NBU Departments‎

NBU is a Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) ‎compliant CRO. ‎

NBU has both an accredited facilities and a well-trained staff to conduct BE studies ‎from start to end in a cost-effective manner.‎

  • Ensures Compliance with laws / regulations and guidelines
  • Liaises with Institutional Review Board (IRB) Coordinator, Principal Investigator ‎‎(PI), Study Director (SD), Palestinian MoH and Insurance agent to ensure ‎compliance with NBU’s internal procedures, local and international guidelines and ‎regulations.‎
  • Liaises with all NBU’s departments and other Units within the University to ensure ‎compliance to internal procedures, local and international guidelines and regulations.‎
  • Reports to the Chief Executive Officer (CEO) / Managing Director on performance of ‎the Unit periodically.‎
  • NBU Custodian (for Archive, Chemical Store and Freezer Keeping)‎
  • Clinical Study Design
  • Study Protocol Preparation
  • Study Documents Preparation
  • Data Management
  • Pharmacokinetics (Pk) / Biostatistics‎
  • Final Reporting
  • Standard Operating Procedures (SOPs)‎

The NBU Bio-Analytical Laboratories are well-designed and equipped with GLP ‎compliance to provide Bio-analytical testing services, comprising the following:‎

  • High Performance Liquid Chromatography (HPLC) and Liquid Chromatography - ‎Tandem Mass Spectrometry (LC-MS/MS)‎
  • Deep freezers (studies samples and related reagents storage)‎
  • Chemical store (chemicals and analytical reagents storage).‎
  • Dedicated qualified / well-trained analysts
  • Facilitated accessibility to Peer Review Journals, United States Pharmacopoeia ‎‎(USP) and British Pharmacopoeia (BP)‎
  • Phase I studies conduct (Bioequivalence (BE)/ Bioavailability (BA)/ ‎Pharmacokinetics (Pk)), coordination and monitoring‎
  • Clinical facilities are designed with Automatic Real Time Monitoring & Control ‎System with alarm support
  • Generic and Testing drugs Inventory system control at NBU Pharmacy
  • Dedicated qualified / well-trained clinical team to: ‎
    • handle each clinical study responsibilities (Pre-within-after)‎
    • communicate with IRB for study protocol and final report approvals
    • provide a reliable Data Entry and study documentation
  • Server Room ‎
    • well–established as per relevant SOPs, Data Integrity Guidelines and 21 CFR Part ‎‎11‎.
    • With Automatic Real Time Monitoring & Control System with alarm support.‎
  • Software Implementation and validation.
  • Data Back-up processes control.
  • Database design, validation & monitoring.
  • Domain access control.‎
  • Calibration and Qualifications completion in a safe, timely, and accurate manner, ‎following specific policies and proposals.‎
  • Proper handling and maintenance of NBU’s instruments/ equipments, including ‎testing and standard equipments.‎
  • Working on departments' needs and requirements recognition through effective ‎communication. Thus, conveyance of different NBU departments’ requests to the ‎management will be ensured and that the resources are met in accordance with ‎management direction.‎
  • GxP documentation, following NBU’s specific policies and procedures, and in a safe ‎manner.‎
  • Instrument Master File Record (IMFR) initiation and updating
  • Following on Change Control (CC) procedures ‎
  • Serves as point of contact with external Calibration / Maintenance vendors.‎
  • GCP-GLP guidelines conduct assurance ‎
  • NBU Quality Manual
  • NBU Labs Safety Manual
  • SOPs
  • Training
  • Documents Control
  • Calibration / Validation
  • Internal Audits

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