ARG has extensive Phase I experience across a variety of therapeutic areas including diabetes, oncology, ophthalmology and healthy volunteer studies. We have several established relationships with Phase I clinics both in the US and outside the US.
Our project management team has effectively navigated the unique challenges of Phase I development and stand ready to draw on our past experiences for your program.
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.
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.
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.
The quality and integrity of data is vital to any clinical trial. Thats why ARGs data management team is committed to the delivery of accurate data management solutions that are customizable to each clients requirements. Our solutions are cost effective, secure, compliant and expedite the data collection process.
Our Data Management team is involved from the start of the project with data management plan and CRF development through the coding and evaluation and analysis of incoming data. Our data management team is experienced with a variety of systems including SAS, Oracle and Clintrial systems.
ARG utilizes OpenClinica Enterprise, a powerful yet intuitive CDISC compliant Electronic Data Capture (EDC) system that can also manage paper-based and hybrid (eCRF + paper CRF) trials.
Our biostatistics team has experience working with a variety of platforms to meet each clients needs. ARG provides experienced staff to evaluate, organize and present trial information in a timely manner. We are capable of providing full service biostatistical analysis or isolated components such as protocol development, strategic consulting, or quality control and analysis.
ARG can provide a full compliment of Medical Writing and Regulatory support for your programs. Details of services include:
- Protocol development
- Literature review
- Medical writing
- Regulatory strategy and guidance
- Report compilation and writing
- Submission (electronic or standard)
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.
We offer a full range of quality audits for areas such as Clinical Protocols, Database, Investigative Sites, Reports, and Trial Master File (TMF). Whatever the area in question, our experienced team ensures that the quality of your clinical trial will be unmatched.
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.