Author: Superadmin CRO Prodia

Prodia The CRO team, represented by Erizal Sugiono (Director) and Rosalia Napitupulu (Business Development Manager), attended a forum group discussion initiated by Badan Pengawas Obat dan Makanan (BPOM) on October 31, 2024, held in Fairmont Hotel, Jakarta.

The topic of this discussion was “A Blueprint for Innovation Success: Optimal Quality of Clinical Trial Centers and Practitioners”. The event was held as a follow up of the Cooperation Agreement between BPOM, the Ministry of Health (MoH), and the National Research and Innovation Agency (BRIN) which was signed on July 19, 2024.

The scope of cooperation agreement includes the coordination in the clinical research approval, clinical research center mapping and guidance, clinical research registry, and improvement of clinical research practitioners competency. It is hoped that by the synergy in national policies related to research development, and utilization of science and technology, as well as clinical trial services and supervision, can be achieved.

The roles and duties of BPOM in clinical trials were described by Ria Christine Siagian, Director of Drug Registration, BPOM. The responsibilities include assessing applications for approval of clinical trial implementation (PPUK), monitoring and evaluating the conducting of clinical trials, mapping clinical trial centers, providing training in good clinical trial methods (CUKB), and disseminating PPUK data and inspection findings.

According to Indri Rooslamiati (the representative of the Directorate General of Health Services, MoH), the role of the MoH in improving the quality and safety of clinical trial implementation in Indonesia paved by the establishment of Indonesia Clinical Research Center (INA-CRC), which is a one-stop solution for the implementation of clinical research. The INA-CRC initiative includes transparency of procedures and digitalization of the Material Transfer Agreement (MTA) submission, revamping clinical study that registry through the Indonesia Clinical study Registry (INA-CRR) website, and the establishment of National Ethics Committee. The data between clinical trial approval (BPOM) will be interfaced with INA-CRC.

According to Ramatun Anggraini Kiemas (Deputy for Research and Innovation Facilitation—BRIN), BRIN is in charge of bolstering and coordinating institutions through the creation and accreditation of the Health Ethics Commission, financing the conduct of pre-clinical and clinical trials, and overseeing and carrying out clinical trials, enhancing human resource competency, and advancing clinical trial implementation.

 

Prodia the CRO, believes that this cooperation will result in a positive impact on clinical trials in Indonesia. This cooperation has the chance to increase both the number and quality of clinical studies while guaranteeing that they are carried out in a transparent, ethical, and GCP standard. Furthermore, we believe that this synergy approach will make Indonesia more appealing for clinical trials in global markets.

Prodia the CRO is a Contract Research Organization (CRO) based in Indonesia which provides GCP-based Clinical Trial supports through our integrated and wide range of services. Prodia the CRO has accumulated many experiences providing services to local as well as multinational companies with commitment to reach quality through qualified and dedicated resources. It provides customers in GCP trials with competitive costs, firm timeliness, high compliance to ICH-GCP guidelines.

The Prodia CRO team attended the launch of the Indonesia Clinical Research Center (INA-CRC) which was inaugurated by the Ministry of Health of the Republic of Indonesia at the Eijkman Building, dr. Cipto Mangunkusumo Hospital (RSCM) on October 16, 2024. The INA-CRC launch was attended by Prodia the CRO’s team, represented by Erizal Sugino (Director) and  Ida Paulina (SMO Manager).

This is a significant leap as part of the transformation of clinical research in Indonesia. In order to facilitate and coordinate Clinical Research Units (CRU) in all Indonesian hospitals, INA CRC was founded in accordance with the Decree of the Minister of Health of the Republic of Indonesia No. HK.01.07/MENKES/1458/2023 about the Implementation of Clinical Research in Hospitals.

INA-CRC will boost Indonesia as regional clinical research hub whileplaya a role in the advancement of the transformation of clinical research in Indonesia. INA CRC is dedicated to improving national competitiveness in the health sector, driving health innovation, and emerging as a major force in international clinical research. Additionally, it will make Indonesia more competitive and appealing to both domestic and foreign enterprises as a clinical research site. The Indonesian Minister of Health said that INA CRC is the missing piece of clinical trial and health innovation in Indonesia.

