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SICRES : Siriraj Institute of Clinical Research

Your Success Is Our Success

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SICRES Business Report 2019-2022

อ่านรายงานทางธุรกิจประจำปี 2019-2022 ของศูนย์วิจัยคลินิกได้ที่นี่ SICRES Business Report 2019-2022 Now Ready to Download

Basic Study Coordinator Training

ชมภาพบรรยากาศการอบรม Basic Study Coordinator ซึ่งจัดขึ้นในวันที่ 14-16 มีนาคม 2566 ที่ผ่านมา ณ ตึก SiMR ชั้น 12 คณะแพทยศาสตร์ศิริราชพยาบาล

อัพเดตผลการฉีดวัคซีนโควิดเข็ม 4 เข้าชั้นผิวหนังและกล้ามเนื้อในผู้สูงอายุคนไทย

อ่านผลการศึกษา การฉีดวัคซีนเข็มที่ 4 เข้าชั้นผิวหนังและชั้นกล้ามเนื้อในผู้สูงอายุคนไทย พร้อมข้อสรุปและคำแนะนำ

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. 

SICRES | ˈsīkres | , ไซ-เครส

"Your Success Is Our Success"

Our Mission

SICRES keen to conduct and support clinical research for the benefit of community to transform patient care and improve human health.

Our Vision

SICRES aims to become the most trusted academic clinical research organization in Southeast Asia.

Our Goals

A vibrant and patient-focused
research program

Sustained collaboration with partners

Cutting edge research that advances clinical practice

Cost-effective services that bring value to our clients

Effective and timely communication of our findings

Our QUALITY POLICY

SICRES QUALITY POLICY
Read more...

Meet the Director

Professor Kulkanya Chokephaibulkit
Director

SICRES Management

Assoc. Prof. Winai Ratanasuwan

Director of Siriraj Institute of Clinical Research

Winai Ratanasuwan is Associate Professor specialized in infectious diseases and immunodeficiency.

Education:

  • Doctor of Medicine (M.D.), Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. (1986)
  • Graduate Diploma in Clinical Medical Sciences (Internal medicine), Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. (1990)
  • Diploma of the Thai Board of Internal Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. (1992)
  • M.P.H., University of Washington, USA. (1995)
  • Fellowship Infectious Diseases, Creighton University School of Medicine, Omaha, Nebraska, USA. (1998)
  • Diploma of the Thai Board of Preventive Medicine (Clinical Preventive Medicine), Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. (2001)
  • Diploma of the Thai Board of Family Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. (2002)
  • Diploma of the Thai Subspecialty Board of Infectious Diseases, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. (2004)

Prof. Kulkanya Chokephaibulkit, MD

Consultant & Founding Director

Kulkanya Chokephaibulkit is Professor of Pediatric Infectious Diseases and Founding Director of the Siriraj Institute of Clinical Research.

Assoc. Prof. Somruedee Chatsiricharoenkul, MD

Vice Director, Shared Services

Somruedee Chatsiricharoenkul is Associate Professor of Pharmacology and Vice Director of the Siriraj Institute of Clinical Research.

Assoc. Prof. Dr.Pongsakorn Tantilipikorn, MD, PhD, FRCOT

Vice Director, Site Management Organization

Pongsakorn Tantilipikorn is Associate Professor in Rhinology & Allergy, and Chair of the Center of Research Excellence in Allergy & Immunology.

Assist. Prof. Dr. Suvimol Niyomnaitham, MD, MSCE, PhD

Vice Director, Clinical Research Support

Suvimol Niyomnaitham is Assistant Professor of Pharmacology and Vice Director of the Siriraj Institute of Clinical Research.

SICRES Management

Assoc. Prof. Winai Ratanasuwan

Director of Siriraj Institute of Clinical Research

Winai Ratanasuwan is Associate Professor specialized in infectious diseases and immunodeficiency.

Education:

  1. Doctor of Medicine (M.D.), Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. (1986)
  2. Graduate Diploma in Clinical Medical Sciences (Internal medicine), Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. (1990)
  3. Diploma of the Thai Board of Internal Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. (1992)
  4. M.P.H., University of Washington, USA. (1995)
  5. Fellowship Infectious Diseases, Creighton University School of Medicine, Omaha, Nebraska, USA. (1998)
  6. Diploma of the Thai Board of Preventive Medicine (Clinical Preventive Medicine), Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. (2001)
  7. Diploma of the Thai Board of Family Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. (2002)
  8. Diploma of the Thai Subspecialty Board of Infectious Diseases, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. (2004)

Prof. Kulkanya Chokephaibulkit , MD

Consultant & Founding Director

Kulkanya Chokephaibulkit is Professor of Pediatric Infectious Diseases and Founding Director of the Siriraj Institute of Clinical Research.

Assoc. Prof. Somruedee Chatsiricharoenkul, MD

Vice Director, Shared Services

Somruedee Chatsiricharoenkul is Associate Professor of Pharmacology and Vice Director of the Siriraj Institute of Clinical Research.

Assoc. Prof. Dr.Pongsakorn Tantilipikorn, MD, PhD, FRCOT

Vice Director, Site Management Organization

Pongsakorn Tantilipikorn is Associate Professor in Rhinology & Allergy, and Chair of the Center of Research Excellence in Allergy & Immunology, Faculty of Medicine Siriraj Hospital.

Assist. Prof. Dr. Suvimol Niyomnaitham, MD, MSCE, PhD

Vice Director, Clinical Research Support

Suvimol Niyomnaitham is Assistant Professor of Pharmacology and Vice Director of the Siriraj Institute of Clinical Research.

What we do

SICRES conducts cost-effective clinical research at international standards and offers full-service clinical trial design and management. We offer a suite of capacities and services, including

  • Experienced investigators and highly-trained clinical research staffs
  • Precision clinical trial design and management (Phase I to IV)
  • Bioequivalence studies, Feasibility surveys, Safety and Efficacy evaluations
  • Integrated database development and biostatistical analysis
  • Training and development of research staffs
  • High impact medical publications and presentations
  • Patient safety and adverse event monitoring
  • A national and international research network
  • 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-2

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.

Contract Management

Assist the sponsors/CROs by facilitating Clinical Trial Agreement (CTA) process.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Data Management

Provide highly professional, rapid, and exacting clinical data management services.

Our experienced staff assure the reliability of study’s data.

Medical Writing

Provide medical writing support for every stage in product development, from protocols, informed consent forms (ICF) to clinical study reports (CSR).

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.

Manuscript editing service

Polish a manuscript draft until it is ready to submit. Consultation service for writing medical articles is also provided.

Feasibility-2

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.

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.

Feasibility-2

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.

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.

Therapeutic Areas

Applied Thai Traditional Medicine

Dermatology

Allergy and Clinical Immunology

Cardiovascular

Endocrinology and Metabolism

Gastroenterology

Hematology

Infectious disease and tropical medicine

Oncology

Nephrology & Urology

Neurology

Respiratory Disease and Tuberculosis

Rheumatology

Obstetrics & Gynaecology

Ophthalmology

Orthopedics

Otorhinolaryngology

Pediatrics

Psychiatry

Vaccines

Organization Chart