Clinical Solutions
Info Kinetics currently provides services which guarantee confidentiality, integrity, technical excellence and commitment to schedules. Our clinical solutions include:
- Phase I / Early phase studies
- Phase II-III studies
- Clinical trial protocol Design and Review
- Research subject Recruitment and Management
- Submission to Ethics Committee for ethical approval
- Data Management
- Pharmacostatistical Analysis / Consultancy
- Study Report Writing
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Phase I specialties:
| > | Early Phase Research in Man | > | Food effect study |
| > | Bioavailability / Bio-Equivalence Studies | > | Race effect study |
| > | ADME | > | Gender effect study |
| > | Drug-drug interaction study |
Subject recruitment for Phase 1 studies is carried out at the clinical research site located at Hospital Pantai Penang, a hospital accredited by Malaysian Society for Quality Health (MSQH) and undergoing JCI accreditation. Info Kinetics has a team of research professionals who are trained and experienced in all aspects of clinical development and in virtually every therapeutic area.
While Info Kinetics is committed to provide quality services to its clients, the safety and rights of subjects are protected. Our unique set up enables the conduct of multiple studies concurrently. Studies are conducted with the availability of a 24-hour emergency support system in Hospital Pantai Penang.
Facilities at the clinical suite include:
- a dedicated 36-bedded ward (expandable if required) that is well-equipped for clinical trial activities.
- a semi-private meeting room.
- a cable-television room and subject recreation area.
- two separate consultation suites.
- a sample-handling laboratory with a refrigerated centrifuge.
- a temperature-controlled drug storage area with limited access.
- refrigerators and freezers (-25°C & -70°C) for drug and sample storage
- Synchronised digital clock.
- RFID system to monitor subject movement and activities [LibertyTM System]
- Wi-fi enabled for convenience of Study Subjects and Study Monitors
Phase II-III therapeutic areas covered:
| > | Cardiology | > | Obstetrics and gynaecology |
| > | Endocrinology | > | Oncology |
| > | Fertility | > | Ophthalmology |
| > | Gastroenterology | > | Orthopaedics |
| > | Gerontology | > | Paediatrics |
| > | Haematology | > | Respiratory medicine |
| > | Internal medicine | > | Surgery |
| > | Nephrology | > | Urology |
| > | Neurology |
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