CTA Focus is comprised of a young and dynamic team
of talented professionals, seasoned of both regulatory nuances and the pharmaceutical environment as they pertain to the Clinical Trial Agreement template development process.
Our team can assist with all stages of development
(project management), including drafting and reviewing agreements (confidentiality, Privacy, supply etc), advise on regulatory requirements and industry standards governing Clinical Trials such as ICH Guidelines and GCPs, European Directive 2005/28/EC and all applicable laws.
We possess a strong set of country specific templates
which allows us to combine a smooth negotiation process while protecting the legal interest of our customers and of the sites that we work with.
Our templates are up to date with country specific requirements
and have a clear structure to accommodate our clients' need/requirements.
We can draft and review agreements
including confidentiality, privacy, supply, and other related clinical trial agreements and advise on new regulations and industry standards governing clinical trials, such as ICH Guidelines and GCPs, European Directive 2001/20/EC and Directive 2005/28/EC and all applicable local laws.