CRM Corporate Profile 2016
26
Developing Clinical Research as an Economic Growth Engine Convergence of the Government, Science And Industry www.clinicalresearch.my CORPORATE PROFILE 2016
Transcript of CRM Corporate Profile 2016
Developing Clinical Research as an Economic Growth Engine
Convergence of the Government,Science And Industry
www.clinicalresearch.my
CORPORATE PROFILE
2 0 1 6
OTHER PUBLICATIONS BY CRM
The CRM Bulletin is published three times a year with a print run of 3000 copies per issue. These are delivered complimentary to a local and foreign readership base comprising of: Doctors and investigators (public and private); Hospitals (public and private); Sponsors and CROs; Universities and academics involved in clinical research; Medical research centres; Senior government and MOH of�cials; Clinical Research Centre (CRC) staff and investigators; Ethics Committees, Patient support groups; and selected medical schools.
The print run is complemented by an online subscriber who receive an online copy of the CRM Bulletin.
The bulletin’s objectives are to spread awareness about Malaysia’s capabilities in industry sponsored clinical research (ISR), inform and attract industry players to Malaysia, motivate and educate potential investigators and support staff, build public awareness about the importance of clinical research, and �nally serve as a forum to share news and development relevant to all stakeholders.
NCCR bulletin Guide for Industry Patient BrochureGuide to BA/BE Centresin Malaysia
Malaysian Guide on the use ofHuman Biological Samples
for Research
bulletin
Research Personality: Dr. Zanariah HusseinConsultant Endocrinologist and PhysicianHospital Putrajaya
When passion drives research:Greentown Health Clinic Pragmatic approach to cluster
randomized trials
Working with CRM to move Malaysia forward
Putrajaya Hospital –Malaysia’s Endocrine Centre
By Clinical Research Malaysia
of Clinical Research and Therapy
ISSUE
07
DRIVERS OF
CHANGE INENDOCRINOLOGY
DRIVERS OF
CHANGE INENDOCRINOLOGY
Clinical Research Malaysia (CRM) is a non-pro�t company wholly owned by the Government of Malaysia’s Ministry of Health. CRM was established in June 2012 to position Malaysia as a preferred global destination for industry-sponsored research (ISR) and to function as an enabler and facilitator to the industry and medical fraternity for the conduct of clinical trials.
By working with other stakeholders, CRM strives to improve the local ecosystem to support growth in ISR, facilitate the needs and requirements of industry players, grow the pool of capable investigators, support staff and trial sites, and improve their capabilities and capacities to conduct ISR.
With the Ministry of Health’s backing and clear knowledge of the local research environment, CRM is able to provide sponsors (primarily from the pharmaceutical, biotech and medical device industries) and contract research organizations (CRO) with an extensive range of services that includes feasibility studies, investigator selection, placement and development of study coordinators, management of trial budget, review of clinical trial agreements and updates on local laws, guidelines and regulations. CRM also undertakes marketing and promotional activities to build industry awareness about the opportunities for ISR in Malaysia, and create public and patient awareness of clinical trials.
in Brief
Your Global ISR SolutionsIn One Nation
Malaysia offers a compelling package to sponsors and CROs when it comes to conducting ISR clinical trials. Simply put, a very strong emphasis on patient safety and bene�t is combined with a well-developed and equipped healthcare system that is manned by well-trained, highly-quali�ed and English literate medical professionals. As icing on the cake, Malaysia’s multi-ethnic population provides sponsors and CROs with access to genetic diversity while the costs of conducting clinical trials are very competitive when compared to neighbouring countries.
Since its establishment in June 2012, Clinical Research Malaysia (CRM) has focused strongly on growing the pool of quali�ed investigators and clinical sites throughout Malaysia, as well as providing important support services and helping to equip sites and investigators with the necessary resources to function optimally.
Equally important to CRM is to assist sponsors and CROs by facilitating their activities in relation to initiating and managing clinical trials, and working with regulators and Institutional Review Boards (IRBs) to improve turnaround times, delivery standards and the clinical research ecosystem.
These initiatives have helped tremendously in attracting new industry sponsored clinical research (ISR) to Malaysia, although undeniably a lot more still has to be done to sustain the growth rates. Indeed, it is imperative for CRM to continuously improve its effectiveness and scope of services and to work with other stakeholders to further optimise the ecosystem to support the conduct of ISR.
