This collaboration is set to transform the Life Sciences sector by leveraging Deloitte’s expertise in process management, validation, onboarding, and consulting, alongside Flex Databases’ state-of-the-art electronic systems.
Bionical Emas is the only CRO to combine Clinical Development, Early Access Programs and Clinical Trial Supply, to deliver a unique, seamless approach supporting our clients to bring new medicines to patients faster.
“Our partnership relationships are paramount to everything that we do, and we work closely with our clients to become an extended part of their team. We understand that we are ultimately dealing with patients’ lives. This drives our philosophy to challenge the norm and bring new medicines to patients faster.”
We’ve asked Manish Patel, Systems Manager, Clinical Operations a few questions about the upcoming partnership:
Why Bionical Emas decided to pick Flex Databases as a CTMS provider?
Bionical Emas Clinical Development has selected Flex Databases as a computer system supplier for Clinical Trial Management System (CTMS) because it is known for flexible eClinical platform for full-cycle clinical trial management.
It is a secure and validated platform, offer baseline solution that fulfil our business user requirements, require minimum implementation time which allow to transit from one to another system for fast pace on-going clinical trials.
It allows project team to complete their day-to-day study and site management related activities such as site selection, submission tracking, site monitoring, site payment in system efficiently to eliminate manual tracking which can lead to human error, and able produce metrics and reports in real-time.
What do you expect to achieve with the implementation of Flex Databases CTMS?
Quick implementation in line with GxP system validation compliance that allows to migrate on-going as well new studies.
Validated integration between Flex Databases and Electronic Data Capture (EDC) solution to allow pull subject and visit related information for site payment activities and subject enrollment planning.
User training and access to training materials.
Is there a particular feature or several that you like the most?
- Intuitive and easy to navigate
- Smartly structured and easily searchable contact information
- Tracking projects by type, trial or any other component
- Automated notifications on delays can be set up with monitoring visit report generation, approval and finalization
- Configurable site level tracking e.g. issue/action item, communication log, protocol deviation log, equipment tracker, SAE tracker, subject enrollment log, procedural deviation etc.
- Offline Monitoring Visit preparation
- Site accrual and invoicing tracking
- Site feasibility and qualification process
- Reg/IRB/IEC submissions and approval tracking
- Documents tracking (contracts, site regulatory documents, licenses and certificates)
- Ad-hoc reporting tool for cross-project and cross-module reporting (graphs, widgets)