FAQs

Triallogix specializes in completing, submitting, and managing regulatory documents for clinical research sites. We ensure accuracy, compliance, and timely delivery of essential regulatory documentation.

We handle a wide range of documents, including but not limited to:
• 1572 Forms
• Financial Disclosure Forms
• Investigator CVs and Licenses
• Protocol Deviation Reports
• Safety Reports
• IRB Submission Packets
• Study Start-Up Documentation

Our team of regulatory experts stays updated on the latest FDA, ICH-GCP, and IRB guidelines. We use quality assurance checks to ensure all documents meet regulatory standards.

Clinical research sites, including independent sites, hospital-affiliated sites, and multi-site research organizations, can benefit from our streamlined approach to regulatory document management.

Yes, we can integrate with your current processes and use your preferred systems or templates to ensure a seamless workflow.

The timeline varies based on the complexity and volume of documents. However, we pride ourselves on quick turnarounds and clear communication about timelines.

Our sole focus is on regulatory documents, allowing us to specialize and deliver unmatched expertise. We streamline processes, minimize errors, and save your team valuable time.

Yes, we provide ongoing support for amendments, annual reports, and other regulatory needs throughout the duration of your study.

We offer customizable pricing options depending on the scope of your project, including flat fees for specific document preparation and subscription-based services for ongoing support.

You can schedule a free consultation through our website. During the consultation, we’ll discuss your needs and create a customized plan to support your research site.

While our primary focus is on document preparation, we can provide guidance and best practices for maintaining regulatory compliance. Please reach out to us at info@triallogix.io so we can discuss your needs!

We offer expedited services for urgent regulatory needs. Contact us to discuss your requirements, and we’ll work to accommodate your timeline.

Currently, our services are tailored to U.S.-based clinical research sites, but we are knowledgeable about ICH-GCP standards that apply globally.

Yes, we are equipped to manage regulatory documents for multiple studies simultaneously, ensuring efficiency and consistency.

We use secure, encrypted systems for data transfer and storage. Our team undergoes regular training on data privacy and compliance standards.

We assist in archiving your regulatory documents in compliance with industry standards and can provide guidance on closeout procedures.

You can reach us through our contact page or email us at info@triallogix.io. Our team is happy to assist with any questions or concerns.