End-To-End Technology Support for Clinical Research
Why Clinovera?
Clinovera has been providing end-to-end technology and medical informatics support for researchers and innovators at multiple Academic Medical Centers, Clinical Research Organizations, and other research entities for over 20 years. We have a multidisciplinary team of medical informaticians, clinical and research analysts, and engineers highly skilled in facilitating research funded by public or commercial grants. We have developed efficient methodologies, processes, components, and accelerators focused on specific clinical and research areas, such as Remote Patient Monitoring, care quality and safety improvements, clinical pathways, Real World Evidence research, and others.
What Clinovera Does for Research Community
Clinovera offers comprehensive services and solutions for clinical researchers and innovators. From the early stages of study ideation and grant applications to running the study, to results analysis and publication we work with research teams side by side helping them with every aspect of relevant HeathIT needs.
Below is a list of specific service offerings we offer for every stage of the research study lifecycle. As objectives, requirements and timelines vary greatly between studies, the services we offer may be needed at different phases of the study.
Funding and Grant Application Stage
At this stage, we help research teams to define and capture necessary technology vision and needs and to produce required artifacts for timely and successful grant applications to maximize the likelihood of obtaining the funding.
Services We Provide
Services offered may include all or any of the following:
- Understanding budgetary requirements and constraints and developing a supporting technology vision aligned with the target budget
- Capturing and clarifying relevant high-level workflows with existing and new systems and applications
- Development of estimates, resource allocation and timelines
- Addressing security and compliance questions
- Assistance in grant application development and answering questions from granting agencies
- Determining and clarifying integration points with EHRs and other systems
- Multi-site studies: Addressing the needs and variability for multiple study sites
- Providing grant-supporting documentation, such as a formal Letter of Support (LoS) and a quote
Study Preparation Stage
This phase starts when funding is granted and the research team begins designing and planning the study. During this phase, as required by the research team, directly or indirectly in just about every activity associated with the preparation of the study. In multi-site studies, we work with sites to understand their capabilities and needs and to develop recipes for application deployment and usage for each type of site.
Depending on the type of the study, availability of ready-made software and components any or all of the following services may be used during this phase.
Services We Provide
- Detailed technical scoping, architecture design and planning
- Working with site IT personnel on provisioning, configuring and deploying necessary technical infrastructure and components
- Addressing compliance and security requirements and producing corresponding documentation
- Development of application and components, integrating with or extending existing applications
- Setting up project documentation, project management, source control, tasks management, communications and testing
- Deployment of new and existing applications and components
- Facilitating analytics and development of supporting manual and automated data extraction processes
Study Execution Phase
This stage begins when researchers are ready to enroll patients and run the study. Activities during this stage typically include:
Services We Provide
- Assistance with patient enrollment
- Conducting sessions and interviews with focus user groups and other study participants
- Collecting and organizing input and feedback from user sessions and interviews
- Development of visuals, UIX mockups, workflow diagrams
- Production deployment of applications and support for them
- “Implementation recipes” development for study sites
- Adjustments and maintenance to the applications and technical infrastructure as needed when running the study
- Application monitoring, usage, activity and error tracking and mitigation
- Data collection and preliminary analytics
- Working with multiple study sites and assisting in successful study execution at these sites
- Addressing enhancements and deficiencies, guiding users and IT teams
Study Completion Phase
Services We Provide
- Data collection and analysis
- Participation in writing research publication
- Post-study documentation
- As needed – rolling back and decommissioning applications and technical infrastructure
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