Prodia the CRO earns Frost & Sullivan’s 2022 Indonesia Company of the Year Award in the contract research organization industry. (Check out the video)
FROST & SULLIVAN 2021
In 2021, Frost & Sullivan recognizes Prodia’s commitment towards building a one-stop destination for all CRO client needs within and beyond Indonesia. Frost & Sullivan commends Prodia for successfully identifying industry challenges and directly tackling them. With its strong overall performance, PT. Prodia Diacro earns Frost & Sullivan’s 2021 Indonesia Customer Value Leadership Award in the contract research organization industry. (readmore)
FROST & SULLIVAN 2020
Frost & Sullivan announced PT. Prodia Diacro Laboratories as the recipient of the 2020 Indonesia CRO Customer Value Leadership Award. The Frost & Sullivan Best Practices awards have identified and honored best-in-class companies that have demonstrated excellence in their respective industries. Award recipients were identified based on indepth interviews, analysis, and extensive secondary research conducted by Frost & Sullivan’s analysts.
Watch the Video of the 2020 Frost & Sullivan Asia-Pacific Best Practices Virtual Awards Ceremony.
Top 10 Clinical Trial Management Consulting/Service Companies in APAC – 2020
Clinical research and trials are an important part of pharmaceutical R&D. They not only ensure quicker ROI made for the pharma firm but also drive better and safer access to patient care.
Every clinical research and trial initiative is held on achieving two core believes-reach new market segments and introduce new drugs. Numerous pharma firms are taking steps toward incorporating the latest techniques to attain these targets. One of the ways to realize such activity is by outsourcing clinical research practice. A trend resulting from high drug costs-outsourcing of clinical research-is reshaping the drug development services industry. Today, enterprises in pharma clinical research offer services ranging from preclinical evaluations, study design, and clinical trial planning and management to independent safety data monitoring and bio-statistical analysis. Even adopting electronic records has seen a surge in the last few years. Clinical research service providers are going paperless to ensure that their operations around drug applications such as researching, analysis, and data management are manual-free, error-free, swift, easy, and automatic. These electronic records have also found support from the latest technologies that capture the clinical trial management systems for administrative information.
The integration of silos of pharma and clinical research- related information flowing through numerous networks from one medical firm to another is yet another challenge that needs to be eliminated through clinical development and commercialization. In the near future, the upcoming trend is likely to relate to integrating the data collection, data management, data repository, and safety data under one centralized platform.
In this edition, Pharma Tech Outlook has compiled a list of Top 10 Clinical Trial Management Consulting/Service Companies in APAC 2020 that are offering services that improve the clinical research and trial for every pharma firm. Simultaneously, Pharma Tech Outlook also explores the untapped opportunities that might otherwise go unseen by many service providers and pharma firms in the clinical research and trial space.
We present to you Pharma Tech Outlook’s “Top 10 Clinical Trial Management Consulting/Service Companies in APAC – 2020”
Prodia the CRO Revolutionizing the Clinical Studies
Prodia the CRO was established in 2007 as a fullservice CRO with the focus on delivering good clinical practices (GCP-based) trial support to healthcare firms in Indonesia. Headquartered in Jakarta, Prodia brings togetherthe ethically-diverse Indonesian manuscript writing, study conduct, and training on protocol development to its customers and partners. Through the collaborations with Prodia the CRO, many internationally acclaimed CROs receive unparalleled service that includes conducting a feasibility study for their potential population with the nation’s fast growing medical infrastructure projects and consultation on medical devices. “We act as a and lower trial costs to develop an integrated service suite. The company’s solution portfolio includes site management, study document development, clinical trial consulting, clinical trial submission, clinical study monitoring, medical writing, and quality assurance and audit. “Our ultimate mission is to provide GCP trials with competitive cost, timeline-bound delivery, and compliance with ICH-GCP guidelines to biopharmaceutical and biotechnology companies and other global CROs,” states Erizal Sugiono, Director of Prodia the CRO. “Our accumulative and vast experiences in providing clinical trial services to local as well as multinational companies with a commitment to reach quality through qualified and dedicated resources helps us stay ahead of the curve in the Indonesian market.”
