The FDA has provided guidance that Phase 3 clinical trials and pivotal studies of new drugs include robust participation from all populations who are intended to use the therapy, particularly those with high incidence of the targeted disease or condition. Beyond compliance, this ensures safety and efficacy across all patient types, increasing physician confidence in prescribing novel treatments and accelerating uptake across all communities. Such broad adoption drives commercial success while expanding access to life-changing therapies, fostering a self-sustaining trust cycle benefiting patients, providers, pharmaceutical and biotech companies, and the healthcare industry overall.
However, achieving truly representative trials has often been seen as complex and resourceintensive—until now.
Inside Edge overcomes this challenge through our Clinical Trial Recruitment services, specializing in engaging populations that have limited access to clinical research, face barriers to healthcare services, and are less engaged in the medical system. Central to our approach is the Trustmaker Network®, including our Community Influencer Cooperative and Independent Pharmacy Partnership. These locally well-known experts help to break down trust barriers and accelerate participation with efficiency. By embedding trusted voices, we deliver faster enrollment, shorter timelines, and better science—enabling clients to bring innovations to market to more people, sooner.
In collaboration with clients and their CROs, Inside Edge and our Trustmakers provide end-to-end support, tailoring our approach to the everyday realities of the patients they are targeting. We clarify misconceptions, increase interest, and ensure the representation necessary for scientific rigor, regulatory approval, and commercial success.
Addressing clinical trial participation gaps
Gaps in specific patient populations in clinical trials restrict pharma and biotech companies’ ability to fully understand and capitalize on scientific, business, and health opportunities.
Offerings
Our comprehensive trial support capabilities ensure that our clients not only have the right plans to meet the FDA’s required protocols, but also have the processes and people in place to execute with ease and achieve their goals.
Planning
- FDA Diversity Action Plan consultation
- Community communications strategy and implementation
- Site evaluation and selection
- Protocol review and recommendations
- Materials evaluation and development
Execution
- Pharma staff and clinical training
- Community education and engagement
- Community pharmacy program
- Clinical site tactical support
- Ongoing enrollment and retention support