Safety monitoring and reporting in clinical research trials ensure both patient safety, data integrity, and regulatory compliance.
Strict regulatory guidelines on clinical trial safety monitoring and reporting necessitate the preparation and implementation of study-specific safety monitoring and reporting strategies and procedures.
Our safety monitoring and reporting services help you ensure regulatory compliance, with optimal efficiency at a reasonable cost.
As a leading Australian CRO, our clients benefit from our regional regulatory knowledge, quality systems approach multi-disciplinary safety expertise, and adherence to reporting timelines of the Australian Therapeutic Goods Administration (TGA) and other competent authorities.
Our Statistical and Pharmacokinetics Services include:
Avance Clinical offers complete study-specific safety reporting services, which include data collection, processing, review, safety report writing, and reporting. Our dedicated safety monitoring and reporting team comprise highly skilled individuals with in-depth knowledge in diverse therapeutic areas and several years of clinical trial safety management services experience.
The Government R&D grant means up to 43.5% rebate on clinical trial spend
Site Initiation Visit (SIV) and Study Start achieved in 5 – 6 weeks
Full service CRO in Australia and New Zealand
“Avance Clinical’s clients are international biotech companies primarily from the United States, United Kingdom, Japan, China, South Korea, Taiwan, France, and Germany. These clients are seeking a premium CRO with the same experience and advanced technology platforms offered by the major global CROs, but with an agile and customer focused approach to clinical management in Australia and New Zealand.”
Supriya Lala KunduBest Practices Research Analyst, Frost & Sullivan
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