Omda Compos

Effective monitoring of the efficacy of drug treatments and treatment protocols relies on the collection and seamless sharing of comprehensive, timely, and high-quality data. The Omda Compos set of solutions are designed to facilitate robust management and seamless sharing of medical data throughout the clinical ecosystem. This platform ensures data accessibility for users and applications involved in clinical studies and registries, enabling streamlined collaboration and data utilisation.

Omda Compos Quality Registries (QR)

Omda Compos QR is the cornerstone of the Compos platform, encompassing a robust database architecture, data warehousing capabilities, user management, and other essential features that ensure data accuracy when managing medical data, from its collection to analysis.

User management

Efficiently granting user access and simplifying logging controls and data management are paramount for any registry or trial. In Omda Compos QR, users are assigned roles that determine their access to specific sites and, consequently, the associated patient data. Site coordinators or our team can manage the level of data access, ranging from limited to full, based on user roles.

Data export management

In Omda Compos QR User Management, users can access data based on assigned role and permissions. This maximises the utility of available data and enables users to build their own data warehouses or generate custom reports. Extracting data is simplified through an interface that allows users to replicate queries consistently.

Omda Compos Decision Support (DS)

Omda Compos DS is a versatile electronic data capture system and decision support tool for use in clinical settings.

The Patient Overview in Compos DS enables the collection and presentation of patient data, bringing together vital information from a patient’s medical history, disease status, laboratory results, examinations, treatments, side effects, symptoms, and quality-of-life indicators. This information is compiled and clearly presented through graphics and tables.

All entries in the Patient Overview follow a structured framework with standardised terminology and various pre-sets for data entry. This structured approach allows for seamless data transfer from the Patient Overview to quality registries, studies, or clinical trial databases.

The accumulated data offer valuable insights to clinical researchers and other professionals in medicine and academia who strive to advance medical practice and healthcare. This includes the development of new treatment strategies, monitoring and evaluating the effects of new drugs, understanding side effects, and making evidence-based decisions to promote equitable care.

Omda Compos DS is commonly used in clinical settings, offering healthcare professionals a comprehensive overview of a patient’s medical history and current situation. As part of the Patient Overview, Omda Compos DS incorporates information obtained directly from patients through Omda Compos PM (Personal Measurements), allowing for continuous monitoring of the patient’s progress and quality of life.

Each site maintains its own patient database, which can be seamlessly integrated with other systems within the Omda Compos platform. With patient consent, data can be securely and efficiently transferred to national quality registries or clinical trial databases through automatic data sharing.

Omda Compos Personal Measurements (PM)

Omda Compos PM is a web-based standalone solution that allows patients to provide vital information on their health and progress. These patient-reported outcome measures (PROMs) are invaluable in clinical trials, providing access to patient-reported data through a user-friendly interface that supports a wide range of validated digital forms.

Why personal measurements?

When investigating health economic measures or treatment responses, there is often a lack of patient-reported data in health records or databases.

PROMs reflect the patient’s experience of their illness and health in relation to their treatment or intervention. Surveys are frequently used to gather this information, allowing patients to estimate changes in their health, or report their current health status, at different points in time. PROM measurements reflect a patient’s own perceptions of health outcomes, providing essential information for the development of better and more patient-focused care.

When is it used?

Omda Compos PM is employed when a systematic understanding of self-reported outcomes is desired, both at the individual patient level and in patient groups.

The tool supports multiple use cases, including monitoring perceived benefits and issues, comparing the effects of different treatments on patients’ self-reported health, conducting health economic analyses, running national comparisons through national quality registries, supporting patient safety initiatives, and identifying at-risk groups that may require targeted interventions. The solution can be used independently as an e-form service with a digital dashboard or as importable e-forms within Omda Compos DS.

Omda Compos Statistics and Analysis (SA)

The Omda Compos SA solution supports both real-time data monitoring, as well as advanced statistics and reports on clinical studies and drug follow-up.

Omda Compos SA leverages business intelligence (BI) for the analysis of large volumes of data spread across multiple sites. It proves to be an especially effective tool when data is gathered without a specific protocol. BI allows for real-time data utilisation from various sources while maintaining the highest standards of data protection.

