A lifeline to better long-term patient data collection
Oovacha helps the life sciences industry engage with patients, build patient registries and generate long-term insights more effectively.
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Minimize Cost
for drug developers and patients
Reduce Burden
on patients, physicians, and clinical operations teams
Unlock Insights
demonstrating the economic and clinical value of medicines
The long acting nature of genetic medicines and the insufficient data around rare disease progression necessitate patient data collection outside of the clinical trial period. But relying on trained clinical sites to collect this data for over a decade can become extremely expensive and onerous.
We are focused on enabling life sciences companies that develop genetic medicines to more easily and more cost-effectively build longitudinal patient registries containing accurate, timely, and comprehensive data.
How it Works
We provide life sciences companies with flexibility, allowing for the collection of patient data beyond the confines of trained clinical sites and across all indications. Our platform accomplishes this through three separate modules, which address the most pressing challenges of longitudinal, non-interventional patient data collection: (1) data harmonization, (2) patient engagement and (3) insight generation.
Data Management
Our data management module allows us to automatically generate high-quality, research-grade data sets directly from raw patient medical records, agnostic of EHR platform or data format. We leverage the latest advances in automation and artificial intelligence to integrate, validate and standardize data buried across clinician notes, lab tests, imaging studies, and patient-reported outcomes instruments.
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Pedestal
Long-term clinical data collection places a heavy burden on patients and their caregivers. Our patient engagement platform, Pedestal, keeps patients engaged through bi-directional communication and data exchange, which not only provides life science companies with patient-reported data, but also provides patients and their caregivers with critical safety information, educational resources and individually curated insights.
Insights
Our analytics and reporting tools allow for visualization of data and seamless export of data to other stakeholders or other software platforms.
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Initiatives We Support
Oovacha’s platform has been designed to support the many use cases of long term patient data which emerge at different points in the company’s life cycle.
Today's Challenge
- Genetic medicines companies are often subject to post-approval regulations, requiring them to conduct long-term follow-up and build patient registries
- Additionally, genetic medicines face significant commercial challenges related to reimbursement and market access. Long-term data becomes critical to justify their high-price tags.
Tomorrow's Solution
- Oovacha’s platform has been designed to capture the data most important to regulators and payers and to minimize patient drop-out during the post-approval period, equipping gene therapy companies with complete and robust data that builds support from regulators and payers
Today's Challenge
- Genetic medicine companies often receive initial regulatory approvals for smaller, more limited populations within the indication their drug is treating.
- Post this initial approval, companies often rely on real world data to support the use of their drug in a broader population, and file subsequent regulatory applications to expand their label for broader populations
Tomorrow's Solution
- Oovacha’s platform has been designed to comply with regulatory guidance around the use of real world data for label expansion and enables the seamless construction of data packages required to support regulatory filings
Today's Challenge
- Prior to commercial approval, life sciences companies may choose to establish broader, more exploratory disease registries to
(1) identify patients who may be appropriate candidates for a specific clinical trial or
(2) compare the disease progression of patients treated with an investigational drug candidate with that of patients who have received a different treatment or no treatment at all
Tomorrow's Solution
- Oovacha’s platform can be used at the earliest phases of drug development and has the flexibility to include patients at any stage of their treatment journey (e.g., pre-treatment or post-phase 1 trials)
Frequently Asked Questions
No, Oovacha's platform is designed to be entirely flexible and configurable to any indication and any set of endpoints.
Oovacha’s platform has been designed to capture the range of data needed to demonstrate the safety, long term efficacy and durability of genetic medicines. The platform can extract data from a variety of sources including unstructured clinician notes, lab reports, imaging studies, NGS reports, and directly from patients themselves. Additionally, the platform can process both human-readable documents (e.g., PDFs and fax) and computer-readable documents (e.g., C-CDA EMR Exports and FHIR)
Oovacha automates the data extraction process using a combination of proprietary data dictionaries, natural-language processing tools and large language models.
All extracted data is evaluated against a range of tests to identify possible data inconsistencies or inaccuracies. Data quality issues which emerge are then manually remediated through our data validation workflow and source data is examined to resolve the issues. Only after successful extraction and validation are data then transformed and standardized using the OMOP common data model. Finally, routine manual checks are then performed on transformed data to provide an additional layer of data validation. Data is only delivered to our life sciences partners once they have passed through the multiple layers of quality checks.
Yes, Oovacha’s platform is fully interoperable. The platform can easily ingest data from other databases and export data in any format, enabling the seamless flow of data into other software products or visualization tools.
Oovacha’s platform has been built according to the highest standards of data security and patient data protection to be compliant with the relevant data and privacy regulations.