Consulting Services
1. Regulatory & Compliance Consulting
We help clinical trial sites and sponsors maintain audit-ready documentation through customized regulatory consulting. From TMF quality checks to SOP development and site startup packages, our services ensure your team is compliant, efficient, and prepared for inspection. Key Services:
- TMF audits and gap assessments
- SOP development & customization
- Site readiness planning
- Regulatory binder setup
- Central file cleanup & QC
2. Trial Participant Support Hub
We provide tools and resources to help patients understand clinical trials and feel supported every step of the way. From preparing for informed consent to navigating transportation or follow-up visits, we make participation more accessible, inclusive, and compassionate. Key Services:
- Consent form explainers & Q&A tools
- Printable trial prep checklists
- Patient-friendly explainer videos
- Reminder templates for coordinators
- Resource kits for new enrollees
3. Digital Template & Resource Store
Our ready-to-use regulatory templates are designed for clinical researchers, coordinators, and startup sites looking to streamline operations. From CV formats and DOA logs to TMF QC checklists and SOPs, each tool is professionally formatted and trial-site ready.
Key Services:
- TMF QC checklist templates
- Investigator CV format templates
- SOP and log templates
- Regulatory start-up checklist
- Editable Word/PDF forms
OnePath Research Services
Regulatory support that keeps trials moving.
TMF Audits & Gap Assessments
We review your Trial Master File for completeness, accuracy, and compliance, identifying missing or outdated documents.
SOP Development & Customization
We create or refine Standard Operating Procedures to match your workflows and meet GCP and sponsor expectations.
Site Readiness
Planning
From pre-study visits to mock audits, we ensure your site is fully prepared for activation and regulatory review.
Regulatory Binder
Setup
We build or organize essential site binders with standardized, compliant documentation.
Request a no-cost site
assessment with OnePath.
Ready to streamline your research operations or support your clinical trial participants with confidence? Connect with OnePath Research Services for expert guidance, audit-ready tools, and compassionate support tailored to your needs.