Quality assurance and audit are paramount in the conduct of clinical trials. Therefore, the availability of certified auditor is necessary to ensure the site comply with the protocol, GCP, SOP and other applicable regulatory requirements. Prodia the CRO provides a certified auditor to fulfill the needs of sponsor in conducting quality assurance and audit.
To quote the GCP principle of documentation: “anything not documented, never happened and does not exist”, We do understand how important documentation and archiving are. Supported by our 3rd parties, we will help to document your clinical trial essential documents properly, in accordance with the local regulation. We will provide a secure and safe facilities for your valuable papers, which includes regular fumigation/pest control to prevent them from becoming weathered.
Data are important, but data-tailoring are even more. Prodia the CRO, in collaboration with external biometric experts and consultants with profound track records in data management, will accompany you through the data collection phase, help you to take in-depth journey to your gathered data, process them and bring you towards your desired goal.
We provide full services of statistical and study design, statistical methodology and analysis planning, randomization package, query management, interim analysis, generation of high quality study data tabulation model, etc.
One of the key factors for the success in clinical study is by having a godd clinical study monitoring plan and performance, which will oversee the overall progress. It is one of the significant step to ensure a clinical trial project is going through the “right corridor” and that it is conducted, recorded and reported in accordance with the applicable requirements.
Our great eyes on protocol adherence and GCP compliance will help to obtain as reliable data as possible. Through our knowledge in many scientific area and extensive experience about local challenges, we will identify the potential obstacles at soonest and help you to find the most suitable ways to prevent it from occurring. Our reliability in managing clinical trials will contribute in driving the project to the targets.
Clinical monitoring is one of our stand-alone services. Your project will be taken care by GCP-certified CRAs with specialized skills, knowledge, ability and experience
The availability and continuity of IP are the important things to be assured during a conduct of clinical trial. Prodia the CRO provides the IP management service which include managing and assuring the IP stock, storage and delivery of the IP to the clinical trial site, as well as IP leftovers destruction. We will also support you prepare documents for obtaining IP import license from Regulatory.
Prodia CRO offers extensive medical writing services for your study such as: study synopsis, protocols and amendments, clinical study reports, abstract, and/or manuscript publications. We work closely with our external Consultants who are all competent medical writers with appreciable expertise in this field, great exposure to global standards and could promptly adapt to your needs.
Manuscript is believed to be the final stage of clinical trial project, however, rather than an ending it is more like a door to the future. It depends on the medical writer, whether or not the trial report will be impactful.
Writing your documents with us will certainly be structured according to procedures and comply with the ICH-GCP guidelines. Through our story-telling-like writing, we will help readers to understand all trial outcomes, either the beneficial result or the harmful ones, as this will impact the future research. We do understand that well-reported trials are key for the evolution of our healthcare system.
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:
It is necessary to capture and document all aspects of clinical trial before, during, and after trial completion, to ensure the rights, safety and wellbeing of the trial subjects are protected and the reliability of data are maintained. Prodia the CRO supports the clinical trial study document development to meets the trial purposes, assisting client to generate scientific, reliable, and traceable study documents.
Through our year-long experience in preparing submission documents and our wide coverage of therapeutic area, as well as our established networking with local KOLs, we will provide you with fresh insights that you might not find elsewhere. Supported by experienced personnel, Prodia the CRO will help providing study documents which meet the principle of ICH-GCP guidelines and the local regulations. This service is customized based on the clients’ clinical trial specific needs.
Our capabilities of study document development is including but not limited to:
