| Key Results | ||
|---|---|---|
| >50% | >30 | 3 Client Teams |
| Reduction in clinical trial agreement cycle times | Country-specific contract regimes harmonized | Aligned through the project (Legal, Study Start-up and Clinical Development) |
A publicly traded global biotechnology company, with more than 3,000 employees, over $2 billion in annual revenue and market cap exceeding $30 billion, was expanding its pipeline of cancer medicines and rapidly increasing its global clinical trials. However, its legal operating model for study start-up fell well below target lead times and struggled to scale internationally. Without major improvements, the company risked delays that could hinder clinical progress and business growth.
We launched a multi-phase engagement to develop a scalable legal operating model. First, we gathered insights through surveys, interviews, document reviews and data analysis to identify process bottlenecks and improvement opportunities.
Next, we created region and country-specific clinical trial agreement templates and playbooks, covering standard positions, fallbacks, rationale, escalation protocols and clause libraries. We assessed the client’s contracting resources to ensure they could effectively use these new tools.
In later phases, we deployed a team of subject-matter experts to manage clinical trial negotiations using the new templates and also supported an emergency privacy remediation project. We then established a managed services team to negotiate clinical trial agreements across more than 30 countries while training the client’s staff to use the new artifacts.
Finally, we led a remediation effort to ensure over 600 contracts complied with Schrems II privacy requirements and developed a repeatable process for ongoing compliance.
Outcome
The client achieved its global contracting standard for clinical trials, aligned legal and study start-up teams and reduced contracting cycle times by more than 50 percent. The scalable model now supports continued growth and faster site start-up.
Facing similar clinical trial contracting challenges?
We can help you develop scalable, efficient legal operating models that accelerate clinical progress.
* This project was delivered while supporting a previous organization.