We’re here to seamlessly deliver your next trial
Working as an extension of your team, we can offer you:
Scientific and medical expertise
Not only do we know how to work with these complex entities and recognize real or potential impacts on patient well-being, but we also understand the science behind how they work. For example, beyond cell and gene therapies, we’ve also supported advanced and complex therapeutics such as RNA-based therapies (e.g., ASOs, siRNAs), T-cell engagers and genetically modified organisms.
We understand how these unique treatments are developed and manufactured, and how these complex characteristics impact the conduct of a clinical trial including:
- Protocol development
- Long-term follow-up (LTFU)
- Development of companion diagnostics
- Global regulatory requirements for GMO and ATMP products
- Vendor qualification
- Medical monitoring
Global operational solutions
The complexity of these therapies can involve numerous operational challenges defined by the asset in development and reflected in the trial footprint. We offer best practices, solutions and technologies and operational flexibility to optimize the conduct of your clinical trial, including, but not limited to:
- Navigating site selection, activation, and overall study setup
- Defining regulatory and GMO pathways timelines along with approvals
- Assessing Biosafety Level (BSL) accreditation needed to protect workers, the environment, and the public
- Reducing the patient burden for LTFU studies
- Designing and implementing a program’s regulatory strategy, including early engagement (e.g., INTERACT, pre-IND), and when working with rare diseases and pediatrics
Customized training
To ensure your team keeps up with complex and rapidly evolving technologies, we provide comprehensive custom training of all team members. Our Cell and Gene Therapy Team provides targeted, study-specific training, as well as a formal Cell and Gene Therapy Training curriculum.
