Clinical Operations: From Study Feasibility And Recruitment To Trial Monitoring And Quality Assurance
Our Approach
At Southern Star Research, we have extensive experience across all aspects of clinical operations and a wide range of therapeutic areas. We specialize in providing flexible, high-quality, and custom solutions that help you deliver regulator-ready data on time and at a predictable price.
As a large proportion of our clients are geographically dispersed, we understand how important it is to be able to trust that your CRO is working in your best interests. That’s why we pride ourselves on building strong, transparent, and close relationships with our clients.
Our team of experts will guide you through the clinical trial process using a proactive and collaborative approach, ensuring that your stakeholders are always informed, in control, and confident throughout the journey.
Site Management and Monitoring
Our site management and monitoring team, within the clinical operations department, consists of expert Clinical Research Associates (CRAs) with a broad range of experience across different therapeutic areas, phases, and intervention types. A highly skilled CRA plays a crucial role in ensuring the success of a clinical trial by:
-
Monitoring compliance with regulations and protocols
-
Identifying and managing safety issues
-
Maintaining data quality and integrity
-
Identifying and mitigating risks
-
Ensuring investigator and site compliance
-
Facilitating site communication and collaboration
Developing and maintaining strong relationships with sites comes naturally to our CRAs. A respectful and trusting relationship enables all aspects of site management and monitoring to be conducted efficiently. Working closely with sites (and other vendors) assists with timely recruitment, whether that be healthy volunteers or the more complicated type of participants.
We have Clinical Operations Staff throughout Asia Pacific, including Australia, New Zealand, Philippines, Malaysia, Singapore, South Korea.
Accelerating Clinical Trial Site Activation
We are deeply committed to activating your trial sites as quickly as possible. We understand the importance of time in the clinical trial process and strive to incorporate efficiencies and economies of scale at every opportunity without compromising quality. Our dedicated site liaison team will handle all aspects of site start-up, including site identification, site feasibility, ethics, regulatory, budget, and contract negotiations. With our streamlined study start-up process, we can help you achieve accelerated timelines, reduction in costs, and deliver new treatments to patients sooner.
Study Feasibility
We conduct in-depth site feasibility assessments, identifying the right sites with the right participants to meet your project’s specific needs.
Leveraging our well-established and extensive network of engaged investigators and key study sites ensures timely, comprehensive, and accurate responses, including:
-
Health condition incidence/Disease states
-
Treatment patterns
-
Protocol design
-
Participant recruitment rates
-
Competing studies
-
Site resource and facilities
With over 50 years of combined industry experience, our site liaison team goes above and beyond to identify sites that deliver both quantity and quality.
Site Relationships
Our site liaison team invests the time needed to build and maintain site relationships through mutual trust and respect. We promote open and timely communication to foster collaboration with investigators and study site teams.
Project Management
Our team of Project Managers are among the most experienced in the Asia-Pacific region. With a focus on building proactive relationships with our clients, sites, and investigators, you can rely on them to drive your study forward and strive to deliver reliable data rapidly, and within budget.