> About Us
Who we are
Siriraj Institute of Clinical Research (SICRES) is an academic clinical research institute, operating under the Faculty of Medicine Siriraj Hospital, Mahidol University.
Our Mission
Our Vision
Our Goals
o Sustained collaboration with our partners
o Cutting edge research that advances clinical practice
o Cost-effective services that bring value to our clients
o Effective and timely communication of our findings
What we do ?
SICRES conducts cost effective clinical research at international standards and offers full-service clinical trial design and management.We offer a suit of capacities and services including
o Experienced investigators and highly trained clinical research staffs
o Precision clinical trial design and management (Phase I to IV)
o Bioequivalence studies, Feasibility surveys, Safety and Efficacy evaluations
o Integrated database development and biostatistical analysis
o Training and development of research staffs
o High impact medical publications and presentations
o Patient safety and adverse event monitoring
o A national and international research network
o Grant application support for investigators
Our Facilities
SICRES offers modern facilities that meet or surpass international standards. Our 30-bed research unit can accommodate overnight studies and has a synchronized clock system to assure protocol compliance. Each bed has a nurse call system, private restroom and 24-hour CCTV monitoring.
We have a comfortable patient waiting area, five examination rooms and a treatment room. SICRES also offers a secure conference room and private monitoring systems for investigators, sponsors and auditors. We maintain a secure filing and data archiving system to protect your data and assure patient confidentiality. We also operate separate fax systems for blinded and unblinded study staff. SICRES offers state of the art laboratory facilities including two 2-8°C, four sub 25°C refrigerators, one -20°C and three -80°C freezers.
All storage systems are maintained in 24-hour air-conditioned rooms with electronic remote notification of temperature variance. We have four refrigerated centrifuges, multiple biosafety cabinets and an emergency trolley equipped with a defibrillator and a 12-lead EKG.
Services
Clinical Research Services
SICRES offers a full spectrum of clinical research services to bring about new and innovative solution and findings. Our services cover the entire clinical research and development that can be tailored to national and international trials.
Feasibility Studies
Support the sponsors/CROs to evaluate the possibility of conducting a particular clinical trial at Faculty of Medicine, Siriraj Hospital or in a particular geographical region with the overall objective of optimum project completion in terms of timelines, targets and cost.
Study Planning and Budgeting
Supports our investigators/partners in the planning of their studies and budgeting processes by clearly understanding the collaborators’ requirements and offering customized project proposals.
Contract Management
Assist the sponsors/CROs by facilitating Clinical Trial Agreement (CTA) process.
Payment Management
Supports financial accountability on the basis of transparency, traceability and auditability.
Complete records of all financial transactions are maintained, making financial audits simple and easy.
IRB/IEC and Regulatory Submission
Support sponsors/CRO on preparation of clinical research dossiers for submission to Regulatory Authorities.
Assist investigators on the Institutional Review Board (IRB) / Independent Ethics Committee (IEC) submission.
Bioequivalence Center
30-bed clinical research facility well-equipped to conduct BE trials – whether on small molecule drugs or biosimilars – as well as phase 1 and early phase trials.
Supporting generic drug manufacturers in planning, initiating, and completing their BE trials fulfilling the regulatory requirements.
Clinic Facilities
Equipped with dedicated clinical research facilities for supporting ICH-GCP- standard clinical studies.
All such research facilities are properly maintained and are operated by professionally qualified and trained personnel.
Investigational Product Management
Support investigator on the investigational product management in conformity with Good Clinical Practices (GCPs).
Strictly controlled units accessible only to authorized pharmacists, dispensers, and study drug management personnel.
All study drug refrigerators are monitored by temperature data loggers and supported by emergency electricity backup, uninterrupted power supply and round-the-clock monitoring and alarm system.
Sample Management
Equipped with regularly calibrated and properly maintained equipment for supporting biological specimen management services.
Biosafety cabinet, refrigerated centrifuges and incubator are available for processing of specimens. All medical freezers are connected to 24-hour monitoring and alarm systems and supported by emergency power supply.
Data Management
Provide highly professional, rapid, and exacting clinical data management services.
Our experienced staff assure the reliability of study’s data.
Statistical Analysis
Provide all-encompassing support, from consultation on the development of the statistical analysis plan to the creation of the statistical analysis report,
Perform statistical analyses to assess collected data objectively.
Medical Writing
Provide medical writing support for every stage in product development, from protocols, informed consent forms (ICF) to clinical study reports (CSR).
Clinical Operations
Our clinical operation services include: feasibility, site selection, contract negotiation and execution with clinical sites, clinical monitoring, supplying and retrieving investigational products, collection and checking case report forms, and processes for clinical studies closeouts.
Project Management
Provides skilled project management support for timely delivery of project milestones and performance targets for clinical trials.
Coordinate all aspects of the study closely with the sponsor and team.
Training and Education
Organizes various training programs for investigators, study coordinators, study nurses and other research staff to improve their capabilities to perform clinical trials.
Manuscript editing service
Polish a manuscript draft until it is ready to submit. Consultation service for writing medical articles is also provided.