The strategic objective is to put in place a comprehensive, enabling and supportive ecosystem that meets the needs of industry players and investigators, and thereby accelerate the development of a thriving clinical research industry in Malaysia.
The building blocks towards this end are already well in place and we welcome industry players and potential investigators to discuss with us on how they can tap into what Malaysia has to offer.
• To keep growing the pool of investigators and sites.
• To keep attracting new ISR to Malaysia.
• To enhance cooperation with industry players and all stakeholders including the Clinical Research Centre Network.
• To keep growing awareness and support among industry players, medical fraternity, the public and patients.
• To intensively develop human capital in CRM.
MOVING FORWARD, OUR STRATEGY IS TO FOCUS ON 5 KEY ACTIONSWHICH CAN BE SUMMARIZED AS:
Dr. Akhmal YusofChief Executive Of�cer, CRM
Message From The CEO
ABOUT
Our Vision To establish Malaysia as apreferred destination for industry sponsored research (ISR)
These values convey the philosophy behind every decision and move we make.Transparency, honesty, accountability and trustworthiness – are our core value.
Our CoreValues
We practice transparency and openness in all our operations, including �nancial processes and budget management.
Transparency
We aspire to be honest with one another, our clients and our business partners.
Honesty
We adhere to the highest standards of professionalism and integrity anduphold the faith and con�dence our clients have placed in us.
Trustworthiness
We set a high performance expectations and hold ourselves responsiblefor the quality of our work and the results we achieve as individual, as a team and as a company.
Accountability
Our 5 Key Strategies
Remove obstacles without compromising the rules and regulations (e.g. Expand Feasibility team, NEW CTA, Med Device ISR)
GROWINDUSTRYSPONSOREDRESEARCH(ISR)
Develop new investigators & prepare sites for new ISR (resources, facilities e.g. Young Investigators’ Awards)
GROWPRINCIPALINVESTIGATOR& SITES
Work with all (CRC, CROs, MNCs, SCRPM, MDA, Biotech Corp, Royal Customs, ECs/IRBs, MOE, MIDA, InnoBio) aiming to harmonize the ecosystem in Malaysia
COLLABORATEWITHSTAKEHOLDERS
Continue activities that brings the ROI eg CRM Bulletin Develop NEW activities: Local (NHAM, NNS, FMSA etc) & International Promotion (Biopharma Asia, DIA Europe & USA)
CREATEAWARENESSOF CRM
Select the right people for the right job, PMS (objectives, coaching & appraisal) Develop people through NEW initiatives: SC training: Beginners, Intermediate, Expert, English Business Comm Skills, Managerial training: 7 Habits, Situational Leadership
DEVELOPHUMANCAPITAL
ISR
Scope of Services
CRM CURRENTLY PROVIDES THE FOLLOWING SERVICES:
Consultation and management of clinical trial budget• CRM advices investigators and sponsors/CROs on the clinical trial budget. This service ensures that resources are suf�cient in order to complete all obligations of the clinical trial.
• CRM manages the trial budget with full transparency and schedule reports to investigators and the sponsor/CRO ( CRM charges a fee of 15% above the value of the trial budget which will be utilized to �nance its operations and training programmes to upskill investigators and support staff).
Review of Clinical Trial Agreement (CTA) & Non-Disclosure Agreement (NDA)• CRM assists investigators & sponsors/CROs by reviewing and advising on Clinical Trial Agreements (CTAs) & Non-Disclosure Agreements (NDAs).
• CRM’s experienced legal team will provide assistance to review the CTA/NDA.
Development & placement of study coordinators• CRM recruits suitably quali�ed candidates and trains them to become capable Study Coordinators (SCs) who will then be placed at trial sites in order to assist investigators.
• CRM currently has a pool of 75 trained SCs based in major clinical research centre nationwide.
Feasibility studies & investigator matching• CRM evaluates feasibility studies/request that are forwarded by sponsors/CROs and disseminates them to a large pool of potential investigators.
• CRM assist investigators who are interested to take-on the trial to complete and submit the feasibility study/request to the sponsor or CRO.
Training related to Clinical Research• CRM organizes various subsidized training programs for investigators and support staff in order to improve their capabilities to undertake ISR.
• Refresher Courses on Good Clinical Practise (GCP) are also held for doctors and support staff.
