Erizal Sugiono, Director
Prodia the CRO was established in 2007 as a full-service CRO with the focus on delivering good clinical practices (GCP-based) trial support to healthcare firms in Indonesia. Headquartered in Jakarta, Prodia brings together the ethically-diverse Indonesian population with the nation’s fast growing medical infrastructure 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.