Study Design, Analysis & Reporting
Headed by Mihir Gandhi
Biostatistics services comprise:
- Design of clinical trials (all phases) and other clinical studies
- Grant and protocol development
- Generation of randomisation lists with appropriate block-size and stratification factors
- Statistical analysis planning and programming
- Statistical report writing and research manuscript preparation
- Consultation and training on study design, execution, analysis and reporting
Evidence-based treatments and practices are critical for optimising patient care using clinical research conducted locally and in other parts of the world. In turn, the quality of evidence depends on study design, sample sizes and conduct of the study. To optimise research efforts, SCRI's Biostatistics department helps clinicals in designing studies, selecting optimal sample size, and synthesising evidence generated from the study results. Since its establishment in the early days of CTERU, the Biostatistics department has supported more than 100 studies, 150 grant proposals, 200 research papers, 200 workshops/seminars, and 1000 research consultations. The department has evolved to become a scientific reviewer for grant agencies, scientific journals, ethics bodies, and pharmaceutical companies. It is also involved in training medical and biostatistics students for study designing and grant proposal writing, thus ensuring that future generations of clinical researchers have the best skills to produce quality studies.
Headed by Shi LumingEvidence Synthesis services comprise:
- Development of systematic methodology to promote evidence-based medicine
- Conducting synthesis of qualitative and quantitative evidence to evaluate efficacy and cost-effectiveness
- Use of systematic reviews to identify knowledge gaps, assess health services and inform decision-making
- Support production of high quality systematic reviews for the Cochrane Collaboration
SCRI's Epidemiology team supports the practice of evidence-based medicine by developing and teaching review methodologies. Our staff have both clinical and research methodology training to ensure the successful conduct of high quality and clinically relevant systematic reviews and evidence syntheses. Through conducting tailor-made and interactive training workshops, we actively contribute our expertise to help clinical researchers in evidence synthesis. In recent years, we have shifted our focus from traditional interventional studies to meet the emerging demand for evidence synthesis in health economic evaluation and diagnostic test accuracy projects. We are also expanding our training and education activities to cover these new emerging interests. Through these endeavours, we hope top encourage more local researchers in contributing to filling in knowledge gaps by taking on impactful systematic reviews.
Health Outcomes Research
Headed by Shi LumingHealth Outcomes Research services comprise:
- Development of high quality study protocols for health outcomes and health economic evaluation projects
- Support of research grant applications
- Support of post-grant activities such as CRF design, data analysis and reporting
- Evaluation of health services programmes
- Development of hospital-based disease registries
Our epidemiology and health economics teams have extensive experience in collaborating with clinical domain experts to develop quality protocols for health outcomes research, health economic evaluation and health technology assessment projects. We advise on all aspects of protocol design to meet regulatory and funding requirements, providing guidance to create a feasible and rigorous study protocol. With our medical training, clinical research foundations and vast research experience, we are the clinicians’ ideal partners to help quickly translate a research question into a valid and feasible research plan. Health outcomes investigations not only improve the potential to provide the best care at the lowest cost to our patients but also influence the formation of healthcare policies relevant to our population’s needs. Currently, the Epidemiology department forms the nucleus of health economic evaluation expertise at SCRI, and we provide technical support to help local clinical researchers incorporate health economic evaluation into their research projects. We are also currently involved in a number of cost-effectiveness analyses alongside clinical trials in different therapeutic areas. In addition, we are expanding our training services to cover emerging fields in health outcomes research and health technology assessment, such as health services evaluation and diagnostic test accuracy research. With these initiatives in place, we hope to equip local researchers to meet the future demand for knowledge on patient outcomes and value-added health services.
