ARG focuses on understanding your needs, implementing solutions to meet them and, most important, delivering what we promise. Our core service offerings give clients proven capabilities for meeting the key challenges of the clinical trial process. We've honed our services through years of hands-on drug development experience, and organized them to provide the most value with the greatest ease of delivery.

Project Management

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.

Clinical Monitoring

Our dedicated Clinical Monitoring Team, along with our Trial Site Managers, serves as the liaison between the investigative sites and our client. It ensures that all study volunteer rights have been respected, all study data is complete and accurate, and each investigative site remains compliant with the protocol in accordance with all local and federal regulations.

Each ARG Monitor is trained in FDA and ICH/GCP regulations, TrialVista software, and ARG's internal monitoring SOPs. Clinical Monitoring services are available across phases (including post-market analyses), and in proactive communication visits to enhance site relationships and recruitment.

Investigative Site Management

With a strong focus on building better site relationships and enhancing team communication, our Trial Site Managers (TSMs) provide the critical link between our clients and participating investigative sites.

Frequent, focused and proactive contact between TSMs and Clinical Research Associates within investigative sites is the key to enhancing clinical production at the site level. TSMs are also responsible for all regulatory start-up tasks, including essential document packet submission and processing, regulatory document review and sign-off, IRB submission assistance, feasibility study conduct and management and screening and enrollment tracking.

TSMs are thoroughly trained on the TrialVista software system and serve as primary customer service associates. They assist sites with any user inquiries and are the liaison for the software reporting processes.

Regulatory Document Maintenance

We provide a complete set of document management services, including start-up collection, interval and long-term storage, maintenance and final submission of all essential regulatory documents, CRFs, and all other study related documents. Our secure storage facility is equipped with state-of-the-art security monitoring and filing systems.

Investigator & Patient Recruitment

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.

Quality Assurance

Clinical Trial Management System (CTMS) Development

We've developed our own CTMS system, TrialVista®. Which brings together everything we've learned from successful clinical trial projects. To learn more about TrialVista, view our demo here.

Expertise and Management across the Clinical Trial Process

We augment our in-house clinical trial expertise with a range of specialized support services from leading industry providers, fully integrated with our offerings and overseen by our experienced staff. In this way, we're able to provide our clients with a comprehensive solution and act as a single point of contact for the effective implementation and management of the entire clinical trial process.

• Data Management
• Electronic Data Capture
• Biostatistics
• Medical Writing
• Drug Safety