Evidence Generation Built for Modern Clinical Development

Digital CRO: Real-World Evidence

Applying technology, data, and operational rigor to generate evidence when traditional RCTs aren't an option

Expanding Beyond the Traditional Clinical Trial Models

RCTs are the regulatory gold standard, but they don’t fit every product in every indication. Designing an external control study or fully real-world trial emulation isn’t about shaving the corners off a square peg to fit it into a round hole. The requirements and expertise are unique to real-world data in a regulatory environment.

Our Digital CRO offerings are specific to the unique opportunities and challenges posed by the regulatory use of real-world data as the primary basis for approval and label expansion. When an RCT doesn’t fit, we create the environment that can accommodate your unique needs.

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Built for Today's Data-Driven Drug Development

Today, drug development requires executing models that can adapt to evolving regulatory standards, guidance and expectations. Digital CRO capabilities must meet these challenges head on, maintaining data quality, transparency, and design rigor.

Technology-enabled trial execution

Integrates digital platforms, data flows, and operational processes to meet FDA trial operation requirements.

Designed for flexibility

Supports the needs of the product and indication through external controls, hybrid trials, and fully real-world trial emulations.

Grounded in regulated execution

Aligns trial SOPs with real-world data requirements and fills the gaps for unique real-world data demands.

The Impact of Digital CRO Capabilities

A Digital CRO must meet these challenges head on, maintaining data quality, transparency, and design rigor, but there are added benefits when using real-world data.

Faster Evidence Generation

The duration of an event-driven trial is determined by the differential accumulation of endpoints in control subjects. The larger sample sizes when using real-world external controls allows for the faster accumulation of events, reducing trial time.

Reduced Operational Cost

In addition to reduced follow-up time, there is significant cost savings associated with using real-world controls. The expense of recruitment and primary data collection can be cut by almost half, making these trial designs more cost-effective.

Seamless Coordination

We let all collaborators do what they do best. Traditional CROs can focus on single arm study protocols, recruitment and primary data collection while the Digital CRO focuses demonstrating data are fit-for-purpose, external control/hybrid/trial emulation protocol design and real-world data analyses.

What Keeps Digital CRO Execution Effective

Delivery of a trial utilizing real-world data requires the same executional rigor as a traditional RCT. The overall framework doesn’t change, but the components and the way they’re implemented can be different. Critical to all trials is regulatory transparency and collaboration!

Digital Trial Platforms

Regardless of whether a trial is a traditional RCT or integrates real-world evidence, all aspects must be traceable and auditable. We employ the platforms you’re used to using for maintaining a TMF, eCDT publishing and submission validation.

Data Management

Data integrity is key to any registrational study. Is provenance pristine? Can you conduct source data verification? Have you documented all cleaning and transformations? The end product is the same, but how you get there with real-world data can be unique.

Analytics

Randomization is a tool to balance groups at baseline. What tools do you use to achieve balance with real-world data? The statistical approaches to real-world trials require expanding upon traditional techniques with analytics specific to real-world data sources. It’s not an “or”, it’s an “and.”

Submission Packages

How do you integrate real-world data into a CSR? How do you modify a traditional NDA/BLA/sNDA/sBLA? The goal is for your submission to have a traditional look and feel and to bring that look and feel to the real-world components.

Real-World Regulatory Rigor

There’s no compromising on regulatory rigor. Execute your trials utilizing real-world data with scientific and executional confidence.