Our Services

We offer comprehensive regulatory management services designed to simplify every phase of the study lifecycle.

Full-stack Consulting Services
(FCS = TSA, CBN, SOPs, TRS, SDT)

Comprehensive Checklist for Site Readiness

A step-by-step checklist outlining all tasks required to prepare your site, including:
‍

  • Establishing study binders and logs.

  • Creating workflows for subject recruitment and retention.

  • Subscription to Triallogix Recruitment Services are available and optional

Assistance with operational setup, including identifying and assigning clinical trial responsibilities.
Protocol and Equipment Consultation

  • Guidance on study protocols to ensure your site meets the requirements for study-specific objectives.

Recommendations on equipment and facilities necessary for specific studies.
Research Site Operations Training

  • Covers essential topics such as informed consent processes, source documentation, and adverse event reporting.

Remote support for ongoing site operations via Slack M-F 9 AM-4:30 PM PST
Triallogix Study Acquisition (TSA)

  • Sourcing appropriate diagnostic & therapeutic clinical trials

  • Functions as an extension of the clinical site in Business Development to build clinical trial pipeline

Contract and Budget Negotiation (CBN)

  • Coordinating study start-up agreements

  • Negotiating trial budgets on behalf of the clinical trial site

  • Maximize budget potential and revenue by utilizing Triallogix’s expertise in market rates of procedures and invoiceable items

Standard Operating Procedures (SOPs)

  • Standardized SOPs readily adaptable to the needs of your research site to ensure consistency, compliance, and operational efficiency.

Triallogix Regulatory Services (TRS)

  • Training and Certification

    • Good Clinical Practice (GCP) Training: Ensures compliance with regulatory standards and equips your team with the knowledge to conduct ethically sound and high-quality research.
    • IATA Training: Ensures your staff can handle and ship biological samples in accordance with international guidelines.

  • 1572 and Delegation log generation and maintenance

  • Cloud regulatory document storage and management

Source (Paper) Document Templates (SDT)

  • Expedite clinical site readiness utilizing Triallogix developed templates:

    • Screening
    • Randomization
    • Follow up visit
    • End of study

Recruitment Strategy and Implementation (RSI)

Comprehensive, data-driven recruitment strategy accounting for:

  • Local demographics, income levels, ethnic diversity, consumer media behavior

Develop patient-friendly, dynamic and engaging creatives to catch the eye of potential clinical trial participants
Social media ad posting and management on platforms such as Facebook, instagram, etc.

Frequently
Asked Questions

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.

Compliance Simplified,
Success Amplified

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

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