Question 1

What is Trial Activation Intelligence?

Accepted Answer

Trial Activation Intelligence (TAI) is the intelligence layer that makes clinical trial startup predictable. It spans from protocol finalization to First Patient In, encompassing protocol intelligence, regulatory orchestration, site readiness validation, and predictive activation timelines. TAI compresses the typical 120-day activation timeline to 30-45 days with audit-ready documentation.

Question 2

How much do clinical trial delays cost?

Accepted Answer

Clinical trial activation delays cost sponsors approximately $55,000 per day in direct costs, with enrollment burn rates of $600,000 to $1.2 million per month. The average trial takes 120 days from protocol to First Patient In, with 25-30% of regulatory submissions rejected on first attempt.

Question 3

What is the zero-rejection architecture?

Accepted Answer

NexTrial's zero-rejection architecture validates regulatory packets against jurisdiction-specific requirements before submission, achieving a 94% first-submission approval rate compared to the industry average of 70-75%. Every document is audit-ready with traceable lineage.

Question 4

What regulatory jurisdictions does NexTrial support?

Accepted Answer

NexTrial currently supports FDA (United States), ANVISA (Brazil), and CDSCO (India) with jurisdiction-specific regulatory intelligence. Each jurisdiction has its own Country Blueprint encoding local requirements, documentation standards, and approval pathways.

Question 5

How does NexTrial work with CROs?

Accepted Answer

NexTrial offers white-label Trial Activation Intelligence for CROs. Celina appears as the CRO's own intelligence layer to sponsors — their brand, their client relationship, NexTrial's engine underneath. This protects CRO margins by compressing activation timelines and reducing coordinator burden by 7.5 hours per week.

让中国发起的创新药，可证明地走向全球

申办方

CRO

研究中心及网络

本土速度已解决。下一个瓶颈是全球化。

方案输入 → 准备度输出

方案智能

监管协调

中心准备度

激活

已验证。非承诺。

适用于申办方、CRO 与研究中心

申办方

CRO

研究中心及网络

协调智能。不是另一个仪表板。

其他产品

Celina提供