Planning
Comprehensive clinical trial planning is essential. A cohesive plan will maximize efficiency and minimize risks in gathering the necessary clinical data to ensure the therapy’s safety and efficacy. The planning process is highly complex, unique, and requires close collaboration.
- Identification of Gene Therapy Ready sites
- Optimize site identification
- Ensure research compliance
- Quality
Gene Therapy Ready Site Network
Research related to gene therapy-based treatments and mRNA-based vaccines is accelerating exponentially. Advarra is registered with the National Institutes of Health (NIH) as the institutional biosafety committee (IBC) of record for 1,500+ research sites vetted and prepared to conduct your next clinical trial.
Watch this video to learn what is an IBC and when is IBC review required.
Optimize Site Identification
Choosing sites with the right patient population, infrastructure, and experience is essential for a successful trial. But consolidating and evaluating various site lists and distributing and responding to site feasibility questionnaires is time-consuming for both study teams and research sites.
Surveying sites in a centralized manner — versus fragmented processes like emails and other portal(s) — enables sponsors and contract research organizations (CROs) to monitor and store real-time response rates and survey results while minimizing burden and redundant data requests of sites. Advarra’s Study Startup solution enables sponsors and CROs to gather critical information about potential site partners with a workflow tool combining multiple site lists, routing for review/approval, and tracking site status.
Ensure Research Compliance
Research compliance is an ongoing commitment. It is the cornerstone of ethical research practices. Our team of experts works with you to navigate the various regulations and guidelines from governing bodies in an evolving and complex regulatory landscape.
Make Quality Your Competitive Advantage
Advarra provides industry-leading, end-to-end GxP quality solutions for the rapidly changing life sciences industry. As value chains extend around the globe and regulations evolve, the need to maintain and optimize all aspects of quality management systems has become more critical.