Sites capability improvement & enhancement• CRM improves the capability of sites by assisting in both systems and infrastructure improvements.
Growing the pool of investigators and sites • CRM continuously attracts and develops potential new investigators and sites in both the public & private healthcare system.
One-stop centre for the industry • CRM assists industry players in resolving issues or delays faced with government agencies and regulators (eg. BLESS, MREC, MDA, NPCB, IRBs) that may delay the approval or initiation of trials.
Improving public and patient awareness • CRM engages with a variety of patient support groups and NGOs, undertakes advertising and promotional events, and seeks to generate positive media coverage to spread the word about clinical research, generate goodwill and to facilitate patient recruitment.
Promoting Malaysia asa hub for Industry Sponsored Research (ISR)• CRM participates in domestic and international events to engage sponsors and CROs as well as to promote Malaysia as a choice destination for ISR.
ISR
Board of Directors
YB Datuk Seri Dr. S. Subramaniam is Malaysia’s Minister of Health. He concurrently holds the position of the Deputy President of the Malaysian Indian Congress (MIC) and is the Member of Parliament representing Segamat since 2004. Dr. Subra, as he is known to many, is a dermatologist by training.
YB Datuk Seri Dr. S. Subramaniam a/l K. V. SathasivamMinister of Health
Y. Bhg. Datuk Dr. Chen Chaw Min is the Secretary General in the Ministry of Health, Malaysia. Prior to this, he was the Deputy Secretary General (Finance) at the Ministry of Health. He has an MBA from the University of Illinois Urbana Champaign and a PhD from University Putra Malaysia.
Y. Bhg. Datuk Dr. Chen Chaw MinSecretary General, Ministry of Health
Y. Bhg. Datuk Dr. Noor Hisham is currently the Director General of Health, Malaysia. Prior to this, he was the Deputy Director-General between 2008 and 2013. A well-trained surgeon and administrator, he was previously the Head and Senior Consultant Breast and Endocrine Surgeon at Putrajaya Hospital.
Y. Bhg. Datuk Dr. Noor Hisham bin AbdullahDirector-General of Health
Y. Brs. Dr. Shahnaz is the Deputy Director General of Health (Research & Technical Support) in the Ministry of Health, Malaysia. She is responsible for the supervision of the 6 research institutes under the Ministry of Health. Prior to this, she was the Director of the Institute for Medical Research.
Y. Brs. Dr. Shahnaz binti MuradDeputy Director-General of Health (Research & Technical Support)
Board of Directors
YB Senator Datuk Prof Dr. Sim Kui Hian is an internationally recognized expert in the �eld of cardiology. He is Visiting Senior Consultant Cardiologist and Visiting Senior Research Fellow at the Sarawak General Hospital (SGH) Heart Centre and Clinical Research Centre, SGH, respectively, since 2011.
YB Senator Datuk Prof Dr. Sim Kui HianSenior Consultant Cardiologist
Y. Brs. Dr. Goh Pik Pin is currently the Director of the National Clinical Research Centre, overlooking the management and operations of 31 Clinical Research Centres throughout Malaysia. An avid advocate of research, she was previously a Consultant Ophthalmologist at Selayang Hospital.
Y. Brs. Dr. Goh Pik PinDirector, National Clinical Research Centre (CRC)
Mr Ewe is currently Executive Director of the Pharmaceutical Association of Malaysia (PhAMA) and has held this position since 2013. He graduated with a Bachelor of Pharmacy (Honours) from Universiti Sains Malaysia and have an extensive experience in the pharmaceutical industry with stints in Merck Sharp Dohme (MSD) as a Country Manager and Managing Director from 1994 to 2012 before assuming his current position at PhAMA.
Mr Ewe Kheng HuatExecutive Director of the Pharmaceutical Association of Malaysia(PhAMA)
Prof Adeeba is the Dean of the Medical Faculty at Universiti Malaya and has been a lecturer in this faculty since 1997. She received her MBBS from Monash University Australia before obtaining an FRACP and most recently earning a Doctor of Law (honoris causa) from Monash University Australia. She was the President of the Malaysian AIDS Council from 2006 to 2010 and is currently the Chairman of the Malaysian AIDS Foundation, a position she held since 2006.
