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