Clinical Research Supporting Unit

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Background

In the era of globalization, many industries pharmaceuticals, herbal-medicines/jamu, food supplements, cosmetic and personal care products are compelled to provide products with quality assurance by clinically proven safety and efficacy. This quality can be can be achieved by performing clinical studies with better planning and management in compliance with Good Clinical Trial Practice (GCP). These activities include designing study protocols, performing clinical trials, statistical analyses and writing study report appropriately to achieve the ultimate goals.

The Clinical Research Supporting Unit (CRSU), Faculty of Medicine, Universitas Indonesia is available with its professional experience to help you cope with your clinical research problems.

To comply with our philosophy : “to provide the best”, CRSU is staffed by a team of professors, PhDs, MDs, Pharmacists and Pharmacologists experienced in clinical pharmacology and conducting clinical trials

Vision

To be one of the leading Clinical Research Organization in Indonesia and overseas in organizing and conducting clinical studies in accordance with ICH-GCP

Mission

To improve the quality of clinical trials in Indonesia

To Fulfill the stakeholders’ needs in terms of clinical trials in compliance with ICH-GCP

Services

Protocol Development

Obtaining Ethical Clearance

Clinical trial coordination with ICH-GCP standards

Coordinating multi-center studies

Monitoring

Data Management and Statistical Analyses

Complete Medical Writing Services

Types of Clinical Studies :
       – Clinical Studies phase, II, III & IV on:
              drugs, herbal medicine/jamu, nutritional products & food supplements

       – Cosmetics & personal care products :
              SPF, patch test

Courses :
       – Good Clinical Practices
       – Clinical Trials & Methodology
       – Drug Evaluation & Registration

Procedure

mechanism for using services of
Clinical Research Supporting Unit (CRSU)
Medical Faculty Universitas Indonesia (FMUI)
as Contract Research Organizer

Sponsor sends letter of intent using services of CRSU as CRO to Dean Medical Faculty Universitas Indonesia

Approval From the Dean

Assigment letter to CRSU
made by the Dean and invoice issued by FMU

Payment of services by
the sponsor to FMUI

CRSU carries out the role as CRO according to agreement