Clinical Operations & Project Management

Our highly skilled team is dedicated to forging strong partnerships with our sponsors, ensuring that the studies are conducted within constraints of timelines and budget while ensuring the upmost quality. With a comprehensive range of clinical operations activities from study start-up to close-out, our team consists of experts who have successfully conducted numerous studies in a broad range of therapeutic areas, ranging from small, specialised investigations to multinational pivotal trials.

One of the key drivers to success for your trial lies in our relationships with sites within our clinical research network. With Key members of our team previously working at trial sites, we understand the importance of good communication and collaboration with key stakeholders. This provides us with an opportunity to consult with key opinion leaders to help develop your study early on to ensure trial success. With this deeper understanding of site capabilities and limitations, we can select the most appropriate sites for your trial.

Leveraging our extensive knowledge of sites across Australia, we conduct thorough feasibility assessments for your study. This includes obtaining valuable feedback on protocol design, suitability of the study in terms of disease treatment and standard-of-care, as well as recruitment rates and timelines.

Our clinical operations and regulatory affairs teams work collaboratively to ensure an efficient and seamless start for your study. With quick turnaround times of 5-6 weeks, we are able to provide valuable insights into the appropriate regulatory strategy, eg, CTN versus CTA. Our experienced team is aware of the scientific and regulatory requirements that will expedite successful review and approval of your study by the relevant Human Research Ethics Committees.

At our core, we are committed to delivering exceptional service and driving the success of your clinical trials. Let us be your trusted partner in achieving your research goals.

Whether you are looking for a full-service clinical research partner or just need support in one specific area, our team at GLC is ready to help you achieve your goals. Contact us today and see how we can help you achieve your goals.