One of the major challenges in clinical trial development and study is around locating, selecting, and assessing a site/location that can adequately support healthcare organizations in conducting unbiased clinical trials. Many leading biopharmaceutical companies and global CROs are repetitively demanding for a reliable partner that could assist them through the site monitoring process, either on-site or remotely. Prodia addresses this issue by performing site capacity building to find a location that supports clinical research units (CRU) and is equipped with good systems, resources, and infrastructure. To discover such a site for its clients, Prodia the CRO has formulated a site management organization (SMO) division that empowers sponsors and investigators to administer the CRUs with various services—feasibility study,
provision of site staff, training, and subject recruitment. “Our SMO is developed to collaborate with other CROs and medical organizations to increase the number of qualified clinical trial sites all across Indonesia,” mentions Erizal. The company also places significant focus on imparting GCP training along with manuscript writing, study conduct, and training on protocol development to its customers and partners. Through the collaborations with Prodia the CRO, many internationally acclaimed CROs receive unparalleled service that includes conducting a feasibility study for their potential projects and consultation on medical devices. “We act as a rescue CRO for some local studies in Indonesia. Once a medical organization has established a potential study in Indonesia, their preference of local CRO to work with is Prodia, without a second thought,” exclaims Rosalia.
Prodia the CRO also has a sister company, Prodia Laboratory that provides a highly-advanced and equipped laboratory space for clinical trial testing. Currently, Prodia Laboratory expanded its capability to offer Next Generation Sequencing (NGS) testing and genomic testing for early detection of cancer risk, nutrigenomics tests, and metabolomic tests. Besides, to fulfill the clients’ demands around biological product clinical trial, Prodia Laboratory serves the anti-drug antibodies (ADA) testing.
The future holds immense possibilities for Prodia the CRO. The company has mapped out a dynamic growth plan that includes expanding its business scope to incorporate clinical safety and efficacy testing of cosmetic products. The testing will play a key role in substantiating product claims whilst also ensuring that the products are safe and effective for consumer use. “Our cosmetics clinical testing service is designed to support the client from study design and planning to reporting stage. Overcoming challenges in carrying out clinical trials, such as volunteer recruitment and ensuring that clinical data is robust, is essential for success,” mentions Erizal. To further achieve its objective in clinical trial management, Prodia the CRO is pursuing the advance technology for laboratory testing along with Prodia Laboratory and planning on extending to provide e-CTMS/ CRF. “Our mission is to lead the Indonesian clinical trials management market and with such a plan of action, we are on the track to achieve that goal,” concludes Erizal.
IASMED Virtual Course and Workshop on Good Clinical Practice 20 – 21 September 2024
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
“Happy Independence Day, Indonesia!”
Today, 17th of August, we pay tribute to the legacy of our forebears who fought for the freedom we cherish. Indonesia’s march towards independence stands as a testament to the fortitude and resilience of its citizens. As we commemorate our 79th Independence Day, let us reflect on the sacrifices of our heroes and the enduring spirit of our people.
This day serves as a reminder of the power in our unity and the splendour in our diversity. Our national motto, “Bhinneka Tunggal Ika” – Unity in Diversity, embodies the vigour and richness of our multicultural legacy. This ethos of solidarity and tenacity also inspires Prodia the CRO, as we join hands to improve our capacity and capability for clinical trials in Indonesia. Let us strive to shape an Indonesia that fills us with pride, a place where every individual has the opportunity to realize their aspirations.
“May our country flourish and continue to make its mark on the world stage. Wishing everyone a joyous Independence Day and may the essence of Merdeka perpetually guide us. Let the flame of liberty illuminate our journey!” Prodia the CRO.
Happy Independence Day, Indonesia! Merdeka!
Prodia the CRO attend the 5th ARSPTN Annual Meeting
[Bandung, Indonesia] On 20 July 2024, Prodia the CRO attended the 5th 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 5th 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 5th 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.
Prodia CRO will attend DIA 2024 Global Annual Meeting
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:
- Indonesia Clinical Research Center (INA-CRC)
- 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>
