LumaBridge is a cutting-edge CRO that designs and executes immuno-oncology clinical trials
The LumaBridge difference
For us, science and patient well-being are the central mission—a mission rooted in our founders’ more than 30 years of experience in academic and military research. We act as a strategic development partner, combining academic, scientific, and commercial perspectives to deliver oncology CRO services that exceed expectations.
At LumaBridge, sponsors are paired with one project team to support trial design through execution. Our project teams are responsive and proactive on every trial, and we work with you to advance novel immunotherapies for the benefit of patients.
Flexible clinical trial solutions
Our studies adhere to every regulatory requirement, and our adaptive study designs quickly accommodate sponsor needs and the ever-changing oncology landscape.
We bring specialized experience in oncology to every project and trial, working in sync with our sponsors to achieve study endpoints and development goals.
Clinical and regulatory intelligence
Our extensive experience and understanding of clinical practice guidelines help sponsors pursue suitable target populations and therapeutic areas for their potential therapy. We anticipate regulatory requirements and equip sponsors to work cooperatively with the FDA.
One-of-a-kind medical and regulatory leadership
Under the leadership of founder, CSO, and Executive Chairman Dr. George Peoples, LumaBridge is advancing novel immunotherapies in the fight against cancer. Dr. Peoples is a leading developer of immuno-oncology therapies, including 5 vaccines licensed to industry partners. In addition, our highly trained staff all have extensive experience in oncology.
A large and growing network of leading clinical and research sites
We rely on long-established connections at academic hospitals and prominent cancer centers nationwide to consistently identify motivated investigators and key opinion leaders for studies and to accelerate site selection.
Oncology CRO service capabilities
Expertise in clinical development
Project and Vendor Management
LumaBridge fully supports your company’s outsourced clinical trial model.
- Timeline development
- Milestone management
- Development of study plans
- Project financial analysis
- Third-party vendor contracting and payments
- Third-party vendor management and oversight
Keep your trial running smoothly with our clinical operations experts, which includes a highly qualified group of RNs and CCRP-certified professionals. We manage all the logistics of your trial and ensure constant, collaborative communication to promote your trial’s goals and achieve your milestones.
- Site feasibility and qualification
- Investigator Site File and Trial Master File setup and maintenance
- Study- and site-level IRB submissions
- Site training and initiation
- Monitoring and source document verification
- Site communication and management
- Patient recruitment and retention
- Investigational product accountability
Regulatory Affairs and Strategy
Understanding the critical nature of compliant regulatory submissions—and that quality submissions can accelerate the time to market—our dedicated regulatory team ensures that all deliverables meet regulatory guidance standards. Our FDA-facing regulatory affairs team aspires to have your trial documentation inspection-ready at all times, clearing the path for clinical operations and data management teams to get to work.
- IND preparation, submission, amendments, and maintenance
- Liaising with the FDA
- E-submissions to regulatory authorities
- Strategic support
- Breakthrough designation and fast-track applications
- Target Product Profile development
Clinical Data Management
Clean, compliant, and standardized data are key to a successful trial. Through careful data management, LumaBridge provides you with structured, validated, and meaningful information. Our team is experienced in all phases of data management, from database build through lock, maintaining communication with your team throughout.
- eCRF development
- Database design and configuration
- Data cleaning
- Dictionary coding
- Site training
- Real-time data metrics
- SAE and third-party data reconciliation
- Database archiving
Medical Writing and Biostatistics
We transform your data into meaningful insights. Our skilled, experienced team applies established techniques, delivering accurate, relevant, and informative statistical reports.
- Trial design and schema
- FDA application writing
- Statistical analysis (including ADaM/SDTM datasets and SAS programming)
- Protocol and amendment writing
- Clinical study reports (CSR)
- Investigator brochures
- Informed consent forms
- Annual reports
- Statistical analysis plan
- Journal publication preparation
- Abstract presentation preparation
Medical Monitoring and Pharmacovigilance
Patient safety is the most important concern throughout your trial’s life cycle. That’s why we work with experienced, compassionate, and detail-oriented medical monitors and clinical research professionals.
- Medical monitoring
- Patient eligibility review
- Processing and reporting of SAEs and SAE narratives
- SUSAR determination
- Analysis of similar events (AoSE)
- Integrated summary of safety (ISS)
- Safety database hosting and management
- Independent data monitoring committee set up and management
Assistance for CPRIT applicants
For applicants to the Cancer Prevention and Research Institute of Texas (CPRIT), LumaBridge provides clinical development and commercialization strategies that are more likely to be funded. Our company has an established track record of successfully helping oncology companies obtain CPRIT funding.
Our military background, training, and relationships mean that we have expertise in conducting clinical trials relevant to national security and the US military. We have the experience to navigate the complexities of US military partnerships, and we offer an identical suite of services for government-funded studies as we do for oncology. Dr. Peoples’ years as a staff surgeon at a Level I Trauma Center and his multiple combat deployments are an incredible benefit to those interested in military-relevant technologies.