Prof Dr Adeeba Binti KamarulzamanDean of the Medical Faculty at Universiti Malaya
Senior Leadership Team
Dr. Akhmal Yusof obtained his Bachelor of Medicine and Bachelor of Surgery (MBBS) from the Royal College of Surgeon, Ireland in 1992. He started serving the Ministry of Health as a House Of�cer at the University of Malaya Medical Centre and subsequently as a Medical Of�cer at Tanjong Karang Hospital, Kuala Lumpur Hospital and Tawakal Medical Centre between 1993 and 2000.
He later ventured into Medical Insurance under the American International Assurance, Kuala Lumpur as Medical Manager (2000–2002). It was in AstraZeneca Sdn Bhd where he gained extensive experience in the �eld of research-based biopharmaceutical where he was the Medical Director across Malaysia, Singapore and Brunei. He later assumed the position of Head of Goverment Affairs. Dr. Akhmal was in AstraZeneca Sdn Bhd from 2002 to 2015.
Dr. Akhmal is currently a member of the Ethics Committee of the Pharmaceutical Association of Malaysia (PhAMA) and a member of the National Committee for Clinical Research (NCCR). He is currently the Chief Executive Of�cer of Clinical Research Malaysia.
Education: MBCh, BAO (National University of Ireland), LRCP & LRCS (Ireland)
Dr. Akhmal YusofChief Executive Officer
Senior Leadership Team
Matron Wakia has 40 years’ nursing experience at various government hospitals and retired as a Matron from Hospital Selayang. After retirement, she joined Clinical Research Centre from 2007 to 2012. She joined CRM as Clinical Operation Manager in 2012 and was promoted in 2013 as the Head of Clinical Operations.
Wakia WahabHead of Clinical Operations
Dr Khairul Faizi graduated with honors from Moscow Medical Academy. He completed his compulsory service to the government in Hospital Sultanah Bahiyah at the Emergency Department before venturing into the private sector.
He joined the pharmaceutical industry in 2012 and worked with AstraZeneca (AZ) and Boehringer Ingelheim (BI) where he was involved in Cardiovascular and Diabetes therapeutic areas, handling Medical Affairs as well as Clinical trials. He was involved in monitoring and early feasibility of trials which includes EPICOR Asia, CEPHEUS-5S, RECOVERY, Investigator initiated trials for Brilinta and Empagli�ozin.
Dr Khairul received the Country Presidents Award twice and the Asia Area Vice Presidents Award while in AZ and Best Diabetes team in SEA and South Korea during his tenure with BI.
Apart from his active role in the pharmaceutical industry, he has been involved as an advisor and later on appointed as a board member for Mahsuri Medical Centre Jitra, Kedah where he contributed to the upgrading of the center from a polyclinic to a private hospital. The revenue of the center saw an exceptional growth under his stewardship.
Dr Khairul Faizi KhalidHead of Business Development
Senior Leadership Team
Yau Yit Huan completed his professional accountancy quali�cation from the Association of International Accountants (AIA), United Kingdom. He has 18 years of experience in accounting, �nance and auditing. Mr Yau joined CRM as Finance Manager in the year 2013 before being promoted to the position of Senior Finance Manager and subsequently as Head of Finance & IT.
Yau Yit HuanHead of Finance & IT
Siti Nur Binti Makni completed her Bachelor of Business Administration (Honours) majoring in Management from Multimedia University in 2007. She then went on to obtain a Masters in Management from Open University Malaysia in 2010. She has been working in Human Resource Management for a total of 10 years in various industries including telecommunications, automotive, oil and gas and healthcare. Siti Nur has an extensive experience in a wide spectrum of human resource functions such as in recruitment, training and development, performance management and rewards, compensations and bene�ts as well as in industrial relations and administration.
Siti Nur MakniHuman Resource Lead
Senior Leadership Team
Marsita completed her LLB in 2012 from Universiti Sultan Zainal Abidin and went on to obtain an LLM from the University of Malaya. Before joining CRM in April 2015, she served as a Legal Of�cer at University Malaya Medical Centre. Marsita is now a Senior Legal Executive and reports directly to the CEO.