Study Planning & Budgeting
Headed by Damien HongBusiness Operations services comprise:
- Customised study proposals that meet trial objectives of partners
- contract and budget administration services
- Effective Communication between internal and external stakeholders
The Business Operations department often represents SCRI in reaching out to collaborators to share SCRI's expertise. The team supports our partners in the planning of their studies and budgeting processes by understanding clearly the collaborators' requirements, and offering customised project proposals. As the coordinator between internal and external stakeholders, Business Operations also advises on the proposed workflows based on collaborators' needs and requirements. Effective coordinations and communication is key in managing expectations of stakeholders. By reaching out to partners, the team works closely with them to ensure that SCRI's proposed services not only meet partners' needs but also fit their proposed budgets and finalised contracts. For partners applying for research grants to fund studies, the team is also equipped with the facility to assess operational needs and proposed budgets required for grant submissions.
Project ManagementHeaded by Gao Hong Project Management services comprise:
- Planning and organisation, monitoring and control of clinical research projects from study feasibility to close-out
- Protocol preparation and implementation
- Study budget preparation
- Oversight for protocol compliance, adherence to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guideline and standard operating procedures
- Study progress reporting
- Management and review of times, budget and deliverables
- Primary contact point throughout study
Good communication is vital. We know that they key to a successful project is in identifying study requirements and addressing the needs, concerns and expectations kif the stakeholders in planning and executing the project. At SCRI, we support the sponsor and Principal Investigator (PI) so they can focus on what really matters, patient care. By managing the set-up, running and closing of a clinical trial, project managers ease the workload of the study team. We enable sponsors and PIs to make sound decisions by overseeing communication with internal and external stakeholders, obtaining regulatory requirements and study updates, and presenting these as digestable reports. SCRI's Project Management expertise provides critical project oversight from project planning to study close-out, ensuring effective communication with stakeholders and maintaining project stability. The team at Project Management realises benchmarks of clinical study excellence via protocol development, feasibility assessment and site evaluations. The department also works closely with stakeholders for the development of study guides like the Monitoring Plan and Study Operations Manual, on top of regularly reviewing budget and timelines to identify potential overruns. Successful clinical research is a complex combination of multiple strengths. The project manager has a pivotal role in guiding study teams to work together towards common goals, overcome cultural variances and optimise work processes. The team is committed to supporting clinical research excellence for better treatments for our patients. We seek to have all our project managers certified as Project Manager Professionals (PMP), developing thought leadership and expertise in managing multi-national, multi-centre, investigator-initiated trials. Establishing a central database to consolidate our project knowledge and data over decades will also ensure strength in business continuity.
Headed by Huang Kuanfu
Research Informatics services comprise:
- Recommendations of IT solutions and support for sustainable clinical research operations that help reduce operational costs of clinical trials
- Provision of a Data Centre, including computer systems hosted on a high-speed, secure network with 24/7 network monitoring, back-up redundancy and compliance with regulatory requirements
- Application of informatics principles and techniques to support clinical research processes that meet study requirements and ensure compliance with regulations
- Development and use of new or customised information technology tools to facilitate complex clinical research workflows and sustainable operations
- Development and customisation of software tools and processes to enhance communication with stakeholders
- Sourcing and adoption of new technology to support study designs in accordance with industry best practices
Good communication is vital. We know that the key to a successful project is in identifying study requirements and addressing the needs, concerns and expectations with the stakeholders in planning and executing the project. At SCRI, we support the sponsor and Principal Investigator (PI) so they can focus on what really matters, patient care. By managing the set-up, running and closing of a clinical trial, project managers ease the workload of the study team. We enable sponsors and PIs to make sound decisions by overseeing communication with internal and external stakeholders, obtaining regulatory requirements and study updates, and presenting these as digestable reports. SCRI's Project Management expertise provides critical project oversight from project planning to study close-out, ensuring effective communication with stakeholders and maintaining project stability. The team at Project Management realises benchmarks of clinical study excellence via protocol development, feasibility assessment and site evaluations. The department also works closely with stakeholders for the development of study guides like the Monitoring Plan and Study Operations Manual, on top of regularly reviewing budget and timelines to identify potential overruns. Successful clinical research is a complex combination of multiple strengths. The project manager has a pivotal role in guiding study teams to work together towards common goals, overcome cultural variances and optimise work processes. The team is committed to supporting clinical research excellence for better treatments for our patients. We seek to have all our project managers certified as Project Manager Professionals (PMP), developing thought leadership and expertise in managing multi-national, multi-centre, investigator-initiated trials. Establishing a central database to consolidate our project knowledge and data over decades will also ensure strength in business continuity.
