Randomization was the original reason software developers were recruited to PHRI and it remains the core feature of ROME today.
check Geo-stratification by country or site and additional stratifications as needed.
check Import and validate tool for randomization schedules
check Open, single or double blind trial designs
check Unique cluster cross-over study designs
check Emergency and Pharma-Covigelance unblinding
assignment_returnedDispensationsIf your study involves an investigational product, ROME is designed primarly for this scenario. ROME is able to dispense single medications to complex combinations of medications all while maintaining a blind if necessary. If mid study titration is required, just define the conditions when it should take place and ROME will dispense the appropriate dosing. If you need to supply participants with Run-In medication, ROME is designed to support that scenario with ease.
The visit forms are flexibly designed to match your protocol requirements. You decide on the number of visits required, the questions and the edit checks, plus the layout. All data is audited and electronically signed.
eventParticipant Visit Schedules
First setup your visit maps for your study. When a participant is recruited into the study, a detailed visit schedule specifically for the participant with exact dates can be printed and given to the participant.
Efficient site identification and initiation processes are critical to the success of a large study. ROME offers intuitive tools for the coordinating office and sites to manage and maintain their address information and personnel. Enable/Disable functionality at a site level to ensure compliance and safety. ROME integrates with EDC systems so you only have to manage this information in one spot.
ROME has built-in functionality to allow for easy integration with other EDC services.
Single or double blind studies require a robust system to ensure the integrity of the study. ROME offers validated tools to dispense IP according to the randomized allocation while maintaining the blind. The inventory tools are designed the same way. When a blind is required, all involved in the supply chain can do their work without compromising the blind. ROME monitors the supply levels and places orders on behalf of sites and depots accordingly to ensure that inventory levels are adequate to meet recruitement and resupply demand.
ROME offers tools targeting the IP Managers of studies that allow the import and validation of packaging lists, the import of label batches and lots into inventory. From the beginning, ROME was used for large, global trials and the tools reflect that. To support your QP process, batches can be released to countries for import only or for import and distribution. Configure depots to receive shipments from specific depots and to ship only to specific countries.
Ensuring accurate inventory across all depots and sites in a large global trial or a small single site trial is essential. ROME makes this easy by providing simple to use tools to receive shipments into their inventory, quarantine or damage inventory on receipt or after, dispense inventory to participants. ROME keeps a detailed audit trail of all activity related to each individual product throughout the entire product lifecycle. From import to consumption or destruction.
loopOrders and Shipments
You have imported your initial supply to your central depot. Now you need to move into a local depot and distribute it your first site. ROME has tools to manually place orders on behalf of depots and sites. ROME's order fulfillment algorithm selects the correct inventory items and notifies the supplier of the shipment. All while ensuring the blind is maintained and the optimal ratio of blinded product types is included.
assignment_turned_inAutomated Order Generator
Let ROME intelligently monitor the inventory levels of every site in your study and place orders just-in-time. You have an expensive product or is it difficult to store for the sites? No problem. Apply a supply strategy that ships small orders more frequently. You have an inexpensive product that is easy to store? No problem! Apply a supply strategy that ships larger orders less frequently to save on shipping costs. All this while ensuring the correct underlying product type according to the randomization schedule is physically available on their shelf!