Early Phase Unit (Lithuania)

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
  • Monitoring
  • Quality Assurance
  • Data Management
  • Centralized laboratory
  • ICU Access
  • PK Analysis
  • Statistical Analysis
  • Clinical Study Report