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.
Research MonitoringHeaded by Janice Ng Research Monitoring services comprise:
- Coordination and conducting of site initiation visits
- Customisation of project templates in accordance with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guideline
- Provision of training for investigators and site personnel
- Monitoring of clinical trials according to the monitoring plan in compliance with the approved protocol, regulatory and Institutional Review Board (IRB) requirements, sponsor guidelines and GCP. Monitoring includes source document verification, protocol and GCP compliance checks, safety, operations and essential document review, investigational product and lab sample reviews
- Facilitation of communication with project stakeholders including clients and trial sites
- Close-out visits after the completion of clinical trials with processes ranging from documentation reviews to archival of clinical trial data documents
The Research Monitoring team takes part in both local and international clinical trials, and it is staffed by trained Clinical Research Associates (CRAs) with accreditation from the Association of Clinical Research Professionals. SCRI’s CRAs collaborate closely with internal study teams and external stakeholders, driving the production of quality research data for local and regional clinicians. Our department has diverse experience in the provision of monitoring services for different therapeutic indications, including oncology, infectious disease, metabolic disease and cardiology. Our CRAs are trained to ensure that trials are conducted, recorded and reported in accordance with protocol, SCRI SOPs, GCP and the applicable regulatory and IRB/IEC requirements. Our CRAs undergo certification examinations by the Association of Clinical Research Professionals (ACRP) as part of their career progression. Their continual training ensures constant development of their technical knowledge and monitoring proficiency ahead of an evolving clinical trial landscape. CRAs train investigation site personnel to meet study requirements and also conduct regular site monitoring visits to enhance operational efficiency and consistency of the projects at hand. Our CRAs’ expertise has taken them to countries ranging from Brunei, Hong Kong, Malaysia, Mongolia, Myanmar, New Zealand, Thailand, Philippines, South Korea, Taiwan and Saudi Arabia. The team understands that building rapport with site collaborators is vital to efficiently resolve site issues together. Communication is key so that timely delivery of project plans and milestones are maintained while adapting to guidelines, regulatory requirements, working culture and environment variances. On-site monitoring visits by CRAs ensure that the rights and well-being of trial patients are protected. This is achieved via verification of trial patient data as well as examination of quality compliance to GCP, regulatory requirements, SOP and the approved protocol.
Data ManagementHeaded by Ng Xuan Hui Data Management services comprise:
- Creation and design of Case Report Forms (CRF) based on requirements of clinical trial protocol
- Design and development of study database
- Design and writing of data validation programmes for complex clinical data checks
- Development of CRF Completion Guidelines
- Data cleaning and query management to ensure integrity and accuracy of study data
- Training of study site personnel in data entry skills to ensure quality of study data
- Clinical Data Management System (CDMS) known as Oracle Clinical (OC), with a Remote Data Capture (RDC) application that allows data to be recorded directly at study sites
- Medical coding such as dictionary coding to enable classification of medical events and medications under the rules of established dictionaries (e.g. MedDRA and WHO Drug Dictionary)
- Use of business analytics and intelligence software called SAS Enterprise Guide for reporting of comprehensive data matrices
Specialised skills in Data Management are a rarity in Singapore’s clinical research scene. To adequately support internal and external stakeholders in clinical research, SCRI’s Data Management team offers system training and skilful planning to ensure the integrity of data during a study. Efficiency and intuitive usage of data management systems are also important towards streamlining the data gathering process, and the team strives to support this via development of electronic Case Report Forms (CRF) and project guides such as the RDC Users’ Self Help Guide. Validated international dictionaries such as the MedDRA and WHO Drug Dictionary are utilised to standardise medical terminology and drug names used in a study database. When in place, these measures help to ensure a common language and stability throughout a study. Besides driving productivity at study sites, site staff can invest more time with study subjects instead of keying large quantity of information into the database. To ensure that study data is thoroughly assessed, a comprehensive data management plan and study data matrices reports for principal investigators and project managers can be generated by the Data Management team. The team utilises the Oracle Clinical system to manage clinical studies and systemise the keying of information into databases. For added focus during collection of data variables for analysis, user guides such as the CRF Completion Guidelines can be established. It is important to sustain a pool of talents in the furtherance of clinical research excellence for the future. In light of this, the department has an ongoing partnership with Nanyang Polytechnic to provide internship programmes and introduce youths to a fulfilling Data Management career path in clinical research.
