A success on clinical trial conduct requires a good site management system. By doing so, the site team might be able to perform clinical trial activities effectively and efficiently whilst ensure the compliance to protocol, Good Clinical Practice guideline and other applicable regulations. At the end, it ensures the protections of human subjects that involved in clinical trial and data reliability.
Site Management Organization (SMO) division in Prodia that has been initiated since 2014 aimed to improve the clinical trial awareness and strengthen the capacity of the trial sites in Indonesia.
Constraints established at the clinical trial sites
Clinical trial is a complicated process to undertake. It involves a good infrastructure at the site, systems, multiple partners and a consistence teamwork, empowerment, transparency as well as communication. Therefore, either the sponsor or principal investigator might face the following challenges:
- Lack of interest or awareness for research amongst clinicians, medical practitioners or site staffs;
- Difficulties in finding competent and committed staffs;
- Tortuous and time-consuming clinical trial process at the site;
- Time allocation of the investigators. Most PIs are Key Opinion Leader in their field. Involvement in clinical research might not be their first priority;
- Lack of experience in clinical trials leading to lack of empowerment, communication and transparency during clinical trial conduct.
What SMO offers?
SMO division work to establish centralized one-gate Clinical Research Unit (CRU) through:
Set up of infrastructure at the site;
Infrastructure is on a high demand when it comes to clinical research. A good infrastructure may easier and faster the conduct of clinical trials and ultimately protects subject’s rights, safety and wellbeing over the time. Support from the site (hospital, clinic, community) are necessary in the establishment of infrastructure for clinical research at the site. Prodia SMO supports the site by supervising the establishment of research infrastructure in correspondence to Joint Committee International (JCI) and KARS (Hospital Accreditation Committee) requirements.
Set up of system, manuals and guidelines to conduct clinical trial;
The establishment of a good system and manuals at the sites are paramount in the technical preparation of clinical trial conduct. These will reduce the bureaucracy and paperwork and in contrary ease the learning process of research staffs. In addition to that, guideline on good clinical practice is playing a key role in protecting subject’s rights, safety and wellbeing, as well as the reliability of clinical trial data. Prodia SMO supports in the establishment of system, manuals and guidelines at the sites.
Provision of competent and committed staffs; and
Good clinical practice (GCP) guideline requires qualified personnel to join the clinical trials. Personnel qualifications are measured based on education, trainings and experiences. To ensure this, Prodia SMO provides GCP training service that might help increase the qualification of site personnel in conducting clinical research. This GCP training is conducted in collaboration with The Indonesian Association for The Study of Medicinals (IASMED).
Empowerment, communication, transparency and teamwork.
Consistence supervision by the Principal Investigator (PI) to study personnel is critical. A good leadership within the site team is vital to ensure the site personnel are empowered, communicative, transparent and make a good teamwork. Prodia SMO provides supervision to collaborated sites to improve the quality of the clinical trials, especially during the clinical trial conduct.
Currently, there are two CRUs that have been actively operating:
CRU of Dr. Hasan Sadikin General Hospital (RSUP Hasan Sadikin)
CRU of Dr. Soetomo General Hospital (RSUP Soetomo)
The CRU works to facilitate all the studies at all stages that are running at the site. Overall, SMO established the CRU to:
- Ensure the research/trials are conducted in accordance to protocol, GCP and local regulatory requirements;
- Implement systems and procedures for the monitoring and assessment of safety in clinical trials;
- Provide centralized one-gate clinical trial activities for all departments in the hospital; and
- Faster timeline in feasibility study, clinical trial agreement (CTA) process, ethics committee approval, and other clinical trial related activities within the hospital.