OOMNIA – THE FIRST TRUE ALL-IN-ONE CLINICAL TRIAL SOFTWARE

The phase of implementation lays the groundwork for a clinical trial. It encompasses the crucial steps of planning, designing, setting up, and ensuring access. This phase is characterized by meticulous preparation, where trial objectives and methodologies are defined, trial sites are selected, staff are recruited and trained, and regulatory approvals are obtained. It’s a phase of strategic planning and logistical arrangement, ensuring that the trial is poised for success with a solid foundation and clear access paths for participants.

The conduct phase is where the clinical trial itself comes into action. This phase includes enrolling participants, collecting data, and monitoring the trial’s progress. It is especially marked by active engagement with participants, where their data is collected and analyzed to assess the efficacy and safety of the intervention. Continuous monitoring ensures the trial adheres to its protocols and maintains high ethical and safety standards. The success of this phase is crucial as it directly impacts the reliability and validity of the trial results.

In the closure phase, the trial begins to wind down. This phase involves closing the trial sites, ensuring all data collection is finalized, analyzing the gathered data, decommissioning the trial infrastructure, and formally ending the trial. It is a period of reflection and conclusion, where the results are synthesized and prepared for reporting. The closure phase ensures a responsible and comprehensive wrap-up of the trial, paving the way for marketing authorization and improved patient outcomes.

The lessons learned phase is an opportunity for evaluation of processes and technology after the trial has concluded. It focuses on analyzing the successes and shortcomings to improve future research. This phase involves a thorough review of the entire trial process, identifying best practices, and considering stakeholder feedback. It culminates in scaling the successful elements of the trial, applying the lessons learned to broader contexts, and influencing future practices and processes. This phase is vital for the continuous improvement of clinical research methodologies and their application in real-world scenarios.

The planning and design step is the first and most important step of any clinical trial process. During this step and the overall implementation phase, data management and biostatistical teams, aid in defining study objectives and endpoints, perform the sample size calculations, create the randomization schedule, analyze the trial design, and design the data collection instruments. Additionally, regulatory documents supporting trial processes are written by experts. These steps are performed so that the study can meet its endpoints, and to ensure the validity and reliability of the trial results.

The set-up step is a critical moment when the clinical trial infrastructure is implemented. This includes the creation of the trial organization structure, implementing the eCRF and other data collection instruments, as well as randomization schedules, and the eTMF structure. Training staff and writing all user manuals and instructions must be completed for the trial to run smoothly. Regulatory documents and plans supporting trial processes are written by experts so that trial conduct is documented for all staff. This step ensures that the trial is conducted efficiently and is in compliance with all guidelines and regulations.

In the step of access, the focus is on ensuring that all trial staff have appropriate access to the digital tools they need to perform their tasks. This means giving them access to the oomnia system with the eCRF, or other EDC documents, as well as modules they need. This can be the RTSM or eTMF. It is important that the organizational structure created in step 2 is tested well so that site and CRO staff only receive access to data from organizations to which they are allowed access. Enhanced security measures such as two-factor authentication is also set at this point.

The first step of the trial conduct phase is when participants are actively recruited and enrolled into the trial. Using a unified system, this means that the investigational medicinal product (IMP) must be sent to and received by sites and the events be logged in the trial management system. As the randomization schedule has been uploaded and auto-detection of strata has been set, with the integrated RTSM and eCRF study staff enroll trial participants, allocate them to treatment, and stratify them with only one click.

Accurate and consistent data collection is crucial for the validity of the trial results. In the step of data collection, researchers systematically capture data via the eCRF or other EDC documents as per the trial protocol. A unified system allows for the collection of eCRF data, protocol deviations, SAE report forms, as well as eTMF documents. By eliminating the need for the use of disparate systems, data transfer, copy pasting or data input into multiple systems, a unified system like oomnia helps to ensure data quality and integrity while reducing workload.

Monitoring a clinical trial involves far more than source data verification (SDV). With a unified system and almost unlimited analytics capabilities, trial monitoring and oversight takes a new form. Performance of SDV, medical review and data management review can be tracked and followed by all parties in real time. Integrated reports can be used to track monitoring visits, actions recorded in the CTMS, eTMF completion, and much more. Real-time statistical analyses enable risk-based monitoring and the visualization of site performance and comparisons. Prompt identification of issues to ensure trial integrity and participant safety is simple.

For participants, this steps marks the end of the active stage of the trial. It involves ensuring all data collection is complete and accurate. All SDV must be performed, as well as medical review of the data. Access to the database is highly restricted to ensure only data which is necessary to be updated is changed. Proper lock and closure is essential for statistical analyses.

Analysis is a critical step where collected data is systematically examined to draw conclusions about the trial’s outcomes. This involves statistical analysis to assess the efficacy and safety of the intervention, interpreting results, and preparing the final reports. The accuracy and rigor of this step are crucial for the reliability of trial outcomes.

Decommissioning of the digital trial infrastructure occurs after all statistical analyses have been completed and access to EDC documents and modules is no longer required by any trial staff. All documentation must be finalized and any unused materials and IMP must be disposed of or returned. All digital documents must have been transferred to the sponsor, and access to the trial is revoked for all staff. Checks involved in this step ensures that all aspects of the trial are concluded responsibly and in compliance with regulatory requirements.

The step of improvement focuses on lessons learned from the trial. This involves analyzing what worked well and what did not, identifying best practices, and considering feedback from all stakeholders. The insights gained are used to refine processes, improve trial designs and the software, and enhance future clinical research practices.

Scaling involves applying the successful strategies and lessons learned from the trial to broader contexts. This may include creating templates for future trials and  adapting its methodologies for future projects. Successful scaling maximizes the improvements and efficiencies in future projects, and contributes to accelerated drug discovery and improved patient outcomes.