Furthermore, Prodia the CRO believes that clinical trials in Indonesia may be transformed and synergized with a strong commitment from every stakeholder. According to Dr. Ida Paulina, Site Management Manager of Prodia the CRO, INA CRC is a collective aspiration that has now come into reality and is anticipated to improve clinical research unit among hospitals in Indonesia. INA CRC is expected to contribute significantly to the advancement of medical innovation in Indonesia. Prodia the CRO gives its utmost commitment working with INA CRC in delivering highest quality for clinical trials through clinical research unit establishment in hospitals across Indonesia. As the first actions after its inauguration, INA-CRC launch the initiative to transform clinical trial implementation in Indonesian. Those are the re-branding Indonesian clinical registry and simplified material transfer agreement (MTA) submission. With this transformation, sponsors will have certainty in both timeline and approval process.

About Prodi the CRO. Prodia the CRO is a Contract Research Organization (CRO) based in Indonesia which provides GCP-based Clinical Trial supports through our integrated and wide range of services. Prodia the CRO has accumulated many experiences providing services to local as well as multinational companies with commitment to reach quality through qualified and dedicated resources. It provides customers in GCP trials with competitive costs, firm timeliness, high compliance to ICH-GCP guidelines.

The Indonesian Association for The Study of Medicinals (IASMED) will hold the Virtual Course & Workshop on Applied Good Clinical Practice (GCP) on 20 – 21 September 2024. This training has been recognized by TransCelerate BioPharma.

The speakers are clinical trial experts & practitioners in Indonesia that will share useful information for conducting and evaluating clinical trials. Participant will be involved in interactive workshop and case-study application for Good Clinical Practice principle in clinical trial.

To participate on this event, please register at: https://bit.ly/GCPIASMED

[Bandung, Indonesia] On 20 July 2024, Prodia the CRO attended the 5^th annual meeting of the Association of Public University Hospital / Asosiasi Rumah Sakit Perguruan Tinggi Negeri (ARSPTN) in Bandung.

The existence of public universities hospital began when the Ministry of Health issued temporary permits for seven dental and oral hospitals (RSGM) belonging to public universities (perguruan tinggi negeri) simultaneously on 27 June 2002. These seven dental and oral hospitals were belonging to University of North Sumatra, University of Indonesia, Padjadjaran University, Gadjah Mada University, Hasanuddin University, Airlangga University, and Jember University.

Meanwhile, general hospitals (RSU) that belong to the public universities began with the establishment of hospitals that belong to Gadjah Mada University and Hasanuddin University in 2010, followed by hospital that belong to Airlangga University in 2011. Other public university hospitals were established afterwards in many places according to the Ministry of Research, Technology and Higher Education (Kemenristekdikti) program at those time. In 2023, there were 39 public universities hospitals that consisted of 25 general hospitals and 14 Dental and Oral Hospitals.  The dynamics in managing public universities hospitals creating a sense of togetherness which was later manifested in the establishment of ARSPTN on 28 October 2017 in Surabaya.  To exchange ideas and experiences, ARSPTN routinely held an annual meeting. In 2024, the fifth ARSPTN annual meeting was held in Trans Luxury Hotel Bandung on 19-21 June 2024 and hosted by Padjajaran University Oral and Dental Hospitals. This meeting was attended by representatives from many public universities teaching hospital in Indonesia.  The theme of this 5^th annual meeting is “Strengthening Hospital Competitiveness in the New Era Post the Implementation of Undang-undang No. 17 tahun 2023 regarding Health”

On the fifth ARSPTN Annual Meeting, two MURI (Indonesia World Records Museum) records were broken that are MURI World Records on Playing Angklung to accompany HIV song by the largest number of health care workers and MURI Indonesia Records: interprofessional education program with the largest number of students.

Prodia the CRO was one of the Sponsors for the ARSPTN 5^th annual meeting. During this meeting, Dr. apt. Ida Paulina Sormin, M.Si, as a Site Management Organization Manager (SMO) of Prodia the CRO, gave a short presentation about the Development of Clinical Research Unit (CRU) for improving Clinical Trials in Indonesia. During the event, Prodia the CRO was also inviting the public university hospitals to collaborate with SMO for Clinical Research Unit Development.