Local expertise is the key to ensuring a seamless regulatory submission process for your clinical trial. Leveraging our local expertise, VIETSTAR’s regulatory team can proactively guide you through potential challenges. Our clinical trial compliance experts will closely monitor the risks associated with each submission in order to optimize your research timelines and ensure the success of your study.
Once the clinical trial has begun, you can rely on this same team of professionals to take care of all ongoing interactions with the regulatory agency. Count on VIETSTAR to handle all details of the clinical research compliance process, including:
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Amendments
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Serious Adverse Event (SAE) reporting
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SUSARs
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Annual reports
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Study close-out reports
VIETSTAR BIOMEDICAL RESEARCH: THE REGULATORY SUBMISSION EXPERTS
There is a reason that VietStar Biomedical Researchis often contracted by larger CROs to handle their regulatory submissions. Our team of compliance experts understands local regulations and stays up-to-date on legal changes that have the potential to affect the management of your study. VIETSTAR’s knowledge and established relationships allow us to effectively navigate the unique challenges of international clinical trial regulations.
At VIETSTAR BIOMEDICAL RESEARCH, we’ve evaluated our regulatory management processes to ensure that we can generally beat the approval times of other contract research organizations, providing a faster initial submission and review process for our clients. Please contact VietStar Biomedical Research today to learn about our regulatory submission and management services.
Clinical trial registration/licensing
Our experience encompasses obtaining clinical trial approvals from IRBs at different levels and from Vietnam Health Authority. We can also provide assistance with drug and medical equipment, medical device importation, biomedical specimen exportation, unused drug destruction, importation of biological substances for External Quality Assurance Program. We have experienced people to manage your submissions in compliance with all local regulations.
Safety reporting
Patient safety and regulatory compliance are our primary concerns when conducting clinical studies. We work closely with our client's own drug safety department to provide safety surveillance and prompt, accurate reporting of serious adverse events.
Drug Registration
Our qualified registration experts are available to assist in all fields of drug regulatory affairs; we support the evaluation of documents in view of current rules and guidelines, compilation of the complete dossier and the management of the entire registration process.