At Lambda we understand importance of time, that is why we offer comprehensive approach to BEQ project. We take care of all relevant aspects of clinical trials; from study design to Clinical Study Report preparation. Our wide experience in conducting such a studies, effective recruitment tools and good Clinical Unit organization allows us to perform project in required timeline. Well established quality system guarantee the highest quality of data.
We offer:
- Study Project Management
- Study design development / Pharmacokinetic Expert consultancy
- Expert Report preparation
- Identification of analytical part performer
- Protocol development / review
- Subject Information and Informed Consent Form preparation / translation / review
- CRF design / review
- Insurance policy arrangement
- CTA preparation for Project registration
- 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
- Quality Control - in process and retrospectively
- Quality Assurance audits
- Statistical evaluation
- Clinical Study Report preparation
