Trainings

Site Management Organization

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Site Management Organization

Site Management Organization

All personnel involved in the clinical trial must be qualified by training. Training offered are Good Clinical Practice (GCP), Protocol Development, Manuscript writing, and Study Coordinator Training. Prodia CRO may help you in organizing and providing these trainings for all study personnel before the start of the clinical trials.

Good Clinical Practice (GCP) Training

 

Every implementation of clinical trials in Indonesia should be carried out in accordance with good clinical practice (GCP) guidelines. One of the GCP requirement for investigator and the study team is to have qualifications and competencies to perform the trial according to GCP. To support this, PT Prodia Diacro Laboratories in collaboration with The Indonesian Association for the Study of Medicinals (IASMED) provide in-house Training Course & Workshop on Applied Good Clinical Practice. In these sessions, participants will be trained by the experts in the field of clinical trials.

This will benefit the trainee in preparing, implementing, and evaluating the implementation of a clinical trial. During the workshop sessions, participants will be involved in an interactive session in stimulating the application of GCP principles in day-to-day clinical trial implementation. At the end of the course, the participants will sit to join the final test of the GCP Course to be able to obtain certificate of competency.

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Site Staff Provision

Site Management Organization

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Site Management Organization

Site Management Organization

Qualified personnel measured by education, training, and experiences is one of the key success factors in the conduct of clinical trial. Prodia Site Management Organization (SMO) may assist in the provision of qualified and committed site staff to ensure the day-to day conduct of clinical trial according to the GCP.

 

A qualified site staff should possess following qualifications: health care/medical educational background, basic clinical research knowledge, GCP-certified, well-trained, good communication skill, good interpersonal skill, assertive, flexible and knowledge on office software. To support the study needs, Prodia the SMO established the site staff provision service as follow:

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Clinical Research Unit (CRU) Development and Management

Site Management Organization

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Site Management Organization

Trial Site Capacity Building

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.

What We Offer?
  1. Ensure research/trials are conducted in accordance to protocol, GCP, and regulatory requirements.
  2. Implement systems and procedures for the monitoring and assessment of safety in clinical trials
  3. Provide centralized one-gate clinical trial activities for all departments in the hospital and
  4. Faster timeline in feasibility study, clinical trial agreement (CTA) process, ethics committee approval, and other clinical trial related activities within the hospital.
CRU that are supported by Prodia SMO:
  1. CRU RSUP Dr. Hasan Sadikin (Bandung) (2014-2019)
  2. CRU RSUD Dr. Soetomo
  3. CRU RSUP Dr. M. Djamil Padang
  4. CRU RSUD Koja
  5. CRU RSJPD Harapan Kita
  6. CRU RSUP DR. Mohammad Hoesin Palembang
  7. CRU RS UNAIR

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Subject Recruitment

Site Management Organization

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Site Management Organization

Timeliness of subject recruitment is important to the continuity of a clinical trial. Prodia the CRO supports the recruitment process by providing a well-trained and qualified recruiter also recruitment-strategy to ensure the Sponsor achieve the recruitment target.

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Investigator / Site Feasibility and Selection

Site Management Organization

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Site Management Organization

Feasibility study that conducted properly and accurately is one of the key factors to reach the most effective clinical trials. Proper feasibility studies will prevent the occurrence of unforeseen problems during the trial conduct: delay in initiating clinical trials, inadequate patient population, and other uncertainties. Prodia the CRO will help you to identify strategies to mitigate the costs and risks associated with a particular trial.

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