Prodia the CRO awarded as 2023 Indonesia CRO Company of the Year

As a leading CRO company in Indonesia, Prodia the CRO keeps on taking steps forward and strives to be in our best potential. Being the award-winner of this category for 2 years in a row increases our confidence as well as our eagerness to improve our services, to adapt more and dive deeper into this industry and give better support to our customers and partners.

Referring to Frost & Sullivan’s report, Asia-Pacific’s (APAC) contract research organization (CRO) space has matured since the COVID-19 pandemic. The region’s significance in the industry is due to a notable increase in clinical research activities, particularly during the pandemic. Thanks to evolving trial dynamics, countries like Indonesia increasingly draw drug sponsors and CROs with well-developed infrastructure and diverse demographics. Prodia the CRO with our expertise and established networking across the country, and through our local-wise understanding about the clinical trial environment, always try to ensure that the desired goal of the clinical trials which is to obtain the best research outcome in the most effective way, efficient cost and timeline, without neglecting the rights of the patients and ethical aspects of the procedures, could be reached by great trial management throughout project preparation and conduct.

This recognition is the result of many individuals: hard work of our employees, and ultimately, the trust of our customers, partners, and investors who make critical decisions every day to support Prodia the CRO and contribute to our future. Thank you for believing in Prodia the CRO. <BAN>

Clinical Research Unit (CRU) Webinar and Workshops

[Jakarta, Indonesia] — The Ministry of Health of the Republic of Indonesia issued a Ministry of Health Decree Number HK.01.07/MENKES/1458/2023 about Clinical Research Conduct in Hospital. In order to respond to the technological development in medicine and the increase of health problems complexity, the hospitals need to perform clinical research and innovation to improve health services in the hospital. To carry out the clinical research in hospital, it is necessary to conduct:

  1. Indonesia Clinical Research Center (INA-CRC)
  2. Clinical Research Unit (CRU)

As stipulated in this decree, the Clinical Research Unit (CRU) should be established in government-owned hospital, regional government hospital and private hospital. The CRU will be responsible for managing clinical research performed in the hospital.

In collaboration with the Directorate of Health Services Governance, Ministry of Health of The Republic of Indonesia, The Indonesia Association for The Study of Medicinals (IASMED) organized a Clinical Research Unit (CRU) Virtual Workshop on 21 December 2023. This workshop was attended by more than 300 participants from hospitals throughout Indonesia. It is a series of CRU webinar that has been held by IASMED since 14 November 2023.

There are two sessions and four topics presented in this workshop. The first topic discussed The Quality Management System in Hospitals, and the second session discussed the Standard Operating Procedure and Guidance of Performing Clinical Research in Hospitals. There are discussion sessions and case studies at the end of the sessions. Ms. Ida Paulina Sormin, Site Management Organization (SMO) Manager of Prodia the CRO, was given opportunity to present about the quality management system of CRU, SOP and guidance in performing clinical research in hospital. <IIR>

Hybrid GCP Training and Clinical Research Unit (CRU) Launching in RSUP Dr. M. Djamil Padang

[Padang, Indonesia] — RSUP Dr. M. Djamil Padang launches Clinical Research Unit (CRU) on Wednesday, 30 August 2023 and performing hybrid Good Clinical Practice (GCP) training on 30 – 31 August 2023. CRU Development and the GCP training were performed in collaboration with The Indonesian Association for The Study of Medicinals (IASMED) and Prodia the CRO.

As stipulated in the Decree of the Ministry of Health of the Republic of Indonesia Number HK.01.07/MENKES/1458/2023 regarding clinical research in hospitals, to perform clinical research in hospital, Clinical Research Unit should be established. The establishment of CRU is carried out to strengthen both quality and capacity in performing clinical research in hospital. Therefore, the clinical research that is performed in hospital can meet the applicable requirements and standards. RSUP M. Djamil Padang is collaborating with IASMED and the Site Management Organization (SMO) Department of Prodia the CRO for the CRU Development. These collaborations include site assessments, developing clinical research related standard operating procedures (SOP) and guidance of performing clinical research in hospital.

