COLUMBIA, Md. & NEW CASTLE, Del., Nov. 12, 2025—Advarra, a global leader in regulatory review and clinical research technology, and IgniteData, a specialist in intelligent clinical data automation, announced a strategic partnership to enable secure, automated, vendor-agnostic clinical trial data transfer across research sites. IgniteData’s Archer platform will serve as the connector between site EHR systems, Advarra’s eSource and EDC platforms, and sponsor EDC systems, reducing inefficiencies caused by disconnected data environments and accelerating clinical trial execution across academic medical centers, cancer centers and commercial research sites.
Science Significance
The scientific significance of the partnership lies in its ability to reduce human error and enhance data accuracy, a critical requirement for ensuring clinical validity and reproducibility across therapeutic research. Today’s clinical environments operate across multiple digital systems that lack interoperability, leading to duplicated data entry, transcription errors, and delays that ultimately compromise trial efficiency. By automating structured data flow directly from EHR to EDC, the combined capabilities of Advarra and IgniteData introduce a scalable informatics layer that improves real-time data capture and aligns with ALCOA+ standards for data integrity. The use of an open, flexible connector rather than proprietary single-vendor platforms represents an important scientific and operational step forward in modernizing digital data architecture for multicenter trials.
Regulatory Significance
Regulatorily, this collaboration strengthens compliance with key expectations from agencies such as the FDA, EMA, MHRA, and global ethics boards, all of which increasingly emphasize data integrity, audit trail completeness and electronic-source standards. Advarra’s leadership in IRB and IBC oversight, combined with IgniteData’s regulatory-compliant Archer platform, ensures that automated data transfers remain aligned with 21 CFR Part 11, ICH E6(R3), and modern GCP principles. The partnership reduces risk by minimizing manual transcription, which regulators consistently identify as a major cause of clinical data discrepancies. For investigator-initiated research, the integration supports institutional compliance frameworks by maintaining secure data provenance, ensuring that each data element can be verified from source to submission.
Business Significance
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On the business side, the collaboration enhances operational efficiency for research sites, CROs, and life-sciences sponsors by eliminating costly redundancies. Studies cited by leading oncology institutions note that more than half of clinical trial data is duplicated across systems, with up to 20% of total study budgets consumed by manual data transcription and verification. By leveraging a connector that is compatible with any sponsor-selected EDC, the partnership avoids vendor lock-in and significantly reduces onboarding and infrastructure costs. Advarra’s extensive footprint—used by 90 of the top 125 academic medical centers, 90% of NCI-designated cancer centers, and more than 300 enterprise research sites—positions the partnership to scale commercially with immediate adoption opportunities. For IgniteData, the collaboration accelerates U.S. market penetration and expands deployment of Archer in both corporate and academic environments.
Patients’ Significance
For patients, streamlined digital workflows translate into faster trial activation, shorter data-verification timelines, and improved accuracy of safety and efficacy reporting. Reducing administrative burden enables research teams to allocate more time toward direct patient support, protocol execution and safety monitoring. Automated data transfer also decreases the likelihood of missing or inconsistent clinical information—factors that can impact eligibility assessment, dosing adjustments, or adverse-event interpretation. By accelerating trial conduct, the partnership may help bring new therapies to patients sooner, particularly in oncology, where Advarra and IgniteData already support high-volume, high-complexity research settings.
Policy Significance
At the policy level, the partnership aligns with federal and international initiatives aimed at promoting interoperability, data standardization, and digital modernization in clinical research. Regulatory groups and national cancer networks have long advocated for EHR-to-EDC automation to reduce site burden and improve data reliability. The integration supports public-sector goals around eSource adoption, reducing systemic inefficiencies, and encouraging technology-enabled compliance. It also reflects the larger movement toward open, interoperable ecosystems instead of closed, proprietary research platforms—a direction supported by government agencies and research consortiums striving to increase trial accessibility across diverse healthcare institutions.
The partnership between Advarra and IgniteData marks a significant advancement in clinical research infrastructure, establishing a unified data ecosystem capable of improving accuracy, accelerating workflows, and strengthening regulatory compliance. By enabling seamless, automated data transfer across EHR, eSource, and EDC systems—regardless of vendor—the collaboration offers a transformative model for research sites seeking efficiency and quality in an increasingly complex trial landscape. As development moves forward with early customer partners already engaged, the integration is poised to reshape how modern clinical trials are conducted and how research organizations deliver high-quality, reliable data at scale.
Source: Advarra press release
