Study Start-Up Regulatory aligned clinical research for medical device
Clinical Trials Supported
Participating Patients
Satisfied Clients
How ABRS Leads Innovation in Medical Device Testing Services
Global study start-up services at ABRS are designed to accelerate clinical development with precision, compliance, and global oversight. We guide sponsors from initial planning to site activation and beyond, ensuring that every step of the start-up process is executed with efficiency and regulatory alignment. By combining innovation with operational expertise, ABRS delivers solutions that minimize delays, maximize site readiness, and set the foundation for successful clinical trials.
At ABRS, we understand that a smooth study initiation is critical to overall project success. Our integrated approach leverages best practices, local regulatory knowledge, and global FSP capabilities to deliver consistent results. Whether managing submissions, site contracts, or essential document collection, our experienced team ensures that study start-up activities align seamlessly with sponsor objectives and strict compliance requirements, including FDA and ICH-GCP guidelines. This makes our global study start-up services both adaptable and reliable across diverse markets.
With advanced systems and a commitment to regulatory excellence, ABRS provides sponsors with transparency, confidence, and speed. Through streamlined workflows and proactive oversight, we deliver reliable start-up support that adapts to both single-site and complex multi-country trials. By integrating local expertise with global oversight, our global study start-up services ensure high-quality outcomes and accelerated timelines—advancing healthcare innovation worldwide.
Global Study Start-Up Services with FSP Flexibility
Global study start-up services at ABRS are reinforced by our flexible Functional Service Provider (FSP) model, giving sponsors scalable resources that adapt to the complexity of their programs. This approach allows us to integrate seamlessly into sponsor systems while maintaining ABRS quality standards, ensuring operational consistency across all regions. The FSP model combines the efficiency of outsourcing with the oversight of in-house management, making it an ideal solution for global clinical trials.
Our global study start-up services cover every critical step, from feasibility assessments and regulatory submissions to site contracting and activation. With deep regulatory expertise and proven global delivery, ABRS helps sponsors navigate diverse requirements while ensuring full compliance with ICH-GCP and FDA standards. Whether for early-phase studies or large-scale, multi-country programs, we ensure start-up is completed on time, on budget, and with the highest quality.
Ultimately, our global study start-up services provide sponsors with the assurance that every trial begins on a strong foundation. By trusting ABRS to deliver tailored, high-quality start-up solutions, sponsors gain a partner committed to minimizing risk, accelerating timelines, and achieving clinical development goals. Because in clinical research, getting started right is the key to long-term success.
FAQ's
ABRS offers a comprehensive range of services, spanning from study start-up to close-out, and effectively covering various phases of clinical research. In particular, this includes support for first-in-human trials, dose-ranging studies, and pivotal trials. Moreover, our flexible approach allows us to adapt to your specific project needs at each stage. As a result, you gain consistent, high-quality support throughout the entire clinical development process.
ABRS provides critical insight, dedicated support, and proven best practices to ensure the success of clinical trials. In addition, our team works closely with you to anticipate challenges and implement effective solutions. Moreover, our commitment is to offer strategies that empower you to innovate with confidence, seize opportunities, and propel your clinical trials forward. As a result, you gain a reliable partner focused on advancing your research with precision and impact.
ABRS distinguishes itself by offering a broad spectrum of services that comprehensively covers the entire clinical research process. In fact, we go beyond traditional support by delivering not just services, but also critical insights that empower our clients to navigate challenges with clarity. Moreover, we focus on enabling informed decisions through proactive guidance and deep industry expertise. As a result, our clients experience greater efficiency, reduced risk, and improved outcomes throughout every stage of the clinical trial lifecycle.
ABRS is dedicated to facilitating innovation in clinical research. Not only do we provide support for various phases of research, but we also aim to enhance strategic opportunities for our clients. In addition, we tailor our approach to meet the evolving demands of each project. As a result, our clients benefit from greater flexibility, efficiency, and oversight. Moreover, our goal is to drive clinical trials forward by ensuring that clients can navigate the complexities of the process with clarity and confidence. Ultimately, we help turn innovation into measurable progress.
ABRS has extensive experience in conducting clinical research in fourteen countries. As a result, our global reach allows us to navigate diverse regulatory environments with precision and agility. In addition, we adapt to local requirements while maintaining global standards of quality and compliance. Therefore, we ensure seamless and fully compliant clinical trials, regardless of geography. Ultimately, our international expertise translates into consistent execution and successful outcomes for our clients.
ABRS boasts a highly skilled and experienced professional team dedicated to clinical research excellence. In fact, our team members bring diverse backgrounds and specialized expertise, collectively contributing to successful outcomes across various phases of clinical trials. Moreover, their collaborative approach ensures alignment with project goals and regulatory expectations. With years of experience, they navigate complexities with confidence and precision. As a result, clients gain the assurance needed to overcome challenges in the ever-evolving landscape of clinical research. Ultimately, our people are the foundation of our performance, driving quality and innovation at every step.
North America
.
Europe
.
Asia-pacific
.