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.
EU Legal Representation Services
The European Clinical Trials Directive (2021/20/EC) indicates that a Sponsor conducting a clinical trial in the European Union must either have a registered office within European Economic Area (EEA) territory, or work with a legal representative with an established office within the EEA community.
With an office in Amsterdam that specializes in complying with directives released by the European Medicines Agency (EMA), ARG is an ideal choice to serve as your legal representative in Europe.
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.