We are ISO 9001:2015 certified!

We are delighted to announce that Clinical Research Malaysia is now ISO 9001:2015 certified!

ISO 9001 is the most widely used and recognised standard for Quality Management System internationally. To become ISO 9001:2015 certified, Clinical Research Malaysia has met the requirements set out in and have been audited by SIRIM QAS International Sdn Bhd in accordance with the 9001 standard.

It is an achievement that shows our commitment to become a global trusted company.

PhAMA Industry Fact Book: 2018 Edition

Clinical Research Malaysia has contributed our insights for Industry Sponsored Research (ISR) in the Pharmaceutical Association of Malaysia (PhAMA) Industry Fact Book: 2018 Edition (pg. 74 – 80) which was launched by Health Minister Datuk Seri Dr Dzulkefly Ahmad on 8 January 2018.

Download the latest PhAMA Industry Fact Book: 2018 Edition today!

 


 

 

 

Director-General of Health, Malaysia Visit to CRM New Office

We received a visit by YBhg. Datuk Dr. Noor Hisham Abdullah, Director General of Health, Ministry of Health, Malaysia earlier this morning to our new office located at Menara SuezCap, KL. Thank you Datuk, for your the great support in clinical research and visiting us!

Malaysia Pharma Report 2018

Through exclusive interviews with the Malaysian Minister of Health as well as the head of the country’s regulatory body – the NPRA – this report examines emerging trends in Malaysian healthcare, with Prime Minister Tun Dr. Mahathir Mohamad spearheading a bold health policy reform.

Also explored is the emergence of the halal medicine niche – where Malaysia has the potential to be a global leader given its geographic links to Southeast Asia and cultural ties to the Middle East – the first Malaysian biosimilars, the country’s outstanding potential as a regional clinical research hub and the rise of medical tourism.

Malaysian breakthrough in clinical study on ovarian cancer blood test – BERNAMA

Dr. Akhmal Yusof, CEO of Clinical Research Malaysia.

KUALA LUMPUR: Malaysia is the first country in Asia to start clinical study of ovarian cancer diagnostic blood test in early 2019, said chief executive officer (CEO) of Clinical Research Malaysia (CRM), Dr. Akhmal Yusof.

This is following an institutional investment of RM39 million by InterVenn BioSciences, a biotech company based in USA to develop the cancer early detection blood test in collaboration with CRM and Technology Park Malaysia (TPM).

TPM acting president/CEO, Sharbani Harun said that the collaboration marked an important milestone for Malaysia to become a central hub for the Asia-Pacific region, towards the advancement of research and development in the field of biomedical and life sciences.

Meanwhile, Dr. Akhmal added InterVenn’s decision to conduct clinical study here is a testament to the country’s capabilities in terms of infrastructure, good clinical practice, certified investigators and a large patient pool.

Once clinical validation and regulatory processes are completed, the ovarian cancer blood test will be offered as a laboratory diagnostic test.

The investment is led by San Francisco-based biotech investor Genoa Ventures, with participation from True Ventures, Amplify Partners, Boost VC and Prado SV.

InterVenn has also established subsidiaries in Kuala Lumpur and Manila to foster biotechnology, drive AI adoption and support Industrial Revolution 4.0 in Southeast Asia.

– Bernama

We have moved to new office!

Clinical Research Malaysia has now moved to our new office to provide better service for clinical research. We now operate from:

D-26-06, Menara Suezcap 1,
KL Gateway, No. 2 Jalan Kerinchi,
Gerbang Kerinchi Lestari,
59200 Kuala Lumpur.

We could be contacted through:

Phone number: +603 7931 5566
Facsimile number: +603 7931 9940

Our individual team member emails remain unchanged and if you need further clarification you could write to contact@clinicalresearch.my

We appreciate your continuous support and look forward to continuing growing clinical research in Malaysia together from the new office.