PharmacovigilanceHeaded by Gao Hong Data Management services comprise:
- Review of all Serious Adverse Events (SAEs) in a study, and performance of safety analysis
- Processing of individual cases and assessment of investigational products
- Safety reporting to regulatory authorities and other stakeholders
- Provision of round-the-clock safety coverage
SCRI’s Pharmacovigilance team plays an essential role in product development, specifically providing safety support to investigator-initiated trials in order to achieve their full potential to provide quality healthcare. The Pharmacovigilance team designs trial-specific SAE forms and safety monitoring plans which establish the safe use of investigational products, reduce risks and increase benefits for patients. In collaboration with principal investigators of a study, the Pharmacovigilance team creates a centralised database to capture and monitor SAEs while ensuring timely identification of events that qualify for expedited reporting if necessary. The team also communicates closely with all site and study teams to provide medical support, consultation on SAE reporting, as well as training for SAE reporting, processes and timeline. Other key services by the Pharmacovigilance team include performing SAE reviews and queries, coordinating with the investigational site to assemble SAE report packages, and carrying out SAE reconciliation. The team is trained in managing the complexities of multi-national and multi-centre trials, such as language and culture barriers, to meet the requirements of international pharmacovigilance regulations. The Pharmacovigilance team safeguards patient safety standards for drugs and medical devices. It delivers the expertise of moving a new drug or device from conception to marketing stages while keeping headcount lean in today’s multifaceted clinical trials.
Quality AssuranceQuality Assurance services comprise:
- Performing clinical audits to evaluate trial conduct and compliance of the trial to (1) protocol, (2) the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guideline, (3) applicable requirements of the regulatory authority and Institutional Review Board/ Independent Ethic Committee (IRB/IEC) and (4) sponsor’s and SCRI’s standard operating procedures (SOPs)
- Conducting pre-audit/pre-inspection preparation for site personnel and clinical operations staff, and providing on-site support activities during audits and inspections
- Training of site and clinical operations staff to meet requirements of audits from the institution, sponsor or health authority inspections
- Providing GCP consultation and guidance to stakeholders
- Fulfilling of QA services for external clients i.e. conducting onsite audit and inspection preparation
The Quality Assurance department works closely with sponsors and local regulatory authorities for inspections and audits of clinical trials and their sites, ensuring that clinical studies are conducted with compliance to approved protocols, guidelines and regulations. With the ability to provide quality management services for clients, including conduct of on-site GCP audits, the department builds quality into clinical trials by establishing internal SOP processes, while keeping project stakeholders abreast of evolving regulatory requirements. For the purpose of human subject protection and study data quality, the department highlights the importance of research compliance and builds awareness of auditing requirements and procedures. Safeguarding the effectiveness and relevance of quality management activities is key. The Quality Assurance team keeps up with the evolving regulatory climate for clinical trials involving drugs and medical devices to ensure that its processes and procedures adapt to changing guidelines. Quality Assurance is fundamental to establishing the merits in the delivery of SCRI’s core services, ensuring protection of human study subjects and reliable data returns. Building quality by design can help ensure that all aspects of the trial are operationally feasible with reduced complexity, thereby improving the efficiency and quality of the trial. With the introduction of the new integrated addendum to ICH E6(R1) of the GCP Guideline, there is increased focus on quality management systems using a risk-based approach. The Quality Assurance team is exploring the potential of a quality management system that can be applied throughout all stages of the trial process so as to enhance efficiency and operational feasibility of investigator-initiated trials.