BIO1 is Biomapas’ early phase unit located in Lithuania’s leading university hospital-Vilnius University Hospital, Santaros Clinics (≈1400 beds).
Reasons for customers selecting BIO1 include the following:
- Excellent environment for patient recruitment due to investigators being financially and scientifically motivated, and where there is generally easy access to patients and healthy volunteers.
- Ethics committee time to approval is approximately 1-2 months.
- Strong partnerships and cooperation with key opinion leaders in a wide range of therapeutic areas who can bring their expertise to protocol development, clinical conduct and data analysis.
- The hospital’s ICU is in the same building.
- The BIO1 team has particular expertise in oncology, cardiology, dermatology and gastroenterology.
- The unit has 12 beds and is already appointed to expand to 20 beds if needed.
- The facility offers a large clinical space of 500 m2 plus an administrative area of 120 m2 – all of which is modern, immaculate and has the very latest equipment.
BIO1 offers a safe and comfortable environment for patients or healthy volunteers. It provides each customer with a project manager as a principle point of contact who oversees the whole process from recruitment to clinical study report.
The facility covers all types of early phase clinical studies, including first-in-human and proof-of-concept, single and multiple dose, bioequivalence, bioavailability, drug-drug and drug-food interaction, PK/PD, tQTc studies.
Additional services include:
- Protocol writing
- CTA submissions and Competent Authority/Ethic Committee approvals
- CRF Design
- Recruitment of Patients or Healthy Volunteers
- Quality Assurance
- Data Management
- Centralized laboratory
- ICU Access
- PK Analysis
- Statistical Analysis
- Clinical Study Report