 

Sincerely,
The Management of CRM

Silicon Valley-Based InterVenn BioSciences Raises RM 39 Million, Establishes Subsidiary in Malaysia to Develop Ovarian Cancer Early Detection Blood Test in Collaboration with TPM and CRM

KUALA LUMPUR, Dec 14 (Bernama) — InterVenn BioSciences, a biotech company innovating cancer diagnostics using Artificial Intelligence (AI) and next-gen mass spectrometry, announced this week an institutional investment of US$9.4 million led by San Francisco-based biotech investor Genoa Ventures, with participation from True Ventures, Amplify Partners, Boost VC, and Prado SV.

Headquartered in Silicon Valley, USA, InterVenn has established subsidiaries in Kuala Lumpur and Manila to foster biotechnology, drive AI adoption, and support Industrial Revolution 4.0 in Southeast Asia. The company is conducting analytical and clinical validation of its ovarian cancer diagnostic blood test. A global, multi-site clinical study to validate this test will commence in early 2019. Clinical Research Malaysia (CRM), an agency under the Malaysia Ministry of Health, plays a vital role in supporting InterVenn’s clinical operations in Malaysia and facilitated fifteen clinical sites across nine states in Malaysia for this clinical study.

InterVenn’s established strategic partnership with Technology Park Malaysia (TPM) in 2017, an agency under the Malaysia Ministry of Energy, Science, Technology, Environment and Climate Change (MESTECC), to build an internationally-certified clinical laboratory, attract and upskill a critical scientific talent pool in Malaysia.

Once clinical validation and regulatory processes are completed, the ovarian cancer blood test will be offered as a laboratory diagnostic test. “Today, early diagnosis of ovarian cancer is extremely poor, despite its role in significantly improving survival rates,” said Aldo Carrascoso, CEO of InterVenn BioSciences. “We’ve established a talented team of experts in AI, computational biology, mass spectrometry, glycoproteomics, and product development who are dedicated to equipping physicians with a reliable tool to change the narrative around ovarian cancer. ”

“InterVenn’s decision to conduct their clinical study in Malaysia is testament to the country’s capabilities in terms of infrastructure, good clinical practice, certified investigators and a large patient pool,” said Dr. Akhmal Yusof, CEO of Clinical Research Malaysia. “InterVenn can capitalize on the services that CRM provides to ensure smooth conduct and delivery of their trials. I’m proud that Malaysia will be the first country in Asia that will start this clinical study next year and hopefully Malaysia can contribute to InterVenn’s exponential growth further in the near future.”

Meanwhile, TPM Acting President/CEO, Encik Sharbani Harun said that the collaborative efforts between InterVenn and TPM marked an important milestone for Malaysia to become a central hub for the Asia-Pacific region, towards the advancement of research and development in the field of biomedical and life sciences. “We are certainly proud to be given the opportunity to work closely with InterVenn whereby they will be the utilizing our world-class laboratory equipment and facilities to further their cancer diagnostic innovation,” added Sharbani.

InterVenn aims to lead the next wave of precision medicine by enabling innovation in diagnostics and therapeutics through global collaborations to improve human health. The partnership with TPM and CRM serve as a launchpad for this mission.

–BERNAMA

CRM Becomes First Southeast Asia Research Organisation to Join IQVIA’s Global EPON

Seating L-R: Mr. Teck Kwang Koh, General Manager at IQVIA Malaysia and Dr. Akhmal Yusof. Standing L-R: Dr Voon Pei Jye, Mr. Desmond Dorairajoo, Dato’ Dr. Goh Pik Pin and Mr. David Horsburgh.

KUALA LUMPUR, 28 November 2018 – Clinical Research Malaysia (CRM) today signed a memorandum of understanding (MoU) to establish a strategic alliance with IQVIA’s global Early Phase Oncology Network (EPON).

The agreement makes Clinical Research Centre at Sarawak General Hospital the first in Southeast Asia to be part of IQVIA’s prestigious network of globally qualified Phase I oncology sites. CRM, established by the Malaysian Ministry of Health in 2012, exists to advance Malaysia’s ability to contribute to global health solutions. IQVIA is a leading global provider of contract research services, advanced analytics and technology solutions to the life-sciences industry.

“This agreement is a major step forward for the country of Malaysia to provide advanced Phase I studies for investigational cancer therapies,” said CRM Chief Executive Officer Dr Akhmal Yusof.  “Advances in genomics offer new hope for targeted oncology products. Through this agreement, Sarawak General Hospital will join IQVIA’s global Early Phase Oncology Network, which is designed to provide fast, high-quality Phase I oncology studies to biopharmaceutical companies.”

