that tracks all actions taken by users in the platform and provides review
mechanisms for Regulatory Audit compliance
• Release versioning and communication
• Full management of user, role, site, reporting, notification, and profile settings
• Fully-featured list searchability and sorting throughout modules
• Document management capabilities that allow for secure storage of trial and site specific
documentation, with specific access controls
• Ability to define notifications and to allow users to enable/disable notifications as desired
