Prodia the CRO
Changing the Face of Clinical Studies

A large, ethnically diverse, treatment-naïve population coupled with benefits that include advanced and efficient hospital infrastructure, lower trial costs, and support from the government, makes Indonesia a promising location to conduct clinical trials. Headquartered in Indonesia’s capital Jakarta is Prodia the CRO, a contract research organization (CRO) that aims to help its clients— biopharmaceutical and biotechnology companies, and other global CROs—bring new, better medicinal products to a market that continually demands generic medicines. Erizal Sugiono, director of the decade-old firm, says, “Our vision is to become the leading CRO and the most reliable partner in providing drug development services.” The company achieves this by providing good clinical practice (GCP) based clinical trial support through its integrated suite of services spanning site management, study document development, clinical trial consulting, clinical trial submission, clinical study monitoring, medical writing, and quality assurance and audit.

Founded in 2008, Prodia is the only CRO in Indonesia that commits to performing site capacity building, which involves finding a suitable site that can support clinical research units (CRU) with good systems, resources, and infrastructure—all of which are vital for a clinical study. “Getting successful result of any clinical trial starts with choosing the right site and managing it efficiently. This is where Prodia’s site management organization (SMO) division proves its mettle,” adds Sugiono. The SMO division aids sponsors and principal investigators in managing the site with services that include feasibility study, development and management of CRUs, provision of site staff, training, and subject recruitment. The SMO also supports these sites to have good compliance with ICH-GCP protocols and other regulations.

CROs that choose Prodia as their partner to conduct clinical trials gain advantages that encompass access to an established network of nation-wide hospitals and clinicians, provision of dedicated and highly qualified site staff that aid in carrying out effective and efficient study conduct, expert trainers in clinical trial training, and commitment to confidentiality and quality.

In addition to site capacity building, Prodia offers manual and eClinical trial management. Furthermore, in collaboration with Indonesia Association of Study Medicinals (IASMED), the company also provides GCP training as well as training on protocol development, manuscript writing, and study coordination.

Prodia also has a sister company called Prodia Laboratory, in collaboration with which it offers laboratory test services for clinical trials. The services include routine tests such as hematology and coagulation, chemistry, immune-serology, microbiology, biomolecular (including next generation sequencing and metabolomic), and other specialized on-demand laboratory tests. “Today, Prodia laboratory is the only laboratory in Indonesia with CAP certification to provide research purpose testing by the esoteric lab,” asserts Sugiono.

For over the last ten years now, through its wide range of integrated services, Prodia has helped numerous clients mitigate site activation, study preparation, approval submission, and other related challenges. “We are committed to providing the best services to our clients, no matter the situation and circumstance. That is one of the reasons why we have several repetitive clients that continue to partner with us,” explains Sugiono. Substantiating this aspect of the company is a testimony from a client in Japan: “Although we conducted the trial at a facility that lacked the necessary resources and requirements, Prodia’s clinical research associates helped us seamlessly manage the entire study. We appreciate it so much.”

Moving forward, the company will continue to provide its customers in GCP trials with competitive cost, firm timelines, and high compliance to ICH-GCP guidelines. “We are currently working on the implementation of e-CRF, an electronic case report for clinical studies,” mentions Sugiono. With deep-seated industry experience and global expertise, offering services at a competitive price, Prodia has certainly achieved its objective of being the leading reliable partner to conduct clinical studies in Indonesia.