IQVIA Asia Pacific President Anand Tharmaratnam said: “This agreement builds upon our long relationship with Clinical Research Malaysia as an IQVIA Prime Site.  Adding Sarawak General Hospital’s research centre gives biopharma companies, for the first time, a Southeast Asia location as part of IQVIA’s global network of high quality early phase oncology research sites.  This is a significant step forward in our joint mission to accelerate the development of targeted oncology therapies in Malaysia and Asia for the benefit of patients worldwide.”

IQVIA has been conducting oncology early clinical research in Asia Pacific for more than two decades.  The IQVIA EPON-Clinical Research Malaysia strategic alliance is designed to streamline study startup, enhance consistency, and deliver high-quality results faster.

This collaboration is intended significantly improve the quality of early phase oncology trials in Malaysia by having innovative investigational therapies as an option for patients. This aligns with the Phase I Realization Project (P1RP) that was launched by CRM in 2016 which is focused in enhancing Malaysia’s early phase clinical research capacity and building a more attractive early phase clinical research ecosystem.

The MoU is signed between Dr Akhmal Yusof and on behalf of IQVIA, Mr. Teck Kwang Koh, General Manager at IQVIA Malaysia. The signing of the MoU was witnessed by the Director of Network of Clinical Research Centre, YBhg. Dato’ Dr. Goh Pik Pin, Dr Voon Pei Jye of Sarawak General Hospital, Mr. Desmond Dorairajoo, Head of Academic Research Group Asia-Pacific IQVIA and Mr. David Horsburgh, Asia Strategy Lead, Academic Research Group Asia-Pacific IQVIA.

About CRM

Established by the Malaysian Ministry of Health in 2012, CRM exists to advance global health solutions for a brighter, more hopeful future for the people by providing speedy and reliable end-to-end clinical research support for quality studies. CRM’s innate understanding of the local clinical research landscape with the international standards of operations coupled with fundamental backing of the government ministries provide us an incomparable advantage to work with partners from the nascent stages of development to materialisation of the end product, in order to deliver better treatment and high skilled job opportunities.

 

About IQVIA

IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. Formed through the merger of IMS Health and Quintiles, IQVIA applies human data science — leveraging the analytic rigor and clarity of data science to the ever-expanding scope of human science — to enable companies to reimagine and develop new approaches to clinical development and commercialization, speed innovation and accelerate improvements in healthcare outcomes. Powered by the IQVIA CORE™, IQVIA delivers unique and actionable insights at the intersection of large-scale analytics, transformative technology and extensive domain expertise, as well as execution capabilities. With more than 55,000 employees, IQVIA conducts operations in more than 100 countries.To learn more, visit www.iqvia.com.

BERNAMA

Hospital Sibu Top 5 Recruiter Globally for Respire RSV Study

Dr. Toh Teck Hock and his clinical research team has set another milestone in Hospital Sibu, Sarawak for the Respire RSV study recently as they are the world’s top 5 recruiter in the Respire RSV study.

“Although Sibu has a number of queries (which is normal), but our Study Coordinators (SC) were fast to resolve those queries. To me it shows the “Quality” work our SC has done (Of course, the Co-I has to be good too)” – Dr Toh Teck Hock, Head of Clinical Research Centre, Hospital Sibu.

We would like to congratulate Dr. Toh and his team in Hospital Sibu for the great achievement!

Check out CRM Bulletin Issue 15 as we featured Dr. Toh recently, to find out more about Dr Toh visit https://clinicalresearch.my/research-personality-dr-toh-tec…/

Read more contents from CRM Bulletin Issue 15. Download here!

Japanese Pharmaceutical Companies Show Interest to Conduct Clinical Trials in Malaysia

TOKYO, 6 November 2018 – Clinical Research Malaysia (CRM) hold a half-day seminar that targets Japanese pharmaceutical and medical device companies interested in conducting clinical trials in the Asian region. This is the first time for CRM to deliver a clinical trial seminar focusing on its home country in Japan.

Read more