Our Expertise
Four connected service areas. One multidisciplinary team. Delivered across biomedical, federal, and community settings, and around the world.
Health, Regulatory & Safety
For biopharmaceutical sponsors, federal health programs, and research organizations, DRA delivers director-level expertise across the clinical and regulatory lifecycle, drawn from a career at the leading edge of industry R&D and federal health research.
We bring risk-based compliance strategies, regulatory rigor, and scientific integrity to clinical trial operations, drug safety, and quality, aligned with FDA, HHS, NIH, and DoD standards.
Clinical operations
- Clinical trial operations & oversight
- Risk-based monitoring frameworks
- Investigator & site audit / inspection readiness training
- Data management, analysis & reporting oversight
Drug safety & pharmacovigilance
- Pharmacovigilance operations setup
- Aggregate safety reporting
- Medical safety review
- Signal evaluation & pharmacoepidemiology
Regulatory & quality
- Regulatory support & submissions (FDA, EMA & other authorities)
- Quality assurance & audit readiness
- Vendor oversight
- Compliance aligned with FDA, HHS, NIH & DoD standards
Evidence & monitoring
- Real-world evidence & post-market surveillance
- Risk-based compliance strategies
- Purpose-built digital solutions
- Reporting, analytics & oversight
Research, Evidence & Evaluation
We help organizations generate, interpret, and act on evidence. Our research and evaluation support spans health, behavioral, and social science settings, and we bring modern data and AI tools to bear where they add value.
- Research support and study design across health, behavioral & social science domains
- Monitoring and evaluation, metrics, and reporting
- Data analysis and real-world evidence
- Feasibility and assessment studies
- Technical writing and translation of complex findings into actionable insight
- AI and digital solutions for research and healthcare, including analytics of complex and unstructured data
Strategic Program Management & Coordination
We bring structure and momentum to complex programs. Whether you need day-to-day administrative and project support or end-to-end program oversight, we help initiatives stay coordinated, accountable, and focused on outcomes, across any sector.
- Program and project management for health, research & development initiatives
- Administrative, logistical, and operational project support across sectors
- Strategic planning, organizational development & start-up support
- Workflow design, process improvement & SOP development
- Coordination across funders, partners, vendors & stakeholders
- Workforce planning and capacity building
Community & International Development
Beyond biomedical settings, DRA extends its research and program support to global development and community-focused initiatives, prioritizing solutions to health disparities. For more than three decades, our founder has worked as a community organizer and global development strategist across the US, Africa, and the Caribbean.
- Community organizing, mobilization & stakeholder engagement
- Advocacy, policy & legislative outreach
- Locally-led development frameworks & local systems strengthening
- Economic development with local government, NGOs & donors
- Feasibility studies & program assessment
- Monitoring & evaluation aligned to the SDGs
How we engage
Structured to fit the client.
Project & Program Contracts
Fixed-scope or ongoing engagements for government, nonprofit, academic, international, and private-sector clients.
Advisory & Retainer Support
Ongoing senior advisory support for organizations building capacity, preparing programs, or navigating complex initiatives.
Training & Capacity Building
Workshops, sessions for global partners, and trainings that build lasting skills within your team or community.
Let's talk
Not sure where your program fits?
Tell us what you are working on, and we will tell you honestly whether and how we can help. Your first 30-minute consultation is free.