MotilityCount ApS Launched Their Clinical Study in Just One Week with Harbor

Traditional EDC vendors often force clinical sponsors into lengthy, rigid build timelines and hefty price tags, delaying life-changing science. To bypass these bottlenecks, NOVA Genomics and MotilityCount ApS worked with Harbor to launch a 1,600-patient study in just nine days.

The Metrics

• Protocol hand-off to live EDC: 9 days
• EDC build times quoted from other vendors: 10–12 weeks
• Flat fee for EDC build: $2,000

The Challenge

MotilityCount ApS is the sponsor of a clinical study evaluating high-precision preimplantation genetic testing (PGT) for IVF patients. NOVA Genomics, a genetic testing provider focused on delivering clinically meaningful PGT insights, performed the diligence and arranged for the EDC component of the study. When the team went looking for an EDC vendor, they hit a wall.

"We were staring down 10-to-12-week timelines and hefty price tags from every other vendor we talked to. Harbor delivered a fully validated EDC in nine days at a fraction of the cost. It was refreshingly simple; no drawn-out scoping calls, no surprise fees. I'd highly recommend them to anyone planning to run a clinical study."

— Cynthia Hudson (CEO, NOVA Genomics)

The Solution

Harbor reached out to the NOVA Genomics team at exactly the right moment and made a promise: the study could be fully set up and live within one week. Using Harbor's Magic Build feature, the team uploaded the study protocol and automatically generated a first pass of electronic case report forms (eCRFs) in minutes. After one pass of UAT with NOVA Genomics, the EDC build, including randomization configuration, was live in production just nine days after the protocol was handed over. Additionally, Harbor includes a pre-built validation package (requirements, risk assessment, and traceability matrix) so teams don't have to generate these documents from scratch.

The Result

The study, NCT07369362, is now live and actively enrolling subjects across an anticipated 15–25 centers worldwide. Ultimately, the study will reach about 1,600 couples going through IVF therapy.

In clinical trials, weeks of delay don't just cost money — they delay potentially life-changing insights from reaching patients. Because the database was ready in nine days, enrollment could begin immediately after site activation instead of waiting another 2–3 months for an EDC build.

Don't let software delays slow down your science.

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