Marsita Husna Mohammad SallehSenior Legal Executive
Organization Chart
SITI NUR MAKNILead of Human Resource
INTAN MUNIRAH MOHD MURADClinical Operations Executive
HONG CHI KIENFinance Manager
DR. KHAIRUL FAIZIHead of Business Development
DR. AKHMAL YUSOFChief Executive O�cer
NORMAHIZON BT MOHAMEDExecutive Assistant
LEGAL & REGULATORY AFFAIRS
FARIDZ BIN MUSA Legal Executive
MARSITA HUSNA MOHAMMAD SALLEH Senior Legal Executive
BUSINESS DEVELOPMENTFINANCE & IT
SARENA HASNIZASenior Finance Executive
NUR SYAZWANI AHMAD SAFIANFinance Executive
KOMALA A/P PANNIR SELVAMPurchasing & Admin Executive
MOHD ROZAIDI SALLEHIT Executive
YAU YIT HUANHead of Finance & IT
MOHD FARID ABU BAKARHuman Resource Executive
HUMAN RESOURCECLINICAL OPERATIONS
WAKIA WAHABHead of Clinical Operations
SITE DEVELOPMENT
WONG SOK YEEClinical Operations Assistant Manager
NOOR IZZATI MASRIClinical Operations Executive (MDA)
DR. NOORZAIHAN MAT RADIFeasibility Specialist
DR. TAY WAI CHENG Senior Feasibility Specialist
DR. GURINDER KAURFeasibility Specialist
FEASIBILITY
ASHA A/P THANABALANAssistant Manager (MREC)
NORAFIZAA YUSOPResearch Assistant (MREC)
MREC
SITE MANAGEMENT
AUDREY OOIBusiness Development Senior Executive
NORZALEKHA YAZIDBusiness Development Senior Executive
SYED HAMZAH SYED NOORDINBusiness Development Executive
KRISHNA VENI THANGAMANYBusiness Development Executive
BUSINESS
TAN SIA HONGSenior Study Coordinator
ROSLIN GUADIHSenior Study Coordinator
TAN HOON YIANAssistant Regional Manager - Sabah& Sarawak
HARNANI TAMMATAssistant Regional Manager - Southern
PAVITHRA JANARSANAssistant Regional Manager - East Coast
Hospital Miri
SALINA LISANG
Hospital PutrajayaNORJURINA ABDUL TALIB
Hospital Kota SamarahanJERRY ANAK GERUNSIN
LAU SIAU TINGSULIANA AK CHARLES NYUCONG
Institut Kanser Negara (IKN)TBA
Hospital Serdang
FAIZAH CHE HASSANBALVINDER KAUR
SITI ROHAYA DAUDVITHIYA A/P VIYAPURI
Hospital Tuanku Ja’afar Seremban
MAISARAH NOOR SITI HAWA MD. YUSUFF
Hospital MelakaANTHONY AROKIAM FRANCIS
NUR FARAHIN AHMAD FAISHALAMIRAH MOHAMED TAHIR
Hospital Sultanah Aminah, JohorSUZANA RAHILA RAMLI
Hospital Sultan Ismail, JohorADNIN ADAWIYAH MAKHUL
NOOR AZEDAH MAHNO
Hospital Sibu
YAP LINGKONG MEE ANG
Hospital Umum Sarawak
CHONG TUANG SIANGNELSON PATRICK
DARYL FERNANDEZ TIMBAN BEALYMASSELLENY GAY ANAK JOSHUA GIANG
Hospital Wanita & Kanak-Kanak Sabah
VU OI LING
Queen Elizabeth Hospital II
NORMALAH PUNGGINGMABELLE WONG FUI JIUN
MELANIE CHONG SHU THENG
Queen Elizabeth Hospital I
JUDITH JAMESALVIN BUNDOI
Hospital Sultanah Nur ZahirahABDULLAH SAMEWOI
WAN ROSNIZAWATI BT WAN OTHMAN
Hospital Tunku Ampuan AfzanADIBAH HAMIZA AHMAD SUHAIMEY
Hospital Raja Perempuan Zainab IIALI IQBAL GHAZALI HASNI
WEE BIN HOON
Sarawak General HospitalTAN SIA HONG
Hospital SibuYAP LING
Queen Elizabeth Hospital II
MABELLE WONG FUI JIUN
Hospital Raja Permaisuri BainunKALPANA DEVI BALAGANGATHARAN
Hospital Tengku Ampuan RahimahESTHER GRACE KUPPUSAMY
Hospital Pulau Pinang
YAMUNAH PALANIYANDI
Hospital Seberang Jaya
FRANCIS OOI BEE AI
Hospital Raja Perempuan Zainab II
ALI IQBAL GHAZALI HASNI
Hospital Sultanah Bahiyah
NOR HAFIZA JOHARI
Hospital Selayang
SITI NURLIANA AHMAD ZAMRI
