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.
