List of Services

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  • Wednesday, 10 January 2018 16:36

1. Bioanalytical Part:

Facilities:

a. LC-MC/MS systems. {(UP) LC-MS – Waters}
b. HPLC Systems:
  - Agilent
  - Shimadzu
   i. UV detector.
   ii. Flourscence detector.

c. Microbalance.
d. All study samples are stored in controlled freezers (-20°C and -70°C).
e. UPS (Uninterrupted Power Supply) and generator back-up.
  - Services
   i. Method Development.
   ii. Method Validation.
   iii. Bio-Waiver / Bioequivalence.

2. Data Management Part:

• Non-compartmental pharmacokinetic analysis using validated KineticaTM software.
• Assessments of Bioequivalence.
• Tabulation, graphical display, analysis and interpretation of study data.
• Study design and development of Protocol and Informed Consent Form (ICF).
• Designing of Case Report Form (CRF) as per protocol requirements.
• Preparation of Bioequivalence Report, Clinical Report, Analytical Report and Statistical Report.
• Sample Size Estimation and Randomization.

3. Clinical Part:

• Screening area for physical examination.
• Sample collection rooms.
• Complete examination of volunteers with close monitoring during two study phase for the expected AE/SE.
• Notify the drop-out volunteers with a copy from his analysis report, and follow them up.
• The BE Center contracted with El-Safwa Hospital for emergency cases.
• First Aid cupboard.
• Dining room.
• Storage freezers ( -70 and -20º C).
• Archives for secure document storage.

4. Quality Assurance System:

Quality Assurance Unit ensures that studies are performed in accordance with Good Laboratory Practice (GLP)-Good Clinical Practices (GCP) regulations and through in house procedures.
Also, it is responsible for document controlling of study protocols, analysis plans, SOPs & policies; and ensuring the updated versions of these controlled documents are effective and in place or accessible to relevant staff.

QA unit is responsible for regular auditng which include:
• Study source documentation, procedures, and reports; and provides regulatory advice and support to the operational staff.
• Facility & system, to check adequacy & eligibility of resources and proper utilization of provisions.

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