This case study shows how a global pharmaceutical company used Real-World Data (RWD) to build an External Control Arm (ECA) for a time-sensitive regulatory submission in hematological malignancies. Faced with fragmented data sources, regulatory complexity, and the need for highly segmented comparator cohorts, the company partnered with us to rapidly identify, access, and harmonize patient-level data across Europe. Using our Global Data Partner Network and Trusted Research Environment (TRE), the first harmonized dataset was delivered in only eight weeks, enabling the customer to generate Real-World Evidence (RWE) within the regulatory timeline and establish a scalable model for ongoing cohort expansion.
Key insights
High-quality, GDPR-compliant RWD is essential for building ECAs that meet regulatory standards.
Fragmented data access can create months of delay without a unified, secure infrastructure.
BC Platforms’ network of high-quality patient lives enabled rapid feasibility and sourcing.
Harmonized datasets from five partners were securely delivered into one research environment in just eight weeks.
The collaboration created a repeatable model for ongoing data access, cohort expansion, and future RWE generation.
Why an External Control Arm was needed
A leading pharmaceutical sponsor aimed to use Real-World Data as an External Control Arm in ongoing clinical studies. This required access to multiple high-quality data sources and advanced technological capabilities to generate analysis-ready data for a fast-approaching regulatory submission. The target cohorts in hematological malignancies were highly segmented and required precise alignment with study inclusion criteria.
The data access challenge
For months, the sponsor struggled to access sufficient Real-World Data due to common barriers:
identifying relevant cohorts across multiple geographies
navigating regulatory and governance requirements
consolidating data into a single trusted research environment
Because ECAs must meet strict regulatory expectations, the company needed high-quality, longitudinal, GDPR-compliant patient data. Relevant data existed predominantly across Europe, where the treatment was already used as part of standard of care, but accessing it required advanced privacy frameworks and technology infrastructure.
How we delivered
Rapid feasibility and cohort identification
BC Platforms leveraged its Global Data Partner Network, with more than 16 million high-quality patient lives and longitudinal EMR data, to quickly assess feasibility and identify matching cohorts.
Fast, compliant patient-level data access
We confirmed data availability within weeks and executed all steps required to enable secure access:
contracting with selected data partners
managing ethics approvals
applying advanced harmonization and chart abstraction
consolidating datasets in a single secure research environment
The first harmonized dataset was delivered in only eight weeks.
Impact for the sponsor
Accelerated regulatory timeline
The collaboration bypassed typical RWD access delays, allowing the sponsor to conduct analyses and meet its regulatory filing deadline on time.
A scalable foundation for future studies
With this model in place, the company now continues to collaborate with data partners to increase cohort sizes and build additional real-world evidence for future indications and label expansions.
Strengthen your regulatory strategy with Real-World Evidence
Speak with our team to accelerate access to high-quality RWD and build External Control Arms that support faster, more confident regulatory submissions.
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