Randomization and drug supply management fully integrated with EDC, CTMS, and eTMF
Automate randomization and drug supply management directly in the eCRF
The RTSM module of Oomnia CRIS controls patient randomization, automates Investigational Product (IP) supply to depots, sites, and patients, and handles drug dosing and dispensation. The automation of supply and logistics management has made it possible for trials to include a broader and more diverse set of patients across the globe. The system can be set up quickly and altered rapidly when necessary. This automation can reduce the trial duration by weeks, which saves money and ultimately enables the delivery of therapies to market sooner.
The Oomnia RTSM module can also be utilized as a stand-alone service if a different EDC system is required.
Randomization, allocation, dispensing, accountability, and re-supply requests are integrated directly within Oomnia EDC eCRFs for easy access by site staff and study teams without the burden of logging into a separate system.
Oomnia RTSM provides immediate, real-time access to view current randomization status, drug supplies onsite, ordered, and in transit. Alerts are sent for any supply shortages to prevent recruitment delays, and customized alerts are tailored according to each clinical trial’s need.
By integrating real-time tracking and automated tasks into the RTSM module, trial sponsors and study teams can effectively manage the logistics of study drug distribution, minimize delays, optimize inventory levels, and ensure the timely availability of kits to participants, thereby enhancing the overall efficiency of the clinical trial.
Easy access to IP accountability records.
Ensure appropriate users access privileges to maintain data confidentiality, integrity, compliance, and security of the clinical trial.
Randomization, IP allocation, and EDC reconciliations.
Integrate with EDC for automatic randomization and IMP-associated edit checks.
Real-time drug supply insights
The solution fully reflects the sequence of actions and logic in supplying the IMP to all subjects participating in the study. All aspects are considered, including the expiration date of the kits, providing real-time drug supply, allocation, and current per-kit status at the site-, depot-, and trial-levels.
Built-in data checks
Built-in verification and validation mechanisms within the eCRF provide a safeguard to ensure only qualified participants are assigned and allocated IMP, and help prevent manual entry, dosing, dispensing, and accountability errors.
All designated team members and site staff will receive automated alerts according to predefined User roles as determined by the client. The alerts are customized per study and client requirements to deliver optimal communications and oversight capabilities.
Report generation per client needs, which can be used to support eTMF documentation requirements
The system can generate any report around any given parameter, able to generate reports on a patient-by-patient basis as required for filing in the eTMF.
Optimized unblinding process
Oomnia RTSM utilizes User-based permissions to ensure only authorized individuals with the necessary roles and responsibilities can access unblinding information. This approach maintains data confidentiality, protects participant privacy, and adheres to the blinding requirements of the clinical trial protocol. It also provides a robust audit trail and promotes transparency and accountability in the unblinding process.