Real-World Data Opportunities

As reflected in the 21st Century Cures Act and guidance from the FDA's Real-World Evidence Program, real- world data (RWD) and evidence (RWE) are increasingly being used and sought for supporting safety and effectiveness decision making.

The use of RWD and RWE enhances our ability to modernize clinical research and bring safe and effective therapies to patients more efficiently.

RWE studies can complement randomized control trials (RCTs) and contribute to a robust evidence package to support regulatory decision-making

Using RWE is more representative of the impact of a medical product, including routine clinical care and self-care

RWE captures the evolving standard of care, whereas RCTs capture information during a specific timeframe

Moving forward, RWD is likely to play an even larger role in assessing benefits and risks for medical products that receive accelerated approval or in diverse patients who were not included in pivotal clinical trials

Integrated evidence generation at OM1

At OM1, we approach RWD and RWE differently. We can quickly, accurately and cost-effectively deliver more powerful RWD to meet emerging needs. To do this, we:

Leverage multi-source, linked clinical data on hundreds of millions of patients
Use AI technologies for tech-enabled abstraction and predictive modeling
Link to specialized networks to fill in data gaps and increase validation
Collect PROs, claims, and additional variables
Use auditable RWD to support regulatory decision-making

Meet OM1 Aspen

At OM1, we’re changing the research paradigm to enable rapid, cost-effective, and scalable research. OM1 Aspen enables life sciences organizations to automate real-world data collection and grow evergreen data networks, resulting in faster times to study launch, more complete and reliable data, and lower costs. » Learn more

Automated study platform for registries and real-world evidence generation

OM1 Aspen leverages our proprietary data sourcing, processing and enrichment technologies, including electronic medical records harmonization, image management, advanced medical text processing and linkage, to deliver a more efficient, cost-effective and scalable approach to research.

With OM1 Aspen, life sciences teams can tap into our networks or build new ones for automated evidence generation, harness scientifically robust data from large and diverse populations, and gain depth around patient outcomes with linked data.

Traditional methods deliver the same results and limitations.

Linear, rigid design
Costly and long delays to insights
Selection bias and lack of diversity
Extensive use of manual processes that are burdensome for HCPs and patients
Gaps in data

Automation changes everything.

Flexible, reusable design
Continuous stream of RWD
Accelerate study timelines and drastically reduce costs
Easily recruit high volumes of patients and minimize burden to sites and patients
Increase patient diversity and reduce bias
Linked data with the ability to adapt and expand

How OM1 helps life sciences organizations

1. Achieve unparalleled cost and time savings

Faster, more reliable, and lower costs

OM1 Aspen dramatically improves cost efficiency, timelines, and breadth of data collection for sponsors.

Technology enabled real-world data accelerates research

OM1’s network-based technology connects patients and providers to build a reusable, adaptable system that will have faster and more positive repercussions on standard of care.

Cutting-edge life science companies are leveraging RWE across the enterprise to unlock value and accelerate research, again and again.

$300 million

Per year in estimated savings for the average top 20 pharma company after adopting advanced RWE analytics across the whole value chain¹

$10-40 million

Per year in average spend by pharmaceutical companies on third-party data/data solutions, most often for single-use initiatives²

How OM1 helps life sciences organizations

2. Improve patient retention, recruitment and population diversity

Find the right sites and patients

OM1 helps sponsors identify the right sites, find under and undiagnosed patients, target the locations where those patients are clustered, and identify catchment areas for socioeconomically diverse populations in ways previously not possible.

Reduce burden and increase follow-up

By automating data collection and systemizing data mapping and harmonization, we can achieve much greater efficiency, reduce site and patient burden, and increase patient numbers and follow-up over traditional data collection for research studies.

Enhance diversity

With wider site participation and broader patient populations, results are more generalizable and individualized.

How OM1 helps life sciences organizations

3. Bridge evidence gaps

Direct and linked data fill in the gaps

Bridge the insight gap by analyzing, disseminating, and communicating real-world insights that optimize experiences for patients and physicians.

Capture the patient voice

Prospective PRO collection has been limited to date. OM1 further enhances RWE with prospective PRO data, providing information on quality of life, effectiveness, tolerability, and safety from the patient perspective.

Demonstrate patient value in real-world settings

Bridge the insight gap. Analyze, disseminate, and communicate real-world insights to optimize experiences for patients and physicians.

Automated and network-based evidence generation solutions add value across the product lifecycle

Lifecycle Management

Make more informed decisions on your product. Gain evidence into how your drugs are being used and their effectiveness in real-world settings and drive future business success.

Launch & Commercialization

Gain insights into patient populations, optimize drug development and marketing strategies, and support regulatory and reimbursement decisions.

Clinical Trials Phase 2 & 3

Accelerate patient recruitment, identify endpoint and comparator selections, explore feasibility, and generate supplementary evidence.

Registries, Safety, & Long-Term Follow-up

Meet post-marketing commitments, optimize safety surveillance and long-term follow-up, explore natural history of disease, and evaluate real-world effectiveness.

A reusable solution that grows with your needs

OM1 Aspen provides an innovative approach to collect data, generate evidence, and meet stakeholder needs in a reusable way. Once deployed, studies and engagement are easy to activate and adapt as needed and provide an ongoing source of prospective data.

OM1 Aspen helps teams across the organization reach their research goals faster and more efficiently.

Clinical Operations
Safety & Regulatory
Medical Affairs
Epidemiology & RWE
HEOR
Commercial
Data Enterprise & Strategy