Analysis and reporting

Incorporating real-world data (RWD) into real-world evidence (RWE) demands both expertise in data analysis and a scientific approach. We collaborate with a network of academics and provide comprehensive reporting on health economics and clinical outcomes.

Omda Compos Adverse Events (AE)

Omda Compos AE is a dedicated system for the accurate documentation of adverse events. It complies with legal requirements and supports research and safety studies (PASS).

Adverse events must be reported to the Swedish Medical Products Agency (LV). Omda Compos AE integrates seamlessly with our electronic data capture system (Omda Compos DS), ensuring correct and accurate reporting.

medDRA coding

Using a standardised classification system for adverse events enhances understanding and monitoring, particularly when working across different geographies.

The Medical Dictionary for Regulatory Activities (medDRA) is available for the registration, documentation and safety monitoring of medical products, both before and after authorisation for sale. It encompasses pharmaceuticals, biologics, vaccines, and drug-device combination products. Omda Compos DS includes classification support and the latest medDRA coding version, supporting accurate reporting and centralised documentation for research and safety studies.

Omda Compos Clinical Trials (CT)

Omda Compos CT excels in clinical trial functionality, combining both electronic data capture (EDC) with data on patient-reported outcomes (ePRO).  

With access to the complete Compos family, Omda Compos CT secures that every clinical trial can be tailored to fit the specific protocol. The solution also offers familiar healthcare interfaces and a visit- or event-based logic for screening. Combined with the system’s adaptability to the protocol, this makes it easy for teams to work with the system.

Randomisation

Omda Compos CT includes randomisation capabilities and real-time patient and variable monitoring. You can choose whether to fully anonymise, partially anonymise, or not anonymise patient data. Maintaining protocol adherence throughout the trial and accurate data extraction are vital aspects. We provide support throughout the trial and possess expertise in analysing data based on the trial’s trajectory. Our practices comply with Good Clinical Practice (GCP) and ISO 13485 standards.

Our Services

Registry studies

The decision to initiate a registry study typically involves identifying the variables to be collected, determining the desired number of participants, and assessing data accessibility.

We conduct feasibility assessments in Sweden and the rest of Scandinavia for single or multi-registry studies, and have worked with pharmaceutical companies of all sizes and across various fields. Additionally, offer comprehensive support in identifying the best approach for registry studies, whether the study is a concise analysis of treatment patterns or a broader academic research project. In many cases, data from multiple registries may be required, and we have the expertise and technology to efficiently combine data from diverse sources.

Research collaboration

Through our collaboration with Halmstad University, we are uniquely placed to access over 50 linked databases of patient data. The master database integrates comprehensive data from various publicly-funded healthcare sources, including hospital/clinic encounters in primary care, outpatient specialist care, emergency services, inpatient care, ambulance services, and pharmacy visits.

This extensive dataset includes detailed information regarding diagnoses, procedures, medical notes, medications, and more. Additionally, patient demographics such as gender, age, primary care units, corresponding geography IDs, and other relevant information are extracted from national registers.

In addition, the database includes data on personnel utilisation, including nurses, assistant nurses, physicians, and medical secretaries, providing hourly and daily records from human resource data. It also incorporates codes for all care delivery units and care providers, enabling linkage of care encounters. The database also captures costs allocated at the patient-encounter level, allowing for a comprehensive understanding of healthcare expenses.

Examples of data types:

• Diagnosis
• Variables
• Treatment
• Effect
• Medications
• Income
• Education
• Heredity
• Lab values
• Demographics

Ongoing development projects

Having a system in place is one thing, but fully utilising its potential is another.

Omda can assist in promoting and maximising the utilisation of your register, EDC and PROM services. We take on projects to demonstrate the effective use of our systems and work with our extensive network to arrange seminars and meetings for best practice sharing.

We are committed to working closely with our clients to optimise their investments and help them achieve their goals through the efficient collection and analysis of well-managed medical data. Please feel free to contact us for a discussion on how we can assist you in achieving this.

If you are considering establishing a new register, we can help with process design and technology selection. In addition, we provide project management services that ensure you make informed decisions and navigate the process effectively.

Our services include:

• Lead user Heatmap
• Consultancy services
• Inspirational seminars
• Best practice white papers and media
• Patient recruitment projects
• Site and user recruitment projects