Medical Writing Services
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Functional Service Provider (FSP) Medical Writing Services | ABRS
At ABRS, we specialize in delivering high-quality Medical Writing Services through a Functional Service Provider (FSP) model that supports sponsors and CROs worldwide. Our methodology is based on flexibility, scalability, and regulatory compliance, ensuring research teams can accelerate timelines without compromising on accuracy or quality. By embedding our expert medical writers directly into your teams, we guarantee seamless collaboration, efficient processes, and consistent delivery of the essential documentation required to advance clinical development.
Why Choose ABRS Medical Writing Services?
In today’s complex clinical research environment, success depends on more than just collecting data. It requires transforming data into clear, structured, and compliant documents that regulators, investigators, ethics committees, and stakeholders can trust. Our Medical Writing Services are designed to help sponsors and CROs achieve this critical objective, reducing risks and ensuring every piece of documentation supports the integrity of your research.
At ABRS, our writers bring extensive experience across multiple therapeutic areas and have a global perspective on clinical research. We prepare study protocols, clinical trial reports, investigator brochures, informed consent forms, patient narratives, and regulatory submissions with precision and consistency. This ensures your research is scientifically sound and aligned with the expectations of international agencies such as the FDA, EMA, MHRA, and other regulatory authorities.
A Flexible FSP Model for Every Research Need
One of the major advantages of working with ABRS is the adaptability of our FSP model. Every sponsor and CRO faces unique challenges, which is why we provide a range of engagement options tailored to your operational goals. Whether you need full-time dedicated writers embedded within your team, temporary support during periods of peak workload, or scalable capacity to cover multiple global studies, we adjust our services to fit seamlessly into your processes.
This flexible model offers several key benefits:
Scalability: expand or reduce writing capacity based on study demands.
Consistency: maintain a unified tone, style, and structure across multiple submissions.
Compliance: ensure every document follows ICH-GCP guidelines and international regulatory requirements.
Efficiency: prevent bottlenecks in document preparation and safeguard study timelines.
By operating as an extension of your team, ABRS helps reduce the burden on internal resources and ensures that every document is delivered on time, fully compliant, and ready for submission.
FAQ's
ABRS offers a comprehensive range of services, spanning from study start-up to close-out, covering various phases of clinical research. This includes support for first-in-human trials, dose-ranging studies and pivotal trials.
ABRS provides critical insight, support, and best practices to ensure the success of clinical trials. Our commitment is to offer solutions that empower you to innovate with confidence, seize opportunities, and propel your clinical trials forward.
ABRS distinguishes itself by offering a broad spectrum of services that covers the entire clinical research process. We go beyond traditional support, providing not just services but also critical insights to help our clients navigate challenges and make informed decisions.
ABRS is dedicated to facilitating innovation in clinical research. We not only provide support for various phases of research but also aim to enhance opportunities for our clients. Our goal is to drive clinical trials forward by ensuring that our clients can navigate the complexities of the process with confidence.
ABRS has extensive experience in conducting clinical research in fourteen countries. Our global reach allows us to navigate diverse regulatory environments, ensuring seamless and compliant clinical trials.
ABRS boasts a highly skilled and experienced professional team dedicated to clinical research excellence. Our team members bring diverse backgrounds and expertise, collectively contributing to successful outcomes across various phases of clinical trials. With years of experience, they navigate complexities, providing clients with the confidence to overcome challenges in the ever-evolving landscape of clinical research.
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