Lambda Therapeutic Research Sp. z o.o. offers you integrated package of services for early phase of the project. Our approach, focused on close cooperation with the Sponsor, merge efficient patients' recruitment, cost-effectiveness of projects with high quality of data. From pilot studies to big phase I projects, we can offer you comprehensive services to meet your phase I development needs.
Phase I services
- Local Project Management
- Protocol development / review
- CRF design / review
- Subject Information & Informed Consent Form preparation / review
- Investigator selection / contract negotiation
- Help with obtaining IEC approval
- Help with obtaining Regulatory approval
- Rapid recruitment and screening procedures
- Medicinal Product handling: storage in dedicated, limited access Investigational Product (IP) room / drug accountability
- Diet planning and control (diet standardization, diet preparation according to specific study requirements)
- Specimens collecting, processing and storage in monitored conditions
- Specimens shipment arrangement
- Study Monitoring
- Study audits
Type of studies
- First in Man
- Most of therapeutic areas
- All routes of drug administration
- Single and multiple doses projects
- Proof of concept studies
- Drug-Drug Interactions studies
- Drug-Food Interaction studies
- Alcohol interaction studies
- Tobacco interaction
- Age and Gender effect
- Special populations studiem