Hospital Kuala Lumpur
SALBIAH ABDUL RAHIM
DR. GOPIRAJAN A/L J. RASAMYSenior Prime Site & Analytics Executive
PRIME SITES NON PRIME SITES
TECHNICAL/ANALYST SCRAMLAH SHUKORAssistant Regional Manager - Central (A)
Hospital SelayangSITI NURLIANA AHMAD ZAMRINUR ASIMAH ZAINAL ABIDIN
NUR AZWIN ISMAIL
Hospital AmpangLOSHINI MOORTHY
MOHD HAFIDZUL MOHD NOHNUR ELIANA ABDUL AZIZNUR AINA ABDUL ROHIM
HAFIZAH AHMAD
HUKMSITI ZURAIRAH MD SAIF
Hospital Tunku Ampuan RahimahTAN POH FONG
ESTHER GRACE KUPPUSAMYSITI AMIRAH ISHAK
NUR SYUHADA MOHDAssistant Regional Manager - Central (B)
Pusat Darah NegaraMURNIYATI MOHD
Institut Perubatan Respiratori (IPR)SITI SURAYA BT ROZAIDI
Hospital Sungai Buloh
CITRA D/O PALANISAMY
Hospital Kuala Lumpur
SALBIAH ABDUL RAHIMMOHANA PRIYA VELEYSAMY
NOOR FARHANA AZHANI MOHAMAD SAEFFEECHONG HOR YAN
NORA DIANA KAMARUZAMANPUTERI AISHAH AMIRAH JAAFAR
SITI NUR OMAIRA RAZALIISMAYANTI ISMAIL
SITE MANAGEMENT
YAMUNAH PALANIYANDIAssistant Regional Manager - Northern
NOR HAFIZA JOHARISenior Study Coordinator
Hospital Sultan Halim
HASLIZA HALIM
KALPANA DEVISenior Study Coordinator
Hospital Sri ManjungSASIKALA SIVA
SITI MAISARAH MOHD MUKSIN
Hospital TaipingNUR FATIN RAIHANAH ABDULLAH
VENOO KUPPUSAMYSITI ZUBAIDAH ARIPIN
Hospital Raja Permaisuri Bainun
ABDUL HAQ NUR HAIZANPUNITHA SOMASUNDRAMSIVANESAN S. SEEVAGAN
Hospital Pulau PinangLIM CHOOI ENG @ GIRLIE ONG
YOGESWARI NAIDU DARMALINGAMFAIZAH BINTI HARUN
YEOH KAI WEN
Hospital Seberang Jaya
FRANCIS OOI BEE AIFATIN ADAWIYAH OOTHMAN SAH
Hospital Sultanah BahiyahZAINAB SHAFIESITI ERTINA ASLINEOH POH TIEW
Placement of CRM Study Coordinators (SCs)as of February 2016
2
12
5
2
27
6
9
11
7
KELANTAN
MALACCANEGERI SEMBILAN
SELANGOR
KUALA LUMPUR & PUTRAJAYA
PERAK
PENANG
KEDAH
PERLIS
JOHOR
PAHANG
2
TERENGGANU
SARAWAK
SABAH
Numbers of CRM Study Coordinators (SCs)as of February 2016
PenangHospital Pulau Pinang 5Hospital Seberang Jaya 1KedahHospital Sultanah Bahiyah 4Hospital Sultan Abdul Halim 1PerakHospital Raja Permaisuri Bainun 4Hospital Sri Manjung 2Hospital Taiping 3
No. of SCsHOSPITALSNORTHERN REGION
Kuala LumpurHospital Ampang 5Hospital Selayang 4HUKM 1Hospital Tengku Ampuan Rahimah 3
CENTRAL (A)
SelangorHospital Kuala Lumpur 9Pusat Darah Negara (PDN) 1Institute Perubatan Respiratori 1Hospital Sungai Buloh 1
CENTRAL (B)
PutrajayaHospital Putrajaya 2Hospital Serdang 4Hospital Tuanku Ja’afar 2Hospital Melaka 3Hospital Sultan Ismail 2Hospital Sultanah Aminah 1
SOUTHERN REGIONNo. of SCsHOSPITALS
PahangHospital Tengku Ampuan Afzan 2KelantanHospital Raja Perempuan Zainab II 2TerengganuHospital Sulatanah Nur Zahirah 2
EAST REGION
SarawakHospital Miri 1Hospital Kota Samarahan 3Hospital Umum Sarawak 5Hospital Sibu 2SabahHospital Queen Elizabeth I 2Hospital Queen Elizabeth II 3Hospital Wanita & Kanak-Kanak Likas 2
SABAH & SARAWAK
TOTAL: 83
TRIAL SITES IN MALAYSIA
Hospitals / Health Clinics
Facts & Statistics About ISR In Malaysia
• Hospital Ampang
• Hospital Bahagia Ulu Kinta
• Hospital Duchess of Kent
• Hospital Kajang
• Hospital Kuala Lumpur
• Hospital Likas
• Hospital Melaka
• Hospital Mesra Bukit Padang
• Hospital Miri
• Hospital Pakar Sultanah Fatimah
