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FAQs

You have questions? We have answers. If you have other specific questions, please reach out to us at info@triallogix.io

What services does Triallogix provide?

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

What types of regulatory documents can Triallogix assist with?

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

How does Triallogix ensure compliance with regulations?

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.

Who can benefit from Triallogix services?

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

How does the Triallogix process work?

Step 1: Initial consultation to assess your needs.
Step 2: Collection of required information and documents.
Step 3: Preparation and review of regulatory documents.
Step 4: Submission to the appropriate regulatory body or sponsor.

Can Triallogix work with my existing regulatory systems or templates?

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

How long does it take to complete regulatory documents?

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

What makes Triallogix different from other regulatory services?

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.

Do you offer ongoing regulatory support for active studies?

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

What is the cost structure for Triallogix services?

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.

How do I get started with Triallogix?

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.

Does Triallogix provide training or consulting on regulatory compliance?

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!

How do you handle urgent requests?

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

Is Triallogix available to support international clinical trials?

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

Can you work with multiple studies at once?

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

How do you ensure data security?

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

What happens if my study closes or is canceled?

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

Who do I contact if I have additional questions?

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.

Compliance Simplified,
Success Amplified

Avoid delays, increased costs, and potential compliance risks when you partner with Triallogix.

Get Started

info@triallogix.io

657-216-1255

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Fullerton
1440 N. Harbor Blvd. #917
Fullerton, CA 92835

FAQs

Compliance Simplified,Success Amplified

Compliance Simplified,
Success Amplified