Takeover of lifecycle maintenance of investigational new drug applications

A Tier 3 Sponsor with active clinical investigations and multiple active, existing Investigational New Drug Applications (INDs) was unhappy with their current vendor’s support. The Sponsor selected Certara as its new vendor for Lifecycle Maintenance (LCM) of their INDs. It was important to the Sponsor team that they received better responsiveness and minimal disruption of activities during transition in the new partnership.

解决方案

监管审批

Products

GlobalSubmit™ eCTD 软件

Certara was able to leverage technology to facilitate the smooth transition. We ensured a quick setup of the new software environment for the Sponsor’s applications and a quick import of the Sponsor’s existing sequences via our GlobalSubmit™ REVIEW . The Certara team was ready to assume publishing of the Sponsor’s sequences within days of the signed contract. The smooth onboarding process consisted of Certara assigning dedicated points of contact and delivering an onboarding/orientation presentation via a project kickoff meeting.

The Sponsor even began using our GlobalSubmit™ REVIEW  software with minimal training and no local install required (the Sponsor’s Information Technology team was happy!). The Sponsor was overall delighted by the smooth onboarding experience and engagement by the Certara  team and immediately benefitted from our industry-leading turnaround times for routine IND submissions.

The Certara team was ready to assume publishing of the Sponsor’s sequences within days of the signed contract. The Sponsor was overall delighted by the smooth onboarding experience and engagement by the Certara  team and immediately benefitted from our industry-leading turnaround times for routine IND submissions.

Certara ’s team of Regulatory Operations specialists ensures a smooth transition and completion of your submission, no matter where it is in the cycle or where it is coming from.