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.
Adaptive trials may be suitable for your therapy – our statistics experts can design a data collection regime on which to plan incremental change in your trial. Our comprehensive understanding of the intricacies of FDA and EMA regulatory models has resulted in successful multi-country studies. Our founders can and will, fundamentally change ARG to meet your requirements. We know how the scientific attributes of your compound and their effects on its trial will need to be handled, and how the clinical research process must be tailored to your unique innovation.
Meeting International Requirements
In a multi-country hemophilia clinical trial, Atlantic Research Group’s strategic consultancy implemented Polish regulatory requirements efficiently and cost-effectively. Poland’s Ministry of Health and Social Welfare mandates that site contracts must be submitted before the review period.
ARG negotiated a single preliminary site contract, received Ministry approval – which allowed enrollment to begin as soon as possible. The Sponsor met its corporate target date of first patient in the study while concurrently initiating other sites in Poland. ARG in this way enabled the achievement of the Sponsor’s overall country recruitment objectives.
Everyone at ARG has research experience and have established the standard for ARG’s technical knowledge of the chemistry and physics that govern the manufacture, testing, and use of the compounds, materials, and devices you have created.
Addressing Evolving Landscapes
ARG was built specifically to address the evolving landscape of clinical development. Employing highly skilled personnel, best-in-class technology, and senior management engagement in every project. Sponsors often praise our capability to offer clients adaptive trial designs and our track record in addressing complex protocol issues. Biological processes are multifactorial and the controlled perturbation of such complex and often not completely defined systems, is difficult, especially so when constraints upon that action are added in layers. While the previous sentence is true, it may be meaningless to those outside of laboratory science; ARG bridges that gap. ARG understands both the molecular development and clinical trial space. We move molecules, to medicine.