NBU Services / Activities
Phase I :Bioequivalence/ Bioavailability/ Pharmacokinetics Studies
NBU has its own accredited clinical unit, comprising the following:
- 1 clinic (More than 40 Beds)
- 1 Emergency Room (ER)
- Pool of Subjects
- Prepared as per NBU SOPs and Palestinian MoH Guidelines
- Dedicated qualified / well-trained team
- Accredited Diagnostic Labs.
- Dedicated temperature / humidity controlled Pharmacy (NBU Facility)
Services
- Study Design
- Communication with IRB
- Study Protocol Development
- Informed Consent Form (ICF) and Case Report Forms (CRFs) Preparation and submission
- Study Documents development
- Clinical studies conduct, coordination and monitoring
- Data Entry
- Study Samples regulation
- Central Investigational Product (IP) storage and distribution services
- Central Laboratory Services
- Data Management and Medical Writing
- Pharmacokinetics (Pk) / Biostatistics
- Final Report development
- Archiving of all study related data and biological materials.
- Method Development & Validation
- Support for Pre-Clinical Animal Studies
- Support for Clinical Trials
- Pharmacokinetic (PK) Analysis
- Bioavailability (BA) Studies
- Bioequivalence (BE) Studies
- Drug Interaction Studies