Introduction:

Pharma/Biotech and CRO laboratories involved in drug development have to ensure quality as well as keep pace with changing regulatory requirements. In Bioanalytical laboratories, various steps critical to speedy project execution are method development and validation, method standardization and a configurable reassay decision process. On day-to-day basis an integrated system for sample management and tracking, accurate samples analysis, instrument interfacing, and configurable accurate reporting of results are key to efficient and economical project completion. ARK is a complete end-to-end solution for bioanalytical laboratory involved in clinical development.

• Sample management:
  Allows for easy and systematic tracking of sample shipments and storage.
• Security:
  Laboratory personnel access is controlled via roles and responsibilities ensuring data integrity.
• Interface with Statistical Software:
  
Interfaces smoothly with third party statistical software like SAS and WinNonlin.
• Audit:
  Audit trails track changes throughout bioanalysis making the process transparent. Makes the data auditable and reporting to regulatory authorities easier.

• Repository for Validated Method.
• Sample Tracking and Management .
• Elimination of paper based approvals with automated workflow.
• Inventory tracking with analyte/working standard accountability.
• Seamless Integration with Instruments – e.g. LCMS/MS, HPLC.
• Integration with third party software – Winonlin and SAS.
• Instrument Records: installation, qualification and periodic/routine calibration.
• Alerts - calibration expiry and inventory management.
• Complete report generation.