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The Synergy of the BPOM, Ministry of Health, and BRIN to Create a Clinical Trial Ecosystem in Indonesia
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 Launching of Indonesia Clinical Research Center (INA-CRC)
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.
Methadone Withdrawal Schedule: Timelines & More Delphi
Read on to learn more about the complexities of methadone addiction, the challenges of withdrawal, and the vital importance of seeking professional help to navigate this treacherous path to recovery. Withdrawal is extremely uncomfortable, and the risk of returning to other opiates is high. For this reason, some people discuss staying on methadone treatment at lower doses if they can. Once a person is stable at a lower dose, the doctor will attempt to taper you from the drug again. Each person will experience withdrawal differently, based on the amount they were taking and other factors. For that reason, you must speak with your doctor about what to expect.
Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take methadone while breastfeeding. Methadone is available as many different products that are taken in different ways.
Recovery Support
You and your care team will work together to determine how long you will need to take this medication. If your care team wants you to stop this medication, the dose will be slowly lowered over time to reduce the risk of side effects. Taking this medication with other substances that cause drowsiness, such as alcohol, benzodiazepines, or other opioids can cause serious side effects. Call emergency services if you have problems breathing or staying awake. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs.
Establish an appropriate drug testing program with policies to prevent falsification of specimens and to respond to tests that are negative for methadone. May have lower levels of opioid tolerance based on their recent history. Assess recent opioid use, including frequency, quantity, type, route, and recency (last day of use and use in the past 30 days). Caution patients that methadone may affect cognition and psychomotor performance and can have sedating effects. Urge patients to be cautious in using heavy machinery and driving until they are sure that their abilities are not compromised.
Warnings for people with certain health conditions
- Abrupt cessation of this long-acting opioid can lead to severe methadone withdrawal symptoms, significantly increasing the risk of relapse due to the discomfort these symptoms cause.
- If withdrawal symptoms lessen, the patient should return the next day to be reassessed and to continue the dose induction process.
- It is important for people to be aware of the possible risks of opioid use during pregnancy, as well as treatment options including medications for opioid use disorder.
- Your doctor may change your dose of methadone during your treatment.
- If you take methadone for opioid use disorder, you will get your medicine from your treatment program.
If you experience pain during your treatment, your doctor may increase your dose or may prescribe an additional medication to control your pain. Talk to your doctor about how you are feeling during your treatment with methadone. If you feel that your pain is not controlled or if your pain increases, becomes worse, or if you have new pain or an increased sensitivity to pain while you are taking methadone, call your doctor. Do not take extra doses of methadone or take doses of methadone earlier than they are scheduled even if you experience pain. If you have what helps with methadone withdrawal an addiction to another opioid, your doctor may give you methadone to prevent you from having severe withdrawal symptoms.
- Outpatient treatment is also an option for those whose methadone addictions have been diagnosed as minor by a substance abuse professional.
- Peak withdrawal occurs within three to eight days after last use.
- Medical clinics dispensing methadone should maintain clear records of the amount of methadone dispensed each day, and the amount of methadone stored on the premises.
- If you continue to experience pain after you finish taking methadone, call your doctor.
- Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Questions about treatment?
Outpatient treatment is also generally recommended for those who have completed an inpatient program but are still new to sobriety. Most medical detoxes provide a tapering off of the drug, or reducing the user’s dosage over a period of weeks. This method reduces the severity of withdrawal symptoms and is usually recommended over quitting “cold turkey.” However, tapering off the drug takes longer. Due to the risk of methadone misuse and overdose, methadone therapy is only available to people who are enrolled in a government-approved treatment program. A doctor monitors your methadone intake and response to make sure that the withdrawal process is safe and effective.
Weeks 3-4 — Post-Acute Withdrawal Symptoms (PAWS)
A person should make sure that they are under medical supervision throughout the entire process. After methadone withdrawal https://prolificvent.com/the-role-of-detox-centres-in-addiction-treatment/ symptoms peak between days three and eight, it can take around 10 days for withdrawal symptoms to subside. In some cases, it may take longer for withdrawal to resolve completely. Symptoms of withdrawal from methadone are similar to those of other opiates, such as heroin and morphine.
Duration Of Withdrawal
Prisoners in New South Wales, Australia, can access methadone and buprenorphine maintenance treatment. Continuity of maintenance treatment between prison and community settings is critical to reducing the risk of relapse to drug use and criminal re-offending. It is recommended that all patients receiving MMT in closed settings be assisted to transfer to a community-based MMT program to continue treatment.
Certain symptoms during methadone withdrawal require immediate medical evaluation. Recognizing these warning signs could prevent serious complications or save your life. Medication-assisted treatment continues playing a crucial role even after methadone withdrawal. Many individuals transition to other MAT options like buprenorphine or naltrexone to maintain long-term recovery stability. Opioid use disorder is a complex, treatable chronic medical condition from which people can recover. Other medications may interact with methadone and cause heart conditions.
Treatment with methadone or buprenorphine is recommended for pregnant women with opioid use disorder. Buprenorphine treatment may lead to better health outcomes for infants than methadone treatment. Certified treatment programs are obligated to prescribe and dispense methadone in accordance with the treatment requirements outlined in the Federal Opioid Treatment Standards (42 CFR 8.12). Addiction to opioids, such as heroin and prescription opioids, is the leading cause of drug overdose in the United States. For those with addiction, untreated physical and psychological withdrawal symptoms may be severe, making it challenging to abstain from using the drug.
It’s possible for some people to become addicted to methadone as they use it to wean themselves off of another prescription painkiller. A distressing withdrawal from methadone is likely to lead to relapse. Patients tend to be successful when the taper is slow and they are surrounded by support.
Typically administered as a “maintenance dose,” methadone can suppress withdrawal symptoms for 24 to 36 hours. While it plays a vital role in saving lives by preventing overdose deaths, one significant downside is its Sobriety potential to cause extended withdrawal symptoms when discontinued. Doses should be decreased for reports of symptoms of opioid intoxication or oversedation.
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.
FROST & SULLIVAN 2022
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.
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