ARG has the experience and people to overcome regulatory trial challenges.Tell Us About Your Needs
White glove sponsor walk-throughs of regulatory requirements and legal process.
Vigilant awareness of regulatory updates and communication of relevant legal requirements.
Regular check-ins to ensure compliance with Good Clinical Practice (GCP) specifications.
Scheduling of key site inspections to comply with International Conference of Harmonisation (ICH).
Creation of customized solutions for each sponsor to ensure compliance in host countries.
Trial authorizations and submissions prepared with Ethics Committees and National Competent Authorities.
ARG is continually tasked with being the best legal representation possible. Regulations inevitably change and sponsors sometimes ask, “Did the governing body really mean that?” or “What are we supposed to do to remain compliant?”
ARG must be a reliable legal expert who is both in the know about today’s dynamic EU landscape and provides quality assurance oversight across the full extent of the trial, including linked trials outside the EU.
ARG provides individualized solutions based on expertise and experience. We gather key facts, such as phase of study, therapeutic area, countries, number of sites, and the length of trial, to then provide representation suited to the precise needs of the sponsor and the study.
We also build a structure that can be maintained throughout the cycle of the partnership, focusing on next-level considerations, such as explaining the legal implications of managing a single project vs. a multi-step program, then planning and executing the best way forward.
For more than 20 years, sponsors who have engaged our legal services have rested assured that we have the process in place to ensure compliance and oversight of their trials. We have the ability, personnel, and knowledge to run trials to the applicable standards and regulations.