Advanced real world data is needed for rare diseases and validated studies
Graticule focuses on advanced data sources such as clinical notes, images and non clinical data needed for translation into clinical use, research at scale, safety surveillance, regulatory approvals, and reimbursement
Graticule Solution Offerings
Graticule Odyssey Map
Rare Disease Natural History
There are 5,000 – 8,000 identified rare diseases today. Diagnosis is often complicated ranging from 5 to 7 years. In these cases, organizations need to understand the natural history of rare disease patients and generate insights to identify at-risk patients and understand disease progression to find intervention opportunities to prevent long term consequences of the disease.
Key Features of Graticule Odyssey Map Solutions:
- Generate insights for disease progression, gaps in diagnosis, patient journey and treatment response using longitudinal data
- Identify indicators and biomarkers
- Potential linking with imaging and pathology data for deeper understanding
- Aid in protocol development, study execution, KOL engagement and analysis of datasets for the study
Graticule Patient Finder
Rare disease presents challenges with regards to identifying patients for clinical trials or for treatment. Very often the understanding of rare diseases is limited, thereby hindering identification and treatment approaches, even after a therapy has been approved. The Patient Finder offers solutions to build algorithms for patient identification and deploy within health systems to identify and recruit patients for clinical trials and commercial purposes.
Key Features of Graticule Patient Finder Solutions:
- Generation of disease specific subsets from longitudinal data to create accurate identification tools
- Expertise for the development, training and validation of patient identification algorithms
- Scale algorithm within health systems to be applicable at clinical point-of care
Graticule Launch Compass
Pre-Market Evidence Dossier
Studies to identify pre-market evidence and insights for a drug approaching FDA approval and requiring evidence to support reimbursement. Evaluate the burden of a disease on the patient’s quality of life, work productivity, healthcare utilization, and costs.
Key Features of Graticule Launch Compass Solutions:
- Evaluate impact of disease on patient quality of life, work productivity, healthcare utilization, costs and full burden of disease beyond healthcare utilization
- Help position drug through evidence generated from linked datasets
- Establish value-based arguments for drug reimbursements
Graticule Therapy Uplift
Studies to determine treatment patterns and adoption of a new drug in the market. Identify segments of patients and prescribing patterns to improve messaging, targeting and awareness for adoption of the medication.
Key Features of Graticule Therapy Uplift Solutions:
- Generate insights for clinical, demographic and/or provider characteristics influencing prescribing patterns
- Understand the unmet need, evaluate events leading to prescribing and treatment outcomes, and identify multiple continuing patterns of a drug over time
- Stratify and identify patient segments who can benefit from the treatment before the drug is approved
Graticule Safety Watch
Medical Device Safety
Regulators such as EMA and FDA are increasing requirements for surveillance for medical devices. Studies to understand the patient care from a device perspective requires linkage of device ID and downstream medical outcomes. Safety Watch uses data from IBM Explorys Therapeutic Datasets containing device information to help companies support compliance.
Key Features of Graticule Safety Watch Solutions:
- Access to outcome data relating to adverse events and device information for showing effectiveness and safety of medical devices
- Link clinical, claims and imaging data to derive insights for clinical end points/outcomes, device safety, effectiveness through readmissions and post-surgery conditions
- Address pharma business need for minimum viable product pertaining to radiology
Graticule Case Extract
Synthetic control, label expansion, and biomarker development data
Randomized controlled trials are costly, time consuming, and offer limited benefit to placebo arm participants who may have life threatening diseases. Many approved treatments are already being tested in open label prescribing that can be leveraged for regulatory expansion such as approvals to treat additional tumor types. Graticule sources regulatory grade patient cases with advanced clinical elements including features from free text clinical notes, radiology data such as original PET-CT image files, pathology results, and survival data to meet stringent FDA and EMA submission requirements for product review. Prior Case Extract study examples include training and validation data for a machine learning algorithm that predicts response to Immuno-Oncology (I/O) therapy and standard of care controls in a rare disease trial.
Key Features of Graticule Case Extract Solutions:
- Lower volumes of patients need to be recruited into clinical trials leading to faster time to market and reduced development spend to achieve regulatory approval
- Geographic diversity for regulatory grade RWE studies including Europe, US, and Asia
- Trusted relationships and rapid contracting models with health technology providers and health systems
- Data extraction tools from back-end systems such as PACS and EHRs, NLP and data quality tools to normalize and cleanse records
- Clinical research associates to curate data of interest into Case Report Forms (CRFs)
- De-identification of patient records that preserves longitudinal relationships or enables linkage across independent data sets
Opportunity: Accelerate research studies that would be too slow or unfeasible to execute without rapid access to relevant Real World Data.
Solution: Curated advanced data sets that extend existing data by including radiology images, unstructured notes, archived medical records, consumer behavior, and genomics. Graticule’s advanced Real World Data access offers multiple applications for Life Sciences including label expansion, drug re-positioning, acceleration of regulatory approvals, biomarker discovery and validation, early disease detection, rare disease identification and epidemiological studies.
Opportunity: Medical device manufacturers are facing increasing, time-sensitive regulatory pressures in the European Union with expected changes in the US. Products will be excluded from markets without rapid action to meet these guidelines. Furthermore medical devices are increasingly becoming dependent on health information technology without visibility into medical practice including robotic surgery and remote monitoring applications.
Solution: Network of leading health system partners with device registries and extended patient data from EHR records can address imminent post market-surveillance requirements. This data can be extended to support biomarker discovery and algorithm training for product enhancements in the growing robotic surgery, drug-implant combinations, and connected device markets.
Artificial Intelligence and Diagnostics Companies
Opportunity: Artificial Intelligence companies often require geographic, and demographic diversity as well as observational data to enable model training, validation and regulatory approvals. Machine learning models require elements from unstructured free text data and data from multiple different modalities that are often difficult to acquire in order to establish predictive models with accuracy levels sufficient for approval, reimbursement, and use.
Solution: Our global health system partner network enables access to advanced datasets such as radiology images and unstructured notes from geographically and demographically diverse populations to support development and regulatory validation of AI algorithms.
Opportunity: Health systems have limited budgets to apply to data and analytics that could help diagnose and treat patients more effectively. Building a Real World Data Enterprise enables collaboration with industry partners to provide needed outside funding and expertise to improve data quality and to test new tools for patient care. Sponsors can support large scale research studies across sites, execute follow-on clinical trials, and build novel algorithms to identify rare diseases or treatment candidates.
Solution: Graticule works closely with research sponsors and AI companies with a continuously growing portfolio of opportunities. We partner with existing Health Information Technology infrastructure to leverage existing investments. Our research utilities and expert resources solve for de-identification, governance, and curation challenges. The impact is increased Real World Data and clinical trial studies, new algorithms to reduce the diagnostic odyssey for patients with treatable rare diseases, and a more mature analytic environment for patient care. Our integrated and collaborative approach can enable information opportunities to translate quickly into better care.