Clinical Science & Development
- Review, Analysis, and Interpretation of Clinical Data
- Presentation and Reporting of Clinical Data
- Competitive Intelligence and Literature Reviews
- Development Planning and Strategy
- Protocol Concept, Synopsis and Design
Clinical Program & Project Management
- Functional Team Oversight
- Forecasting, Budgets and Timelines
- Operational Strategic Protocol Design
- Executive Summary Reporting
- CRO Management and Oversight
- Clinical Supplies Management
- Clinical Matrix Team Leadership and Oversight
Medical Affairs
- Strategic Development of Medical Affairs Plans
- Key Opinion Leader Development and Advisory Activities
- Operational Support and Logistics of Medical Affairs Sponsored Studies, Investigator Sponsored Studies, Post Marketing, and Collaborative Studies
Safety & Pharmacovigilance
- Adverse Event and Case Report Management
- Signal Detection, Risk Assessment, and Regulatory Compliance
- Benefit-Risk Evaluation and Risk Management Planning
- Safety Data Review and Aggregate Report Writing
- Safety Database Management and MedDRA Coding
Regulatory & CMC
- Pre-IND, IND, BLA, NDA Applications
- Clinical Regulatory Support
- Reg CMC Support and Development
Medical Writing & QC
- Clinical, Regulatory, QC, Formatting, EU CTR Redaction
- Authoring of Protocols, ICFs, INDs, IBs, CSRs, and Technical Documents
- Technical Document Formatting, Standardization, and Quality Control
Platform and Therapeutic Area Expertise
Oncology (Hemato-Oncology and Solid Tumors)
Hematological Diseases
ADCs and Cell Therapies (Oncology and Non-Oncology)
Infectious Diseases
Cardiovascular Diseases
Rare Diseases
Why Choose Us
We know what it’s like for organizations to struggle to find top talent, carefully placed at the right time. Our flexible team of experts includes advanced-degree and doctorate-level trained scientists, clinicians, operations and support staff across numerous functional areas ready to be deployed to your team when you need them most.
As a small and nimble resource provider, we have built a deep and trusted network within our respective areas of expertise, all who are dedicated to your success. We pride ourselves on being tenacious, aspirational, and focused on making our clients look great.