Gaps in Running a Clinical Trials
Clinical Trial is a complicated process to undertake. Sponsor or Principal Investigator might face the following challanges:
1. Low compliance to protocol, ICH-GCP, and other regulations.
2. Limited time allocation of the investigators. Most Principal Investigator are Key Opinion Leader in their fields. Hence, they are often extremely busy persons and therfore need support from a commited and qualified study staff to support the clinical trial.
3. Difficulties in finding competent and commited staffs resulting in delay of recruitment and increase of clinical trial budget.
4. Tortuous and time-consuming clinical trial process at the site.
5. Limited knowledge on clinical trial, procedure and facilities at site resulting in long overdue paperwork, longer clinical trial application process and ineffective clinical trial conduct.
To overcome these challanges, in collaboration with hospital / medical faculty we establish centralized one-gate CRU through:
Developing One-Gate Clinical Research Unit (CRU)
Building research capacity at the site is key for improving health system and developing new medicines. Collaboration among research key players, especially investigators and personnel at sites, is essential for its success. To support this idea, a good system within the site need to be set to trigger effective trial activities and compliance to the protocol, GCP guidelines and other applicable regulation.
Clinical Research Unit (CRU) is a collaborative action initated by Prodia SMO, however CRU owned and managed by the hospital. The aim is to provide a strong site capacity to develop a highly quality site. This will trigger a growing number of clinical trial conducted in Indonesia. Ultimately, it will raise the number of quality researchers, publications, as well as producing more experienced qualified investigators.