Clinical Research Centre
Hospital Melaka
Melaka
WhoWe Are
The Clinical Research Centre Hospital Melaka (CRC HM) started its service in 2007 until 2011, it was located at the main building in a room in the Department of Medicine. CRC HM then moved to its current site to a repurposed bungalow unit. On 5 November 2012, this unique CRC building was officially opened. In our new premise, we have expanded our services & facilities.
OurTeam
InvestigatorsHighlight
Head of CRC, Medical Specialist, Hospital Melaka
Email: drshalinivn@moh.gov.my
MBBS, MRCP (UK), MRCPS (Glasg), FRCP (Glasg), AM
Awards and achievements:
- Excellent Service Award, Ministry of Health Malaysia (2012, 2016, 2021)
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PMC - Pingat Masyarakat Cemerlang by the Royal State Ruler of Negeri Sembilan (2006)
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Certified Medical Impairment Assessor (CMIA)
Dr. Shalini is a specialist in Internal Medicine with the Department of Medicine Hospital Melaka. She also serves as the Head of CRC Hospital Melaka. Apart from being a clinician, she has had extensive expertise and experience in clinical research and has been actively involved in multiple research projects as principal/sub investigator. Besides conducting research, Dr. Shalini oversees the consultation, training and management of Industry-Sponsored Research (ISR) and Investigator-Initiated Research (IIR) in CRC Hospital Melaka. She has also published articles in both local and international journals.
Research Highlights
- Principal Investigator for: TILIA, SUSTAIN8, PIONEER6, DEVOTE, XALIA-LEA, SONAR, SKF-7 OBESITY TRIAL
- Co-Investigator for: AMGEN, SUSTAIN6, BI-1288, MAVERIK, WHO SOLIDARITY, I-TECH, FAVI, Dengue TIDREC
| NMRR-16-2814-29003 (IIR) | Multi- Center Field Trial of a Diagnostic Kit for the Identification of Potential Severe Dengue |
| NMRR-19-3639-50718 | ADOPT: A multinational, randomized open-label, parallel group, active-controlled, two-arm, long-term morbidity and mortality trial involving intensive preventive therapy (high dose renin-angiotensin-aldosterone system inhibitors [RAASi], beta-blockade, sodium-glucose co-transporter 2 inhibitors [SGLT2i]) among biomarker (N-terminal pro-B-type natriuretic peptide, NT-proBNP)-identified high risk type 2 DM patients without pre-existing cardiovascular disease |
| NMRR-22-01696-ACA | EXT TCH-306 (foresight) : A Multicenter, Open-Label, Extension Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults with Growth Hormone Deficiency |
| NMRR-22-02592-LFW | APEX: A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab in Improving the Signs and Symptoms and Inhibiting Radiographic Progression in Participants with Active Psoriatic Arthritis. |
| NMRR-22-02520-G4P | TILIA: A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab (MEDI3506) in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen |
| NMRR-23-02546-OLS | AJAX: A Phase 2a Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AZD4604 Twice Daily for Twelve Weeks in Adult Patients with Moderate-to Severe Asthma Uncontrolled on Medium-High Dose ICS-LABA |
| NMRR-23-02718-WNX | BaxHTN: A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Baxdrostat in Participants with Uncontrolled Hypertension on Two or More Medications including Participants with Resistant Hypertension |
| NMRR-23-03227-9DZ | REDEFINE3: The cardiovascular safety of cagrilintide 2.4mg s.c. in combination with semaglutide 2.4mg s.c (CagriSema 2.4mg/2.4mg s.c.) once weekly in participants with obesity and established cardiovascular disease |
| NMRR-23-00525-RKY | VICTORION - 1 PREVENT: A randomized, double-blind, placebo controlled multicenter study to evaluate the effect of inclisiran on preventing major adverse cardiovascular events in high-risk primary prevention patients |
| In NMRR registration process | CKD (NN9541-7841): Efficacy, safety and pharmacokinetics of NNC0519-0130 once weekly s.c. versus semaglutide 1.0 mg and placebo in people with chronic kidney disease, with or without type 2 diabetes, and with overweight or obesity: a proof-of-concept and dose-finding study |
Services at CRC Hospital Melaka
CRC HM provides training through workshops and consultations:
- NMRR registration
- Discussion on MREC Feedback
- Statistical Consultation
- Protocol/Proposal Development
- Literature Search
- Review of Research Protocol
- Manuscript Write-up
- Assist in submission for Grants and Publications.
- We also provide trainings such as: Good Clinical Practice (GCP) Basic Proposal Writing Research Methodology Sampling Technique & Sampling Size Calculation Basic Statistics Academia Information Seeking & Reference Manager Scientific Poster & Oral Presentation NMRR & Library Services Roadshow Continuous Medical Education (CME) Others.
CRC Hospital Melaka
Email: melaka_crc@moh.gov.my
Phone number: +606-289 2195 / 2182