Along with CRU Launching, the Hybrid GCP training was also conducted by the hospital to ensure that all staff are trained and understand how to conduct Clinical Trial based on GCP standard. This course consists of 10 topics started from the Introduction of International Conference of Harmonization – Good Clinical Practices (ICH-GCP), Roles and Responsibility of Ethical Committee, Investigator Responsibilities, Sponsor & CRO Responsibilities and Preparation of Trial Site. These topics were presented by practitioners and experts in clinical trials. This GCP training was attended by 56 participants from RSUP Dr. M. Djamil Padang. During this training, all participants were enthusiastic in all sessions. In the end of the training, the participants took some test and obtained the certificate. <IIR>

 

 

Prodia The CRO: Course and Workshop on Good Clinical Practice (GCP) in Faculty of Dentistry, Trisakti University

JAKARTA – The Course and Workshop on Good Clinical Practice (GCP) was held by PT. Prodia Diacro Laboratories (Prodia the CRO), the Indonesian Association for The Study of Medicinals (IASMED) in collaboration with Faculty of Dentistry in Trisakti University on 18-19 February 2019. This course consists of 10 topics started from the introduction of the International Conference of Harmonization – Good Clinical Practice up to Sponsor/Contract Research Organization (CRO) Responsibilities. This course is held by the faculty to ensure all the dentists who work as a lecturers and faculty staffs trained and understand how to conduct a good clinical research, since many of them work in Trisakti Dental and Oral Hospital and conducting clinical research is a priority. Hence, this ensures the protection of the subjects’ safety, rights and wellbeing and the reliability of clinical trial data.

Triskati University is one of the largest private university in Indonesia that is located in Jakarta. In this course, there was 30 participants attended who are all dentists. During this event, all the participants were enthusiastically participated in all the sessions. Thus, they received both the certificate of attendance and competence.

Prodia The CRO: Course and Workshop on Good Clinical Practice (GCP) in Faculty of Medicine, Airlangga University

SURABAYA – The Course and Workshop on Good Clinical Practice (GCP) was held by PT. Prodia Diacro Laboratories (Prodia the CRO), the Indonesian Association for The Study of Medicinals (IASMED) in collaboration with Faculty of Medicine in Airlangga University on 29-30 November 2018. This course consists of 10 topics started from the introduction of the International Conference of Harmonization – Good Clinical Practice up to Sponsor/Contract Research Organization (CRO) Responsibilities. This course is held by the faculty to ensure all the clinicians who work as lecturers and faculty staffs trained and understand how to conduct a good clinical research. Hence, this ensures the protection of the subjects’ safety, rights and wellbeing and the reliability of clinical data.

Airlangga University is one of the oldest in Indonesia and a state university that is located in Surabaya. In the faculty of medicine, there are 29 departments supporting the pre-clinical and clinical studies in Medical Doctor Program. The course was attended by 47 participants. All the participants are clinicians from various science backgrounds such as pharmacology, neurology, physiology, etc. During this event, all the participants were enthusiastically participated in all the sessions. At the end, they received both the certificate of attendance and competence.

Prodia The CRO: Course and Workshop on Good Clinical Practice (GCP) in RSUP Dr. Hasan Sadikin 2018

BANDUNG – The Course and Workshop on Good Clinical Practice (GCP) was held by PT. Prodia Diacro Laboratories (Prodia the CRO), the Indonesian Association for The Study of Medicinals (IASMED) in collaboration with RSUP Dr. Hasan Sadikin on 12-13 November 2018. This course consists of 10 topics started from the introduction of the International Conference of Harmonization – Good Clinical Practice up to Sponsor/Contract Research Organization (CRO) Responsibilities. This course is one of the regular GCP courses held by the hospital to ensure all the clinicians and other hospital staffs trained and able to conduct clinical research. Hence, this ensures the protection of the subjects’ safety, rights and wellbeing and the reliability of clinical data.

RSUP Dr. Hasan Sadikin is a government hospital located in Bandung. It is the biggest and a referral hospital to the Western Java province. This course was attended by 47 participants, which is one of the highest training participants so far. The participants are clinicians from various departments in RSUP Dr. Hasan Sadikin Bandung. They come from the group of surgery, oral surgery, urology, medical rehabilitation, physiatry, neurology, internist, cardiology, gynecology as well as skin and genital. During this event, all the participants were enthusiastically participated in all the sessions. At the end, they received both the certificate of attendance and competence.

Currently, there are over 320 hospital staffs has been GCP certified in collaboration with Prodia the CRO and IASMED at the hospital. The increase of qualified site staffs is expected to improve the running of clinical trial at the hospital supported by Clinical Research Supporting Unit (CRSU) that has been established in RSUP Dr. Hasan Sadikin.

Prodia The CRO: Course and Workshop on Good Clinical Practice (GCP) of RSUD Dr. Soetomo – 2018 Second batch

SURABAYA – The Course and Workshop on Good Clinical Practice (GCP) was held by PT. Prodia Diacro Laboratories (Prodia the CRO, The Indonesian Association for The Study of Medicinals (IASMED) and RSUD Dr. Soetomo Surabaya on 16-17 October 2018. This course consists of 10 topics started from the introduction of the International Conference of Harmonization – Good Clinical Practice up to Sponsor/Contract Research Organization (CRO) Responsibilities. This course is aimed at improving the capacity of the site staff and increasing the chance of clinical research publication amongst clinicians in Surabaya. Ultimately, it will increase the safety and wellbeing of the clinical trial participants during the study conduct, as well as increasing the reliability of clinical trial data.

