Atlantic Research Group is a global, full-service CRO with a focus in rare/orphan indication clinical programs. At ARG, we know how difficult it is to develop an orphan drug. But, we also know that great things happen when passionate people combine their strengths. Together, we create smart, feasible studies with protocols that reflect everyday life. We connect individuals—even if there are only 50 in the entire world with a particular rare disease—to organizations that have the drive and know-how to develop potential treatments. We uncover far-reaching insights in orphan drug research, no matter how limited data may be. Let’s unite and finish the journey from trial to treatment.
Atlantic Research Group is your partner in navigating the clinical trials process. Your business goals are our highest priority. We don't simply 'manage' your study, we help you develop the protocol, select and manage sites, recruit patients and investigators, implement clinical systems, plan for regulatory changes, and devise drug safety programs.
Our customer and investigative site-focused methodology, utilized across projects of all sizes and complexities, is driven by results. Our Project Managers take advantage of the full capabilities of the TrialVista® software suite to effectively start, manage, and close your clinical study within the specified timelines. Each Project Manager works closely with our clinical teams and reports directly to ARG senior management to ensure that the project is completed on time and within budget, while maintaining the safety of each study volunteer. Specific capabilities include project planning, implementation and management, project status reporting, customer and site relationship management, interdepartmental resource planning, vendor identification and management, budget and contract management, and team training and evaluation.
Experienced and qualified clinical investigators are not always easy to identify — and without the right investigators, your trial will likely face enrollment issues. We've developed a broad network of investigators across numerous therapeutic areas, and we can quickly identify the most suitable investigators so that your trial can be up and running as quickly as possible.
Atlantic Research Group is a full-service CRO, offering medical writing and regulatory services, including but not limited to the following:
We have a comprehensive understanding of both FDA and EMA regulatory models, and we have conducted multi-country studies as part of our Global Perspectives.
Atlantic Research Group's comprehensive clinical trials experience includes approaches and techniques well-known throughout the industry for their difficulty and complexity. In over 10 years of clinical trial management services, ARG has designed/implemented sophisticated protocols, including MTD/DLT, pharmacokinetic analysis, and Data and Safety Monitoring Board interaction. Our innovative approach includes adaptive trial methodologies: statistical analysis is one of the most powerful tools in our portfolio for maximizing protocol design value, trial efficiency, and confirmation prospects.
At ARG, we believe that sponsors need not depend on their CRO for data requests: we give you the ability to access your clinical data and analytics, with realtime updates, from any device, platform, or browser. We believe this open architecture also fulfills the Sponsor's requirement of free access to clinical data, outside of our systems and applications. ARG makes your data available for download, display, and analysis in other applications (e.g. Excel and SAS/R/MatLab). Our systems are extensible with built-in APIs that allow bidirectional data exchange with other systems because we do not hold our clients' data hostage - we set it free.
The Physician Payments Sunshine Act (Sunshine Act) requires manufacturers of drugs, medical devices and biologics that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. TrialVista® makes reporting for FPSA a simple process: the application allows the export and communication of invoice data via a few clicks.
Our mission is to provide our clients with a division of safety professionals that can comply with global regulations, operate under GVPs and exceed expectations for safety services. By supporting the safety of our subject’s through superior pharmacovigilance expertise and employing experienced professionals, we help support our clients with the successful and safe delivery of a product. Drug safety is integrated into our functional service groups which allows ARG to better serve our clients as a resource from clinical trial development through all phases of a product life-cycle. We utilize known and validated systems as well as innovative processes to obtain and maintain accurate, up-to-date and complete safety information which helps ensure unbiased scientific safety information is available to all stakeholders.
We combine the efforts of physicians and drug safety personnel with innovative systems and operational infrastructure to ensure excellence, transparency and reliability in clinical trial execution. Using the CTMS, TrialVista®, we effectively track and report safety metrics. In addition, we employ the clinical safety case management software ARISg® to manage SAE reporting. ARG is capable of supporting the unique safety needs of products and devices through our technological versatility and knowledge.
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