جامعة النجاح الوطنية
An-Najah National University

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 with internal procedures, local and international guidelines and regulations
  • Reports to the Chief Executive Officer (CEO) on the performance of ‎the Unit periodically
  • NBU Custodian (for Archive, Chemical Store, and Freezer Keeping) ‎

The Department’s main responsibilities include:

  • Clinical Study Design
  • Study Protocol Preparation
  • Study Documents Preparation
  • Data Management
  • Pharmacokinetics / Biostatistics‎ analysis
  • Preparation of the final report
  • Preparation of the related Standard Operating Procedures (SOPs)‎

Well-designed and equipped with GLP ‎compliance to provide Bio-analytical testing services, comprising the following: ‎

  • Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) ‎
  • Deep freezer facility ‎
  • Chemical store
  • Facilitated accessibility to Peer Review Journals, United States Pharmacopoeia ‎‎(USP) and British Pharmacopoeia (BP)‎

It operates a site for performing Phase-I clinical trials including Bioequivalence/Bioavailability/‎Pharmacokinetic studies. It has the capacity to arrange and operate a clinical site at the University Hospital (JCI accredited) to perform Phase-II and III clinical studies in different therapeutic areas under the supervision of competent clinical and technical staff. The responsibilities of the department mainly include:

  • Leading, managing and integrating all the clinical operations team activities, leveraging internal and external resources, expertise and knowledge, along with optimizing NBU’s resources, expertise and knowledge.
  • Providing strategic input and execution of the study from protocol design to the final clinical study report for the studies.
  • Managing all aspects of NBU vendor identification, request for proposal submission, site selection, and the day-to-day operational management activities of NBU clinical operations team.
  • Participating in Case Report Form design, Informed Consent Form development and Trial Master File initiation and maintenance.
  • Providing support to the clinical operations team throughout the conduct of the study.
  • Supervision and training of the clinical staff on the related SOPs, guidelines, and regulations.
  • Coordinating with the clinical site in preparation for and managing the study procedures within the site.
  • Writing and reviewing the related SOPs
  • Ensures all the processes compliance by following the established guidelines of national and international regulatory authorities in addition to internal SOPs 

It is mainly responsible for:

  • Ensuring that all processes contributing to the performance of a clinical studies are conducted properly
  • Managing and maintaining databases for the quality system (if applicable)
  • Preparing annual reports and quality trending reports
  • Reporting the status of the quality levels of staff, systems and services activities
  • Evaluating quality events, incidents, queries, and complaints
  • Keeping up to date with all related quality legislation and compliance issues
  • Documenting internal regulatory processes
  • Ensuring regulatory rules are communicated through NBU policies and procedures
  • Utilizing guidance documents, international standards, or consensus standards and interpret for guidance
  • Ensuring that investigator, study director; vendor, facility and system audits are conducted
  • Communicating any critical compliance risks noted from study-relevant activities/tasks to senior management
  • Assuming a lead role in the preparation, conduct, and responses to the regulatory agency
  • Reviewing and approving SOPs whenever applicable
  • Ensuring all the processes compliance by following the established guidelines of national and international regulatory authorities in addition to internal SOPs

It is mainly responsible for:

  • Calibration and Qualifications completion safely, timely, and accurately by ‎following specific policies and proposals
  • Proper handling and maintenance of NBU’s instruments/equipment, including ‎testing and standard equipment
  • 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 ‎
  • Serving as a point of contact with external Calibration / Maintenance vendors

It is mainly responsible for:

  • Software installation, implementation and validation
  • Data backup processes control
  • Database design, validation & monitoring
  • Domain access control
  • Operating server room as per relevant SOPs, Data Integrity Guidelines and 21 CFR Part ‎‎11‎‎

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