Info Kinetics Sdn. Bhd.

Facilities at Clinical Sites
• A dedicated 40-bedded ward (expandable if required) at Gleneagles Penang and a 24-bedded ward at LohGuanLye Specialist Centre that is well-equipped for clinical trial activities
• Subject recreation room with sofas, TV and Xbox.
  Two separate consultation suites
• A temperature-controlled drug storage area with limited access
• A semi-private meeting room
• Access controled with internal monitoring cameras, automatic alarm systems and fire & smoke detectors
• Synchronized digital clocks

Facilities at Bioanalytical Site

• LCMS/MS, GCMS and HPLC
• Sample-handling laboratory
• Refrigerated centrifuge
• Refrigerators and freezers (–25 °C & –70 °C) for drug and sample storage

Studies are conducted with the availability of a 24-hour MO & emergency support system in Gleneagles Penang and LohGuanLye Specialist Centre. Blood samples from both sites are analysed in Gleneagles Penang which operates under strict OECD-GLP compliance.
Over 250 BE studies covering most major therapeutic classes have been conducted at these clinical sites since the establishment of Info Kinetics Sdn. Bhd., with the bulk of it being pivotal studies conducted with the intention to gain market authorization in Asia, Europe, Australia, North America and African countries.
Patient recruitment is managed by Info Kinetics, with the availability of a volunteer database of about 1000 potential study participants.”

Info Kinetics maintains strict ICH-GCP compliance in all its trials at both clinical sites and has been inspected by the French Regulatory Authorities in 2008, Malaysia’s National Pharmaceutical Control Bureau since 2006 and the U.S. Food and Drug Administration in 2013. Info Kinetics’ bioanalytical laboratory is ISO/IEC 17025 accredited and OECD-GLP accredited.