• Hospital Permai
• Hospital Pulau Pinang
• Hospital Pulau Pinang
• Hospital Putrajaya
• Hospital Queen Elizabeth I
• Hospital Queen Elizabeth II
• Hospital Raja Perempuan Zainab II
• Hospital Raja Permaisuri Bainun
• Hospital Seberang Jaya
• Hospital Selayang
• Hospital Sentosa Kuching
• Hospital Serdang
• Hospital Seri Manjung
• Hospital Sibu
• Hospital Sultan Abdul Halim
• Hospital Sultan Ismail
• Hospital Sultanah Aminah
• Hospital Sultanah Bahiyah
• Hospital Sultanah Nur Zahirah
• Hospital Sungai Buloh
• Hospital Sungai Petani
• Hospital Taiping
• Hospital Tengku Ampuan Afzan
• Hospital Tuanku Ampuan Najihah
• Hospital Tuanku Fauziah
• Hospital Tuanku Jaafar
• Hospital Tunku Ampuan Rahimah
• Hospital Umum Sarawak
• Hospital Wanita dan Kanak Kanak Likas
• Institut Perubatan Respiratori
• Klinik Kesihatan Ampang
• Klinik Kesihatan Bandar Sungai Petani
• Klinik Kesihatan Buntong
• Klinik Kesihatan Cheras Baru
• Klinik Kesihatan Greentown
• Klinik Kesihatan Lenggong
• Klinik Kesihatan Putrajaya
• Klinik Kesihatan Seremban 2
• Klinik Kesihatan Setapak
• Klinik Kesihatan Shah Alam Seksyen 7
• Klinik Kesihatan Simpang Kuala
• Klinik Kesihatan Tampin
• Klinik Kesihatan Tanglin
• Klinik Kesihatan Bandar Baru Air Itam
• Klinik Pergigian Gunung Rapat
• Klinik Pergigian Putrajaya
• Klink Pergigian Cahaya Suria
• National Cancer Institute
• Pusat Darah Negara
• Sarawak General Hospital Heart Centre
Facts & Statistics About ISR In Malaysia
TRIAL SITES IN MALAYSIA
MOHE Hospitals
• University Malaya Medical Centre • Hospital University Kebangsaan Malaysia• Hospital University Sains Malaysia• Universiti Teknology MARA (UiTM)
Private Hospitals
• Beacon international Specialist Centre• Chiniese Maternity Hospital• Gleneagles Medical Centre, Penang• Lam Wah Ee Hospital• Loh Guan Lye Hospital• Mahkota Medical Centre• Mount Miriam Hospital• National Heart Centre• Nilai Medical Centre
• Pantai Hospital Ayer Keroh• Pantai Hospital Penang• Pantai Medical Centre• Penang Adventist Hospital• Prince Court Medical Centre• Sime Darby Medical Centre• Sunway Medical Centre• Wijaya International Medical Centre
Phase I / BA/BE sites, Pre-clinical andGLP-certified laboratories in Malaysia
Phase 1 / BA/BE Sites
Pre-clinical Labs
• CRW Ampang Hospital• Hospital Ampang• Hospital Kuala Lumpur• Hospital Pulau Pinang• Hospital Raja Permaisuri Bainun• Hospital Seberang Jaya• Hospital Sibu• Hospital Umum Sarawak (SGH)• Hospital University Sains Malaysia• National Cancer Institute• Pusat Darah Negara• Questra Bio-Clinical Research Centre• Sarawak General Hospital Heart Centre
• Cerca Insights Sdn Bhd• Environmental Technology Research Centre (ETRC), Sirim Berhad• Info Kinetics Sdn Bhd• Institute for Medical Research• IPharm Animal Research Facility (IPARF)• Melaka Biotechnology Corporation
GLP Certified Labs• Environmental Technology Research Centre• Info Kinetics Sdn Bhd• Melaka Biotechnology Corporation• Non-clinical Research, Laboratory Animal Resource Unit, Medical Research Centre, Institute for Medical Research
Year
201 new ISR trials were approved in 2015 by the various ECs (94% of CRM's 2015 KPI1).
