Zi Diligence at a Glance

Clinical unit

• The teams are unified with a common goal – to be a global leader in early-stage research, offering innovative, flexible and client-focused solutions to bring novel and affordable medicines to the market.
• Zi Diligence has a fully-equipped clinical investigation unit, well-suited for bioequivalence and bioavailability studies.
• Up to 48 beds to accommodate 48 healthy human volunteers at a time on the air-conditioned clinical unit in a separate floor in the Zi Diligence Center. Well-equipped Emergency unit.
• Dedicated pharmacy with temperature control and humidity monitoring
• Zi-clinic consists of well-equipped physician room, Dose administration rooms and phlebotomy stations (for screening).
• Synchronized clocks to facilitate standardized times entries.
• -70°C & -20°C freezers for proper retention of blood samples.
• Computerized temperature monitoring system for freezers programmed to alert (mobile call) assigned staff members of excursions.

Archiving facilities:

• Secured limited access archive with fire proof door and automatic fire fighting system.
• Server for electronic backup.

Our Lab

• Fully-equipped high standard bioanalytical facilities to ensure the successful application and reproducibility of an assay results and to support clinical studies
• Zi Diligence Bioanalytical laboratory have fully GLP-compliant bioanalytical facility with state-of-the-art LCMSMS instruments managed by highly skilled and experienced scientific professionals and support personnel.
• Our experienced staff offers a full range of LC/MS/MS bioanalytical services, from method development, method validation, and sample analysis in accordance with current international regulatory requirements with assurance of precision, accuracy and stability checks.
• Our systems use validated software which is CFR 21 Part 11 compliant. All data is electronically transferred and documented and all studies are inspected by the QA in process control and subjected to periodic internal audits to ensure compliance.

Facility and Instrumentation:

Zi Diligence laboratories are equipped with State-of-the-art facilities for bioanalysis, an instrumental labs and a sample processing areas with latest bioanalytical technologies. The Bio-Analytical data is electronically transferred and stored on servers. The server is backed up onsite and offsite.

• LC-MS/MS systems.

AB Sciex (API 6500, API 5500 plus, API 5500 Q-Trap, API 4500 and API 4000).

Waters (Xevo TQD).

• HPLC systems:

1 Waters UPLC systems with UV Detectors and automated 96-well auto samplers.

1 waters HPLC alliance UV Detector and automated 96-well auto sampler.

1 Agilent HPLC 1260 UV Detector and automated 96-well auto sampler

Quality Policy Statement

Quality is integrated into all of our clinical and analytical practices at Zi Diligence research center. We are nationally and internationally accredited in the field of pharmaceutical and clinical research in MENA region

Our experience and oversight ensure that our clinical, bio-analytical and related services comply with Gulf Corporation Council (GCC) Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Food and Drug Administration (FDA), International Conference on Harmonization (ICH) GCP guidelines. At Zi Diligence, we build quality into all our services.

A key way to achieve this is by operating a Quality Management System (QMS) in accordance with the requirements of ISO 17025:2017 and ISO 9001: 2015.