Clinical Research Malaysia

7/27/2019 Clinical Research Malaysia

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CLINICAL RESEARCH MALAY

(CRM)CRM &

Industry Sponsored Research (ISR)

17th MALAYSIAN FAMILY MEDICINE SCIENTIFIC CONFERENCE 20

4th – 7th July 2013



CLINICAL RESEARCH MALAYSIA (CRM

ABOUT US

Clinical Research Malaysia (CRM) is a company fully owned byGovernment of Malaysia set up less than 10 months ago and a not for profit entity. The focus of the company is Industry SpResearch, with the vision to make Malaysia as the preferred dfor the industry



CLINICAL RESEARCH MALAYSIA (CRCRM’S FOCUS• Improving sites by addressing their needs and allocating trained st

coordinators.• Increasing investigators through mentoring programmes, training acampaigns.

• Implementing strategies and procedures for feasibility assessmentinvestigator selections.

• Providing transparent and efficient trial budget management.

• Initiating collaborations with local, regional and global stakeholde• Impacting global pharmaceutical companies and clinical research o

to invest in Malaysia.

• Inspiring private hospitals and universities to be part of this nation

• Investigating and addressing the perception and awareness of clin

among healthcare professionals, administrators, patients and the pu



Industry Sponsored Research (ISR)• Industry-Sponsored Clinical Trials are a subset of clinical research

include ALL THREE of the following factors in order to qualify for thtrial indirect cost rate:

1. The objective of the study is either:

• Testing of drugs, devices, diagnostics, treatments, interventionpreventive measures including testing for an unapproved indic

•

Data collection to increase knowledge that would lead to enhaand efficacy of a specified drug or device; AND

2. The study must involve contact with humans or retrospective revmedical records, clinical data or specimens obtained from contact w

3. The study must be industry sponsored or funded



Malaysia – Destination for ISR

• Investment to the country

•Employment

• Fully supported by Government

• Adequate research infrastructure to support the clinical stud

• Sufficient trained & experienced research staff

•

Experienced and Qualified Investigators• High subject Recruitment Rate and Retention Rate

• Qualified and Efficient IRB/IEC (on approval timeline)

• Good quality of clinical trial’s data

• Good network of clinical research centres (CRC)



Creating the ideal landscape

2007

A unit within theMinistry of Healththat facilitates

industry sponsored

research

2010

Became a project for

the HealthcareNational Key Economic

Area

2012Corporatised

body.Governmentowned, not-for-profit

Vision:

Malaysia as the preferred

destination for contract clinical

research



Info on number of ISR (by CRM)

11

12

23

13

18

14

12 12

18

16

0

5

10

15

20

25

30

January February March April May June July August September October N

No of new research approved monthly in 2012



Top 10 Therapeutic Area for ISR



Top 10 Sponsors for ISR





• Engage Regulators

• Engaging Industry (CRO, Pharma)

•

Engaging Service Heads in MOH, Pengarahs, ancilliaservices

• Building Research interest by participating in all staResearch Days

• Building forums and sponsoring speakers for these

meetings.

• Training (GCP, Study Coordinators)

• Engaging Medical Societies

• Participating in overseas conferences



Promoting Industry Sponsored Research:

• MOH Hospitals/KK - collaborative effort with CRC

• Private hospitals – collaborative effort through Associationprivate hospitals

• University Hospital – Collaborative effort with MOHE



Malaysian PROTEGES 2013

(PReparing Outstanding Clinical Research Talents by EnGaging Eminent Malaysi

I. Initiation Workshop for MentorsII. Initiation Workshop for Mentees

First programme was held on 13 and 27 April 2013

Second programme will be held on 11 and 25 July 2013

This programme will be conducted throughout Malaysia in the following region

1. Central Region: (Kuala Lumpur, Selangor, Putrajaya)2. Southern Region (Johor, Negeri Sembilan, Melaka)3. Northern Region (Penang, Kedah, Perlis, Perak)4. Eastern Region (Kelantan, Terengganu, Pahang)5. Sabah6. Sarawak



GCP Workshop• Fully organized by CRM

• Few venues has been proposed (according to region) – Nort

(Kedah), East Coast (Kelantan), Central (Putrajaya) & Sarawak

• Comparatively more affordable registration’s fee

Personalise visits• Identify new sites

• Meeting KOLs

• Engaging private hospital, Melaka, Kuala Lumpur & Penang iOncology, cardio & Psychiatry



Contract management

1. (i) Clinical Trial Agreement, review

(ii) Clinical Trial Amendment

2. Budget review



QUESTION & ANSWER SESSION

For further information, please contact:

Clinical Research Malaysia (1006282-X)

Address: Suite E-10-20, Amcorp Business Suites

Menara Melawangi, Amcorp Trade Centre,No. 18, Jalan Persiaran Barat, 46050 Petaling Jaya,

Tel: 603-79605153; Fax: 603-79321940

Documents

Clinical Research Malaysia