Early Proof-of-Concept (PoC) or Phase IIa studies in patients for an early go no-go decision.
Hospital-based sites
Established SOPs at investigator sites
Access to Intensive Care Unit of respective hospitals sites
Access-controlled Pharmacy
Sample transport from Investigator sites to Bioanalytical Unit
LCMS-based bioanalytics
On-line data entry and parallel evaluation
Access to Independent Ethics Committee/ Institutional Review Board
Key Opinion Leader in the concerned therapeutic area
Clinical Operations Team
Medical Writers
Data Managers
Biostatisticians
Regulatory Experts
Quality Assurance
Supporting Tea
Neurology
Psychiatry
Hypertension
Diabetes
COPD
Asthma