New ISR Approved by ECs in 2015
201420122011 20132010 2015
250
200
150
100
202
179
157
143
195201
No.
of T
rials
No. of Trials approved byECs in Malaysia in 2015 (Jan – Dec 2015, n=201)
Cardiology trials recorded the highest number of studies in 2014. However in 2015, oncology trials were the highest among all therapeutic areas.
Note: The therapeutic clasification follows the guideline as provided by FDA.
25
20
15
10
5
0
25
21
Cardiology/V
ascu
lar
19
26
Oncology
No.
of T
rials
20142015
11
9
7
5 55 54 444
3 3
55
2 23
22 22 2 221111 1
12
16
Endocrinology
Haemato
logy
Psych
iatry
Infectio
us Dise
ase
6
18
Epidemiology
Nephrology
65
Respira
tory
Rheumato
logy
Geneti
cs
Hepato
logy
Gastro
enter
ology
3
8
Neurology
Opthalmology
Nutritional
Obstetric
s/Gyn
aeco
logy
21
Urology
Vaccin
e
Anaesth
esiology
Paediat
rics (
Metabolic
& Neurology)
Dentis
try
Dermato
logy
Orthopae
dics
1
Immunology
1
Gynae
cology
1
Otolaryn
gology (Ear,
Nose & Throat)
1
Surgical
Kuala Lumpur had the highest number of ISR/IIR hybrid trials followed by Penang and Selangor.
Number of ISR/IIR hybrid trials approvedfor each state in 2015 (n=457)
Note:1. The number reported for each state includes ISR approved for MOH and non-MOH sites, using the data reported monthly by the 13 ECs in Malaysia2. The number represents individual ISR/IIR hybrid at each state; there may be duplicates of the same trial at other states with different PIs.3. 201 new trials were approved in 2015.
IIR = Investigator Initiated Research; ISR = Industry Sponsored Research
10
20
30
40
50
60
70
80
0
75
W.P. Kuala
Lumpur
69
Pulau Pinan
g
67
Selangor
50
Sabah
45
Sarawak
26
Pahan
g
24
Johor
22
Perak
19
Kelantan
16
Ng Sembila
n
12
Kedah
12
Melaka
10
Putrajay
a
9
Teren
gganu
1
Perlis
No.
of I
SR
Top 10 most active sites in 2015
5
10
15
20
25
30
35
40
0
34
Hospita
l Umum Sara
wak
26
Hospita
l Kuala
Lumpur
22
Hospita
l Pulau
Pinang
20
Hospita
l Ampan
g
15
Hospita
l Ten
glu Ampuan Afza
n
12
Hospita
l Raja
Permais
uri Bain
un
10
Hospita
l Quee
n Elizab
eth
9
Hospita
l Raja
Perempuan
Zainab
II
9
Hospita
l .Sela
yang
9
Hospita
l Sulat
anah
Nur Zah
irah
8
Hospita
l Tuan
ku Ja
’afar
7
Hospita
l Sulta
nah Aminah
7
Hospita
l Sulta
nah Bah
iyah
7
Hospita
l Seb
erang Ja
ya
Hospital Umum Sarawak was the most active site in 2015 with 34 trials, followed byHospital Kuala Lumpur (26 trials) and Hospital Pulau Pinang (22 trials).
No.
of T
rials
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