Study Source One will build electronic source from your vendor platform or we offer a comprehensive range of paper source documents designed to streamline clinical trial documentation. Our customized source forms ensure consistency and accuracy in capturing critical data, including the informed consent process, study procedures, and study-specific information. We include helpful and clear instructions to minimize violations and deviations. By using our design, research teams can efficiently collect source data, maintain regulatory compliance, and simplify monitoring and auditing processes. Our source is designed in a systematic fashion that is easy to follow and navigate for staff, Sponsors/CROs, and Auditors. Leave the timely burden of source creation to us so you can focus on what really matters – the safety of your subjects and the quality of your data.
Study Source One crafts Standard Operating Procedures (SOPs) for clinical research procedures. Our templates are designed to ensure seamless, efficient, and compliant processes throughout your clinical trials by providing clear step-by-step directives. Templates are available for the primary SOPs required by the Sponsor, as well as customized procedures based on your site's needs. Developed with industry best practices in mind, our SOPs help streamline workflows, reduce errors, and maintain the highest standards of quality and compliance. Whether you're conducting a single study or multiple trials, our SOPs empower your team to navigate the complexities of regulatory requirements with confidence and ease.
Our consulting services are dedicated to supporting organizations and individuals involved in clinical trials by providing expertly crafted solutions. We specialize in providing professional consultations, trainings, and evaluations, to ensure CFR and ICH compliance, efficiency, and success at your site.
ARE YOU AUDIT-READY? The FDA typically notifies the site 2-3 days in advance for a not-for-cause audit, versus a for-cause audit when they may just show up at your door unannounced. The FDA's short notice means that maintaining a constant state of readiness is crucial. Relying on sporadic preparations or reactive measures can leave you scrambling when the audit notice arrives, particularly if you haven't been consistently performing controlled quality audits on your source data, EDC, and regulatory binders.
We specialize in preparing sites for audits by evaluating quality assurance observations in your trials, identifying issues that need immediate attention, and providing actionable feedback on other critical study practices. Additionally, we offer comprehensive audit preparation training for Investigators and their staff, covering the key do's and don'ts, and equipping them to confidently respond to inspector inquiries during routine interviews. Early preparation is essential for reducing the risk of receiving an FDA Form 483 or warning letter, a challenge that affects nearly one-third of investigators. Let us proactively help you and your team achieve audit readiness.
We offer a variety of consulting services. If you don’t see it specifically listed here, contact us, and we may be able to assist you with your research needs. Our team of industry experts is here to ease the burden of the complexities of clinical trial processes.
Contact us today to learn more about how our services can benefit your site, assist you with challenges, and alleviate your research burdens