External vendors now supply more than 70% of study data, from central labs and omics to PK and ECG. Each of these non-EDC sources brings its own format and delivery timeline. That variety makes external data hard to manage and easy to get wrong. External Data Accelerator from Certara applies speed and quality to the data deluge by pairing Certara’s external data management services with Pinnacle 21 Data Exchange. Our tech-enabled team embeds standards and validation from day one, so your data lands clean, and your study moves toward submission readiness—not last-minute issue correction.
External Data Accelerator
Your standards-first team and technology for conformant vendor data
Learn more about External Data Accelerator
One team, one set of standards for external data management, from setup to submission
Standards from the start
Certara’s expert biostatistics consulting team works with your data vendors to author unambiguous and standards-aligned transfer specs, so data arrives with a clear path to their CDISC dataset.
Real-time, automatic validation
Our consultants configure Data Exchange to validate every file your vendors upload against these transfer specs immediately, with all issues flagged instead of surfacing weeks later. Data Exchange also routes clean files to your desired database.
Issue intelligence
Identify success and error trends over time by data source, issue, and vendor. Our dashboard fosters continuous improvement.
External data management designed to work with your team
External Data Accelerator augments your existing standards and data management workflows. For sponsors still building out their processes, we provide a repeatable framework for data collection across all your studies. Emerging biotechs can count on a turnkey approach even in the absence of an internal infrastructure. We also work hand in hand with CROs.
The technology for cleaner transfers
Centralized data transfer specifications
Our services team works with your data vendors to write clear, structured transfer specs for every incoming data type. Aligned to your standards, the study context, and downstream reporting, the specs are visible to all stakeholders on Data Exchange, not hidden away on a spreadsheet.
Real-time, automatic validation and delivery
Data Exchange is configured to validate incoming files (lab, PK, imaging, ECG, and other non-EDC data) against your transfer specs automatically upon upload from each vendor, flagging every issue right away. Data Exchange delivers files to your preferred repository.
Monitor sources of error over time
A dashboard lets your team monitor transfer speed and data quality by study, vendor, and rule as it happens. Spot the roots of common issues and hold stakeholders accountable.
为何选择 Certara
Certara is the only partner that combines the validation platform FDA and PMDA use internally with the biometrics expertise to build to it. That means fewer data crises during your study, and a faster path to submission-ready data at the end of it.
Leading integrated technology
Pinnacle 21 is the same validation software used internally by FDA and PMDA to review incoming submissions. Data Exchange governs specifications, metadata, transfer validation, and data quality visibility, all in one environment.
Delivery expertise
External data management teams build to the standard, not just consult on it. Certara specialists bring hands-on experience in external data management, CDISC standards, PK, and biomarker data, along with submission preparation, directly into the study startup process.
Regulatory trust
Decades of hands-on FDA, EMA, and PMDA submission experience inform every deliverable.
认识我们的专家团队
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专家
Tiffany Woodworth
Senior Vice President, Integrated Evidence Based Solutions
Tiffany has 19 years’ leadership experience in biometrics, data science and statistical programming in the Life Sciences industry. She leads Certara’s PK/PD programming, biostatistics and analytics teams that build and validate external vendor data, and previously served as President and GM of Panalgo, driving significant revenue gro...
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专家
Erin Erginer
Senior Director of Product, Certara’s Pinnacle 21
具有 20 年临床研究和医疗保健经验的创新领导者，专注于临床生物样本和数字化健康评估数据的获取、管理和转换。为制药行业提供技术化解决方案的协作创造者。多才多艺的分析总监，具有良好的人际交往和沟通能力，并具有在战略和战术层面上管理多职能团队的经验。...
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Partnering with Certara means a cleaner path for external data from the start of your study, backed by the standards regulators trust.
Senior external-data management expertise
Decades of hands-on FDA, EMA, and PMDA submission experience
A study foundation aligned to CDISC from day one
常见问题解答
What is the External Data Accelerator?
It pairs Pinnacle 21® Data Exchange with Certara’s external data management experts to prepare specifications, standards, and validation for external vendor data before data begins flowing at scale.
What data does it cover?
External sources, non-EDC data such as central and specialty labs, imaging, ECG, and PK data — where late data, reconciliation, and vendor coordination problems most often emerge.
How is this different from a typical EDC build or data management engagement?
Most EDC builds and clinical data management services run independently of your submission standards, which get reconciled later. The Accelerator builds directly inside Pinnacle 21, so the same standards, metadata, and validation rules carry through from setup to submission without a separate reconciliation phase.
How is it different from licensing the software alone?
Data Exchange provides the platform; the accelerator adds Certara specialists who build the specs, run validation, and manage vendors. Saving you on internal lift. Certara configures/specifies/supports validation and issue workflows, while the sponsor/CRO/vendor still owns the agreed operational responsibilities.
