our services
Clinical
- IND: Collaborate with Preclinical Development to ensure optimal entry into clinic
- Clinical Proof of Concept (POC): create and execute optimal early development strategy to clinical POC
- Full Clinical Development: Identify and implement optimal path to market considering your corporate priorities
- Commercial Support: Develop and implement Medical Affairs strategy to maximize commercial value of your asset(s)
Operations
- Medical Monitoring
- Hands on Medical/Clinical team leadership
- Data review and analysis
- Clinical Study Protocol design and development
- Regulatory documents (create Medical/Scientific sections of amendments, IB, CSR, DSUR, regulatory meeting documents)
- Matrix and line management of teams and groups
- Vendor Selection and Management: CRO, Clinical Pharmacology, Medical Imaging, Companion Diagnostic, Labs
Corporate
- Corporate strategy
- Investor and Public Relations
- Business Development
- Fundraising
Our approach
Fully customized solutions
We can bring a lot to the table. You may or may not need the full range of our expertise or services. That’s why we start with a conversation, to better understand your needs and
priorities so we can create a solution that makes sense for you.
Flexible mode of operation
We can fully integrate with your organization and fill roles and responsibilities that you need. Or we can support you by completing tasks assigned to us. You choose the optimal
approach.
Scalable resources
We have a network of former colleagues and collaborators who are experts in regulatory affairs, clinical operations, clinical pharmacology, biostatistics, data management, translational research. We know them as people, and we know their expertise. That’s why we can engage them with confidence to support your projects as needed.
Our principals
Iryna Teslenko M.D., MBA
CRO/pharma 19 years
Clinical team leadership 12 years
Academic research 4 years
Vojo Vukovic M.D., PhD
Pharma/biotech 22 years
Chief Medical Officer 12 years
Academic cancer research 8 years
Additional information about us:
- we obtained that experience at Pfizer, GlaxoSmithKline, Johnson & Johnson, Sanofi, as well as more than 10 biotech/biopharma companies and 2 global CROs
- we led hands-on or by oversight more than 200 oncology trials Phase 1-4
- we contributed to approval/commercialization of eight oncology drugs