Services

Biostatistics

Headed by Mihir Gandhi

Our highly qualified and experienced biostatisticians and epidemiologists help you with protocol development by navigating the complexities of study design, sample size, randomisation, database standardisation and statistical analysis methods. The team also provides statistical report writing, research manuscript preparation, interim and final analyses. These recommendations have frequently led to high quality deliverables with great efficiency in time and costs. The scientists also support investigators in regulatory approvals and grant proposals. Leveraging biostatistics in the planning stages of the study design, SCRI helps you to accelerate timelines, improve cost effectiveness and quality of the clinical studies. The team has extensive clinical research experience in phase I to III clinical studies. All team members hold advanced degrees (Masters and PhD).

 


Project Management

Headed by Gao Hong

Our project managers plan and manage clinical trials, from study feasibility to close-out. Each project manager acts as a focal point in providing overall guidance and leadership to drive successful coordination of all operational and scientific teams. With their industry experience, they assist Investigators and Sponsors to resolve any emerging critical issues in clinical trials.


Site Monitoring

Headed by Janice Ng

Our Clinical Research Associates deliver high-quality investigator site support that is augmented by extensive therapeutic knowledge and well-grounded training. With an optimised approach to clinical trials, we improve data quality by providing clinical monitoring and site operational support for local and regional studies.


Data Management

Headed by Ng Xuan Hui

Our data managers have significant experience in designing and customising case report forms (CRFs) to your requirements. Study databases are built using electronic data capture (EDC) software and programmed to perform complex checks on collected trial data. The team ensures high integrity and accuracy of data collection through a comprehensive suite of data cleaning and query management services. SCRI’s data management team operates in full compliance with all applicable regulations, including GCP and 21 CFR Part 11.


Research Informatics

Headed by Huang Kuanfu

SCRI has adopted information technology tools to provide you with clear solutions to complex workflows, improving clinical trial productivity. Our qualified systems analysts understand that one size does not fit all – web-based applications, data capture, study and drug management tools are customised to your needs. These powerful IT tools minimise the manual processes in trials. We help you to run faster and more efficient clinical trial at lower operational costs.


Randomisation

Headed by Huang Kuanfu

SCRI’s randomisation services are proven reliable and suit a range of simple and complex randomised clinical trials. Every automated randomisation system is customised to fit your trial and made easier for use. A team of qualified biostatisticians and systems analysts oversees the creation of your randomisation system to meet your needs.


Evidence Synthesis

Headed by Shi Luming

Our evidence synthesis experts conduct systematic literature review and meta-analyses. Through synthesising qualitative and quantitative data from published evidence, they collaborate with Investigators to identify existing knowledge gaps and provide up-to-date evidence. The highly experienced team also assists to write official Cochrane systematic reviews. All team members hold medical and doctorate degrees (MBBS, MD and PhD). Cochrane Singapore is hosted at SCRI and directed by A/Prof Edwin Chan Shih-Yen. Cochrane Singapore supports the mission of Cochrane to promote Cochrane activities in Singapore and the Asian region. It supports the production of high quality systematic reviews through our collaborations and training workshops. Click here to visit the website of Cochrane Singapore.


Pharmacovigilance

Headed by Gao Hong

A medically qualified pharmacovigilance team helps you to manage Investigational Products’ (IP) safety profiling and reporting responsibilities. The team assesses and monitors adverse events, and ensures that the submission of expedited and periodic reports complies with international and local regulatory requirements. SCRI’s pharmacovigilance team provides 24/7 safety coverage for multi-centre and global trials. SCRI also provides medical monitoring service. Our experienced medical monitors are qualified physicians who serve as medical consultants to project teams by providing medical and therapeutic expertise for safety monitoring and medical interpretation of trial data.


Quality Assurance

Headed by Connie Kum

Our quality assurance team ensures that all trials are conducted to the highest standards, in compliance with the Good Clinical Practice (GCP) guidelines, protocols and regulatory requirements. This provides assurance to trial subjects that their rights, safety and well-being are safeguarded. Some of the SCRI’s quality assurance services include auditing trial processes, study sites and facilities.  The team also supports site personnel on pre-inspection and external sponsor audit trainings and preparation.


Study Planning and Budgeting

Headed by Damien Hong

Each new project or request will be followed by our business operations. SCRI strives to understand the project’s requirements and tailors the proposal to meet your trial’s objectives. We also offer contract and budget administrative services.