Category: News

Prodia the CRO earns Frost & Sullivan’s 2022 Indonesia Company of the Year Award in the contract research organization industry.  (Check out the video).

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 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.

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.

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.

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.

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.

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

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.

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.