Evidence Central

Together we can unlock the potential of real world evidence and support the advancement of therapeutic discoveries

Patient Centricity

We designed our solutions with the patient’s voice in mind and with the goal of reducing healthcare disparities. Our patient portal simplifies onboarding processes, is geographically inclusive, supports racial and ethnic diversity, and is flexible and adaptive. In addition, it helps you create communication strategies that represent your community.

Clinical Trial and Research Continuum

Our platform, healthie™, is agile by design and enables organizations to evolve their projects as analysis of evidence suggests, for example, when study protocols are changed, new participants recruited, new data variables added, and when new endpoints are discovered.

Data Sharing

healthie™ supports advanced analytics and reporting. Our platform enables data sharing across boundaries, accelerating the possibilities of identifying commonalities across diseases or therapies. Of course, data sharing between patients, researchers, clinicians, and industry are all conducted with a transparent governance structure in place while ensuring data privacy and security.

Drug Discovery Central

Our globally deployed evidence generation platform enables us to rapidly scale and integrate multiple datasets and data sources, even as regulations evolve. The collective evidence that can be generated from our healthie™ platform can be leveraged for the purpose of, but not limited to:

  • Supporting decentralized clinical trials and studies
  • Understanding the burden of disease
  • Developing treatments and guidelines
  • Developing of biomarkers and endpoints
  • Leveraging natural history as comparator arm to facilitate new drug development/clinical trials
  • Supporting hypothesis generation and publications
  • Supporting health economics and outcomes research

Generating Evidence for Your Research

healthie™ manages disparate, complex data using a multi-tenant architecture designed to promote global alliances. Our platform and modules are designed to maximize workflow and serve as a single system that you can use to promote patient engagement, conduct natural history and disease-specific studies as well as support onsite and/or decentralized clinical trials. The modules can be combined to create a platform best suited for your initiatives.

Your patient community’s data is secure and compliant with healthie™.

healthie platform diagram

Meeting Your Privacy and Security Requirements

healthie™ is an AWS cloud computing platform as well as a communication hub that is GDPR, HIPAA, and FDA 21 CFR Part 11 compliant.

Structured Data Support

We create a standardized glossary of terms for your registry that is used wherever data is collected. This ensures that all of your data is structured the same way across all participants/users and sites, reducing user error and making it easier to analyze.

Mapped to OMOP & CDISC

These standards are recognized by the FDA and EMA for regulatory approval. The Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) establishes standardized data structures for visits/encounters, procedures, medications, observations, patients, providers, and other information. The Clinical Data Interchange Standards Consortium (CDISC) is a standards developing organization that manages data sharing between medical research data and healthcare. This can improve medical research and related areas of healthcare.

Data Visualization and Insights

A successful evidence-based platform cannot be built without understanding what all collaborators need to know to further rare disease research. To that end, our evidence generation platform is configured to capture the relevant information to support your data requirements. The platform also provides insights into complex data that are analyzed and rendered into easy-to-understand visual displays.

Insight Services

At Pulse Infoframe, we recognize it takes a comprehensive approach to design, deploy and maintain a sustainable and effective patient registry.  It requires a team of multi-disciplinary experts to deliver a product and solutions platform that supports collaborative network(s) and addresses the clinical, data, and system requirements for the different stakeholders involved with the registry.

The Pulse Infoframe process commences with:

  • Development of a feasibility study workplan, which is milestone based and includes individual and workgroup questions
  • Formation and maintenance of a governance body, including key opinion leaders (KOL), steering committee, board, and workgroup to establish industry-recognized protocols, methodologies, and statistical analyses
  • Delivering expertise and guidance to country-specific regulatory and site-specific ethical requirements
  • Providing access to an experienced team of scientists and epidemiologists throughout the engagement from feasibility study, registry configuration, and maintenance to offer scientific advice where needed

Our Insight Service offerings include:

Discover

Our team of experts will work with your key opinion leaders to understand, define, and prioritize your clinical, protocol, data, and regulatory requirements to determine the right solution for your organization.

Design

Guided by your requirements and use cases and our experience, our team will design a solution for you that is sustainable and will scale based on evolving clinical, business, and strategic objectives.

Deliver

Once the solution design is complete, our team will configure, ready, and deliver the target solution quickly and efficiently.

Decision

We provide the expertise and experience to implement governance structures, support publication approvals by SAB, and assist study research groups with data collection and statistical analysis, where required.

Are you ready to start your journey?