RSUD Dr. Soetomo is a teaching government hospital located in Surabaya and is a referral hospital in the Eastern Java province. This course was attended by 45 participants, one of the highest participants so far. At the end of the course, all the participants received both the certificate of attendance and competence.

Currently, there are over 450 participants has been GCP certified in collaboration with Prodia the CRO and IASMED at the hospital. The increase of qualified site staffs is expected to improve the running of clinical trial at the hospital supported by Clinical Research Unit (CRU) that has been established in RSUD Dr. Soetomo.

Prodia The CRO: Course and Workshop on Good Clinical Practice (GCP) of RSUD Dr. Zainoel Abidin

BANDA ACEH – The Course and Workshop on Good Clinical Practice (GCP) was held by PT. Prodia Diacro Laboratories (Prodia the CRO, The Indonesian Association for The Study of Medicinals (IASMED) and RSUD Dr. Zainoel Abidin Banda Aceh on 08-09 May 2018. This course consists of 10 topics started from the introduction of the International Conference of Harmonization – Good Clinical Practice up to Sponsor/Contract Research Organization (CRO) Responsibilities. The aim is to ensure the protection of the subjects’ safety, rights and wellbeing and the reliability of clinical data in conducting clinical research at the site. Also, to increase the chance of publishing clinical research amongst clinicians in Banda Aceh.

RSUD Dr. Zainoel Abidin is one general hospital located in Banda Aceh, in the western of Indonesia. In this first GCP Course, there were 39 participants involved from RSUD Dr. Zainoel Abidin. Participants were varied from clinicians of different departments, pharmacists, nurses up to administrative officers who work in hospital researches. They received both the

Prodia The CRO: Course and Workshop on Good Clinical Practice (GCP) of HISFARSI in Eastern Java

BANDUNG – The Course and Workshop on Good Clinical Practice (GCP) was held by PT. Prodia Diacro Laboratories (Prodia the CRO), the Indonesian Association for The Study of Medicinals (IASMED) and HISFARSI of Eastern Java Province Chapter on 25-26 April 2018. The aim is to broaden their clinical trial knowledge and therefore the chance to become the key player in clinical trial is bigger. This course consists of 10 topics started from the introduction of the International Conference of Harmonization – Good Clinical Practice up to Sponsor/Contract Research Organization (CRO) Responsibilities. The aim is to ensure the protection of the subjects’ safety, rights and wellbeing and the reliability of clinical data in conducting clinical research at the site.

HISFARSI of the Eastern Java Province Chapter consists of pharmacist who works in the hospital in the Eastern Java Province. The fact that the majority of the participants are pharmacists has made this course special. The reason behind their involvement is so that the pharmacist might be able to participate in clinical trials more often and act as the key players. There were many pharmacists whose interested to join the course. However, this first GCP Course was limited for the first 44 participants from mainly RSUD Dr. Soetomo, Airlangga University Hospital and several hospitals in Surabaya. Of those 44 participants, there were the head of HISFARSI of the Eastern Java, Drs. Muhammad Yahya, Sp.FRS., Apt., and the head of pharmacy installation in RSUD Dr. Soetomo Surabaya, Drs. Ali Syamlan, Apt., SE, MARS, participating in the course. All the GCP participants received both the certificate of attendance and competence.

Prodia The CRO: Course and Workshop on Good Clinical Practice (GCP) in Medical Faculty of Syiah Kuala University

BANDA ACEH – The Course and Workshop on Good Clinical Practice (GCP) was held by PT. Prodia Diacro Laboratories (Prodia the CRO), the Indonesian Association for The Study of Medicinals (IASMED) and Medical Faculty of Syiah Kuala University on 15-16 April 2018. This course consists of 10 topics started from the introduction of the International Conference of Harmonization – Good Clinical Practice up to Sponsor/Contract Research Organization (CRO) Responsibilities. The aim is to ensure the protection of the subjects’ safety, rights and wellbeing and the reliability of clinical data in conducting clinical research at the site.

Syiah Kuala University is a government university located in Banda Aceh. There were many participants who interested to join the Course from both the university and Dr. Zainoel Abidin General Hospital (RSUD Dr. Zainoel Abidin). However, this GCP Course is limited for the first 40 first participants from mainly Medical Faculty of Syiah Kuala University and the rest were from RSUD Dr. Zainoel Abidin. The participants were clinicians, pharmacists, nurses and other staffs from various departments. They received both the certificate of competence and attendance.