Regulatory timelines in the Asia-Pacific

An at-a-glance round-up of the arrangements for clinical trial applications in 10 countries in the region. Australia Australia is unique in that its Human Research Ethics Committees (HRECs) have responsibility for the oversight and ongoing monitoring of trials, including reviews and approvals. The first step is submission of the clinical trial to the HREC for […]

Read More

China’s dynamism requires a nimble CRO with extensive research networks

China’s meteoric growth over the past twenty years (or so) has seen it go from strength to strength, particularly in the clinical trials sector. As the clinical trial market of the world’s most populous nation (and second largest economy) continues to mature, so does their regulatory requirements. These regulatory adjustments pose a risk to sponsors […]

Read More

George Clinical Awarded Contract for Clinical Trial Management Services on Rotavirus Vaccine

George Clinical has recently been awarded the contract for full service clinical trial management services for a clinical study that seeks to improve the formulation further and also the current administration challenges for a rotavirus vaccine. The vaccine was recently launched by Indian Prime Minister Narendra Modi and developed by a Hyderabad based healthcare organization […]

Read More

Benefits of DPPIV-inhibitors still uncertain

The recent SAVOR-TIMI 53 (saxagliptin) and EXAMINE (alogliptin) trials recently reported the effects of the DPPIV inhibitor class of glucose lowering agents in people with diabetes. As required by the US FDA, both drugs were found not to increase cardiovascular risk, allowing the agents to be registered for use in that country. Good news, it would […]

Read More

Twitter Facebook LinkedIn