Let us be a trusted partner in your clinical development efforts.
Acting as an extension of your internal team, we offer end-to-end consulting and services that provide the flexibility to increase and decrease our services based on the timing and phase of your clinical development.
In all phases of development, we will support your study design and execution with a forward-thinking, proactive mindset to ensure timely and continuous progress.
Expertise in:
- In vitro diagnostics (IVDs)
- Laboratory Developed Tests (LDTs)
- Therapeutic/CDx Codevelopment
- Biomarker hypothesis development
- Assay validation
- Software as a Medical Device (SaMD)
- Pharmacodynamic endpoints
- And more...
Therapeutic areas:
- Oncology
- Immuno-oncology
- Rare diseases
- Inflammation
- Infectious disease
Technical Expertise:
- Next Generation Sequencing (NGC)
- cell-free DNA (cfDNA)
- Flow Cytometry
- miRNA
- Immunohistochemistry (IHC)
- Digital image analysis
- To name a few...
All clinical affairs consulting and services can be combined with medical writing activities.
Ready to find out more?
Contact us today with questions or to discuss your project.