IMU-MOH Clinical Trial Unit

Overview

IMU University’s Clinical Trial Unit was established to meet the growing demand for a dedicated facility that conducts high-quality, innovative clinical studies addressing critical gaps in medical research and patient care.

Based at Klinik Kesihatan Seremban, the unit is a collaboration between IMU University and the Ministry of Health. This partnership leverages shared expertise and resources to support groundbreaking research while fostering advancements in patient care.

The Clinical Trial Unit aims to become the leading hub for primary care-based clinical research, addressing diverse healthcare challenges through evidence-based solutions.

At IMU, we excel in Investigator-Initiated Research, offering expertise and infrastructure to advance independent research goals. Additionally, we provide comprehensive support for Investigator-Sponsored Research and Industry-Sponsored Research, ensuring a complete spectrum of services to meet diverse clinical trial needs.

Vision

To be a leading centre of excellence in clinical research, advancing healthcare through innovative, patient-focused trials that accelerate the development of life-changing therapies and improve global health outcomes, and establish itself as the hub for primary care-based clinical research.

Mission

Our mission is to conduct high-quality, ethical clinical trials that drive medical breakthroughs and enhance patient care. By leveraging state-of-the-art facilities, expert teams, and collaborative partnerships, we aim to deliver reliable, timely, and impactful results that contribute to the advancement of medical science and the well-being of patients worldwide.

Services

Clinical Trial Design and Protocol Development

Assistance with designing and refining study protocols
Expert advice on trial methodology and statistical analysis

Regulatory and Ethical Approvals

Support with Institutional Review Board (IRB) submissions
Assistance with ethics committee approvals and regulatory submissions package

Study Feasibility and Patient Recruitment

Feasibility assessments to determine patient availability and site capabilities
Targeted patient recruitment and retention strategies

Project Management and Study Oversight

Dedicated project management for seamless trial execution
Budget and timeline management
Risk management and issue resolution
Comprehensive trial coordination from start to finish
Coordination between clinical teams, CROs, and sponsors

Final Reporting and Publication

Preparation of study reports for regulatory submissions and publication
Assistance with manuscript preparation and submission to journals

Legal Review and Budget Negotiation

In -house legal team to review Clinical Trial Agreement
In- house budget review by Business Engagement Office
Work closely with Clinical Research Malaysia to ensure compliance with Government policies and other regulatory standards.