Unified software and service solutions for clinical research organizations
Enhance Sponsor Collaboration, Automate Processes, and Deliver Real-Time Insights
- NIncreased efficiency
- NReal-time insights
- NReduced costs
- NUnmatched competetive advantage
Unified software and service solutions for clinical research organizations
Enhance Sponsor Collaboration, Automate Processes, and Deliver Real-Time Insights
- NIncreased efficiency
- NReal-time insights
- NReduced costs
- NUnmatched competetive advantage
Comprehensive solutions to elevate CRO performance
Software and services tailored to make CROs stand out to sponsors
We provide more than just software — we partner with Clinical Research Organizations (CROs) to deliver the tools and support they need to excel in every aspect of clinical trial management. Our unified platform and expert services are designed to streamline clinical operations, improve data quality, while reducing timelines and costs, making CROs more efficient and attractive to sponsors.
Whether your CRO needs support with protocol development, data management, real-time analytics, medical writing, and/or biostatistical services, we empower CROs to meet sponsor expectations, reduce trial timelines and costs, while delivering exceptional results. With our industry-leading tools and services, CROs become a trusted partner for sponsors, equipped to handle even the most complex trials.
Exceed sponsor expectations every time
Strengthen CRO-Sponsor relationships
Building trust and efficiency for long-lasting partnerships
Increased efficiency
Superior data quality
Meticulous compliance
Cost reduction
Enhanced collaboration
Simpler patient engagement
Maximal scalability and flexibility
Unmatched competitive advantage
Tailored support and complementary CRO-Services
Select the services you need to enhance your operations
Protocol Development
With expertise in study design, our team develops protocols that are both scientifically robust and practically implementable. Additionally, we provide expert consultations to ensure that protocols comply with current regulations, helping to avoid delays in the trial process.
eTMF Setup and Administration
Our eTMF services include the creation of eTMF plans, the development and implementation of eTMF structures, and proficient eTMF management and administration throughout the study’s lifecycle. The eTMF system is continuously updated and maintained to guarantee compliance and transparency throughout the trial.
Clinical Data Management
Our approach to clinical data management relies on professional data collection, processing, storage, and analysis techniques. Expert clinical data managers guarantee a thorough alignment between the protocol and data capture instrument design.
Risk-Based Monitoring and Source Data Review
We prioritize monitoring activities based on thorough risk management, focusing on the most critical data. This proactive approach allows us to identify and resolve data discrepancies and compliance issues quickly, ensuring smoother trial management.
Biostatistics and Statistical Programming
Our team of experienced PhD level biostatisticians conducts complex data analyses to validate study outcomes. We also ensure that all statistical evaluations meet regulatory requirements from authorities such as the FDA or EMA, ensuring compliance throughout the trial.
CDISC-Compliant Dataset Generation
With deep expertise in CDISC standards, we generate datasets following SDTM and ADaM guidelines, facilitating smooth submission to regulatory bodies. We also ensure that all datasets are consistent and of the highest quality to meet submission standards.
Medical Writing and Documentation
Our professional medical writers prepare clinical study reports, summaries, and other key documents with precision. Leveraging their regulatory expertise, they ensure that all documentation meets the necessary requirements for submission to regulatory authorities.
Curious?
Choose the clinical trial tolls you need
Start with what you need and add more tools over time
EDC/eCRF
Precision in data management
Within oomnia, our Electronic Data Capture (EDC) tool offers comprehensive capabilities, including user-friendly configuration, controlled user access, and data integration and processing. This integration extends to IMP randomization directly within the electronic Case Report Form (eCRF) document, streamlining the data collection process. Our expert support team stands ready to assist at every step, ensuring the highest standards of data accuracy and security throughout your clinical trials. Trust oomnia for precision in data management and efficient trial execution.
eSource
Connecting all digital data sources
oomnia has powerful eSource capabilities, which enable you to connect all other digital data sources to omnia EDC. Our software is able to capture all kinds of electronic source data in real-time, such as electronic health records (EHRs), wearable technologies or mobile applications. In this way, we are ensuring highest data accuracy and enhanced clinical workflows.
RTSM
Enhancing trial efficiency
Within oomnia, our Randomization and Trial Supply Management (RTSM) module offers complete lifecycle coverage for kit shipment tracking and real-time status updates. From randomization, and allocation to treatment, as well as accountability, and end-of-trial randomization report exports, the RTSM as part of a unified system reduces manual data entry and streamlines the entire trial process by increasing transparency and eliminating needless manual reconciliation. By optimizing supply chain management and data accuracy, oomnia's RTSM tool ensures efficient and error-free clinical trials, saving time and resources for research teams.
eTMF
Streamlined document management
oomnia incorporates electronic Trial Master File (eTMF) capabilities to optimize your document management process. Benefit from real-time reports, a rapid startup timeline, and effortless document management. Our eTMF tool ensures insights into your trial's progress, and it is exportable to a fully validated eArchive for long-term data storage. Count on oomnia for comprehensive document control and efficient trial management, empowering you with convenience and confidence throughout your trials.
ePRO
Revolutionizing data reporting
Within oomnia, electronic Patient-Reported Outcomes (ePRO) emerges as a vital tool. Patients can seamlessly report their health data through smartphones, tablets, or web-based platforms, enhancing their active engagement in the healthcare process. This integration not only boosts patient involvement but also elevates data quality, delivering a more precise understanding of a patient's health. With ePRO as part of oomnia you benefit from improved communication and streamlined data collection, ultimately enhancing the quality of care.
eCOA
Elevating clinical assessments
oomnia seamlessly incorporates electronic Clinical Outcome Assessments (eCOA) for comprehensive data collection and documentation. Utilizing electronic devices such as smartphones, tablets, or web-based platforms, eCOA enhances data integrity and efficiency in clinical assessments. This integration simplifies the process, ensuring accurate and timely collection of vital clinical data, ultimately advancing patient outcomes.
eConsent
Simplifying consent processes
oomnia eConsent enables patients to choose the most convenient consent process. Our solution supports electronic as well as paper-based consent methods. It further comes with numerous features. Our tool reduces language barriers by providing consent documents in multiple languages. In addition, the interactive Q&A module allows participants to directly communicate with site staff, which gives them opportunities to raise concerns or questions. The digital signing process reduces the time needed to disseminate consent information to just three minutes.
CTMS
Elevating trial management
oomnia integrates Clinical Trial Management System (CTMS) features to enhance your trial management experience. Our platform offers customized dashboards per user role, standard study templates, and logs for efficient trial setup. With key performance indicator (KPI) reports, monitoring visit tracking, and timeline/milestone tracking, you gain full visibility into your trial's progress. Additionally, our CTMS tool covers contract management and budget/payment management, ensuring comprehensive trial oversight. Trust oomnia for streamlined and data-driven trial management that empowers you to achieve your research goals effectively.
oomnia – Surpassing Industry Standards
Our unified clinical trial software is designed with compliance at its core, meeting critical industry standards. Our commitment to these regulations ensures that your clinical trials are not only efficient but also adhere to the highest levels of data integrity, privacy, and ethical conduct.
Efficient trial management features
for your success
Discover powerful tools to streamline operations and impress sponsors
Our system covers everything essential for clinical research, ensuring a comprehensive approach to clinical data management. The user-friendly data entry, thorough monitoring, and advanced statistical capabilities enhance your research process. With regulatory compliance and a reliable supplier profile, our solution meets the diverse needs of clinical researchers. Discover more functions in the following eight categories.