Since each project requires a unique solution to run effectively, we operate on a philosophy we call “strict flexibility” – strict in our attention to detail and quality, flexible in our chosen approach. The result is that we meet each client’s needs in the most logical and efficient manner possible, solving existing problems while simultaneously looking ahead for issues that may not have been anticipated.
Clinical Operations Management
Aris clinical operations managers provide operational oversight for study teams or departments to ensure quality, productivity and efficiency while meeting client objectives.
Operational management tasks are tailored to meet specific client needs including management of project budgets, timelines, and resources, development of Standard Operating Procedures (SOPs), and negotiation and management of vendor contracts and budgets.
When it comes to outsourcing, one size does not fit all.
Aris understands the complexity of clinical trials and how to address clinical outsourcing needs. Based on assessment of client resources, infrastructure, and trial design, including complexity, region, phase, and size, Aris management provides candid guidance and advice for each client’s outsourcing requirements.
Monitoring and Site Management
Efficient, experienced clinical monitors are essential to a successful trial. Clinical Research Associates (CRA) are on the front line – evaluating and selecting sites, assisting with site management, and making critical decisions that will affect the outcome of your project.
Like everything at Aris, our CRAs are held to a higher standard – averaging more than 10 years of experience in challenging therapeutic areas including oncology, autoimmune disease, and HIV. Depth of experience means your trial will be up and running quickly, managed capably, and closed out efficiently.
Flexible Staffing Solutions
Aris management has extensive clinical trial management experience, allowing for successful identification, management, mentoring, and retention of personnel needed for each client’s project.
Using a flexible staffing model, Aris provides personnel to support variable workload and talent needs, including virtual, regional and on-site options. From start-up to closeout, our collaborative study teams deliver, no matter the project size.
Aris study managers possess an average of 15 years clinical research experience. Their expertise spans a variety of therapeutic areas and the practical logistics of trial management. With backgrounds and extensive work experience in pharma and biotech companies, as well as large CROs, our project managers are well versed in study start-up, site selection, effective monitoring practices, and site and personnel management.
Our managers coordinate all aspects of the trial process, including budget development, creating and managing timelines, writing regular status reports and enabling communications between the client and team members. They manage other study vendors, such as central labs, central institutional review boards (IRB), and data management groups – all of the vital components that contribute to the success of a clinical trial. This primary point-of-contact model saves time, reduces cost, and streamlines the decision making process.
Clinical trials can go awry for a variety of reasons – poor study design, inadequate expertise, or lack of resources. Whatever the reason, your primary concern is saving the project, and so is ours. At Aris we recognize that if a trial misses its deadline by even a few weeks, the result can be significant loss of revenue and company-wide disruption.
Aris’ diligence, experience, and intense focus on the clinical trial process have resulted in the successful rescue of several such projects, including complex studies in oncology and ADHD. Tasked with righting troubled clinical trials in the most trying of circumstances, Aris has delivered for our clients, on time, every time.
When your clinical trial needs help, Aris is uniquely qualified to put things back on track.
Centralized Data Review
The Aris Data Review Team (DRT) augments Clinical Science and On-site Monitoring by conducting centralized review of study data, utilizing data listings, patient profiles, EDC, and/or other data sources. The DRT identifies data issues in a timely and efficient manner, providing sponsors significant value as a supplemental modality in achieving the data quality needed for critical data lock milestones.