Our experts can help you manage and expedite your clinical trials in Asia to get your products to market sooner.
When registering new medical products in Asia, there are various reasons Western companies may want or need to conduct local clinical trials. The most common reason is that the local Asian government may require the clinical data for product registration. In addition, the large, genetically diverse population in Asia creates ideal sample populations, and the cost to perform clinical studies in Asia may be lower than in Western countries. In some cases, post market data may be required.
An understanding of the regulatory requirements in each Asian country and experience in dealing with the local regulatory authorities is essential in administering a smooth, successful clinical trial in Asia. Pacific Bridge Medical (PBM) can act as your contract research organization (CRO) or help you identify a qualified Asian CRO. Our on-the-ground teams in Asia are highly experienced with the related regulatory affairs and can locally manage the full clinical trial process to ensure that it is conducted effectively and successfully.
We offer the following services for medical device, pharmaceutical, and biotechnology companies looking to conduct clinical trials in Asia:
- Clinical Trial Consulting Services
PBM will provide clinical trial consulting services, including consultations with all local Asian governments. We can help you develop an effective Clinical Investigation Plan with clinical trial strategy, clinical trial study design, and clinical trial protocol.
- Regulatory Support
We can assist with clinical trial applications (CTA) and clinical trial notifications (CTN) as required for clinical trial initiation in each Asian country. Our on-the-ground teams consist of experienced professionals who will meet with the appropriate Asian regulatory agencies on your behalf throughout the clinical study. We will provide guidance on meeting the Institutional Review Board (IRB) and Independent Ethics Committee (IEC) requirements.
- Clinical Trials Management
We can comprehensively manage the clinical trials process by conducting the trials and completing the clinical trial reports. Our experts will evaluate clinical trial and non-clinical trial data; conduct gap analyses; and determine safety and efficacy, along with primary and secondary endpoints, as required for your specific product.
- Quality Compliance and Audits
We can conduct on-site audits of your clinical trials and consult on the guidelines for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practices (GVP), Good Quality Practice (GQP), Good Manufacturing Practice (GMP), etc.
- Adverse Events and Post Market Surveillance
We will report adverse events and implement suggestions on additional tests and required data. We can assist in post-approval and post-clearance clinical trials to maintain the safety, efficacy, and performance of the product through its life cycle.
Clinical trials that are conducted properly will facilitate a smooth registration approval process and expedite access to the Asian markets. If you need assistance with clinical trials for your medical product in Asia, contact us now for a consultation with our Asia regulatory experts, or select your target market below for more information regarding clinical trials in each Asian country.
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