Certara tackles clinical data headaches with early standards checks

By Elena MacLeod · September 18, 2026, 11:15 PM · Updated: September 20, 2026, 8:54 PM · 3 mins read

Certara is betting that catching data standard problems at the source can save clinical trial sponsors months of costly remediation and regulatory headaches.

When a clinical trial sponsor finds a data standards problem at the submission stage, the fallout is messy: renegotiating with vendors, reprocessing datasets, and racing to meet regulatory deadlines. Certara wants to change that with its External Data Accelerator, a service built to spot and fix standards issues before they ever reach the study database.

The scale of the problem is hard to ignore. Certara’s analysis shows that over 70% of clinical study data now comes from outside vendors, each using its own file formats and delivery schedules. Most studies pull from at least four different sources—biomarkers, labs, imaging, ePRO platforms, and wearables—making it easy for mismatches to slip through, especially as CDISC standards keep evolving.

The FDA continues to support SDTM as a core standard for regulatory data submissions, alongside other evolving formats, according to the CBER-CDER Data Standards Program Action Plan.
FDA

Certara’s new service pairs senior external data specialists with the Pinnacle 21 Data Exchange, the same validation engine the FDA has used for years. The idea is to check incoming vendor data against CDISC standards as soon as it arrives, not just before a regulatory filing. If a vendor file fails a conformance rule early, it can be fixed in days. If the same issue turns up during submission review, the fix can take months.

The timing matters. By 2026, three CDISC standards will overlap, with a public review period for SENDIG v4.0 with Rules and SDTM v3.0 running through November. Sponsors juggling multiple external data streams during this transition face a fragmented vendor landscape and a version-control headache as standards shift mid-study. According to the CBER-CDER Data Standards Program Action Plan, the FDA is updating its data standards program to handle multiple formats and will keep supporting SDTM, which remains a core requirement for submissions.

Certara is pushing for standards conformance to be a design decision made at study setup, not a last-minute scramble. The real test will be whether their teams can enforce vendor data agreements early enough to shape what vendors actually deliver. Success will show up if submission packages built this way clear FDA technical rejection rates faster than the industry average.

USDM v4.0, released in June 2025, is now part of the current CDISC standards stack, and its documentation and conformance rules are essential for sponsors navigating evolving regulatory requirements.
Kitsa.aiIndustry Analysis

Certara’s External Data Accelerator is a direct response to the operational headaches that have frustrated clinical trial sponsors for years. By moving standards enforcement upstream, the company is betting that early intervention will mean fewer regulatory surprises and less wasted reviewer time. If Certara’s approach works, it could change how sponsors handle the growing complexity of external clinical data as standards keep shifting.

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Elena MacLeod

Elena MacLeod is Clinical Biotechnology Editor at GenoMethods, covering CAR-T, engineered cell therapies, gene therapy, clinical trials, cancer immunology and regulatory developments. Her evidence-first reporting focuses on trial design, patient populations, safety, efficacy, response durability and the limitations that determine how early clinical results should be interpreted.