Approval process from Ethics Committee and Regulatory somehow varies among countries and become a critical point in clinical trial. The presence of a local CRO which understands the local regulations become indispensable. Prodia the CRO supports the preparation, validation, submission and follow-up of CTA, Import License, SAE/SUSAR report, Final study report, post-inspection letter, etc.
When it comes to special global circumstances, for instance, like when the world is “in shock” due to pandemic situation which leads to unstable regulation, prolonged timelines and unexpected impacts, local CRO’s capabilities to understand the local dynamics and to establish reliable engagement with Regulatory will be indispensable to keep the clinical trial environment going, locally.
Below are the general information of Indonesia Regulatory Submission Process: