We create Source Documents, SOP's, and provide Consulting Services for Research Sites and Investigator Initiated Studies
Reduce time, effort, and cost for all of your phase I-IV clinical trials. We will create your e-source or paper documents from the protocol, from simple to complex. Our source is easy to navigate, consistent, in compliance with the Code of Federal Regulations, ICH E6, ALCCOA+ guidelines, and provides helpful and clear instructions to the staff to minimize violations and deviations.
Do you need to create or modify SOPs while ensuring they are in compliance with the Code of Regulations and ICH E6 Guidelines? We will provide you with templates for the primary SOPs required by Sponsors.
If you need specific SOP's, we can create and customize them to suit your needs.
With 25+ years in the research industry, you can trust that our experience will help you with any clinical research questions or concerns you may have. If you are new to research, an Investigator initiating a study, or are experiencing challenges at your site, rest assured that we can help navigate you and your team to streamlined process
With 25+ years in the research industry, you can trust that our experience will help you with any clinical research questions or concerns you may have. If you are new to research, an Investigator initiating a study, or are experiencing challenges at your site, rest assured that we can help navigate you and your team to streamlined processes in compliance with regulations. We provide evaluations, interactive training to staff and Investigators, among many other consulting services. Web conferences and in-person meetings are available.
Contact us today to learn more about how our services can benefit your site, assist you with challenges, and alleviate your research burdens