Preparing for a Regulatory Inspection
This document provides a comprehensive overview of how to prepare for regulatory inspections conducted by agencies such as the EMA, MHRA, and FDA.
Download the Ultimate Clinical Trial Tracking Checklist
Connected Site Solutions to Improve Site Training and Productivity
Trial Interactive’s connected Site Solutions include Site Collaboration, Remote Monitoring, eLearning, eISF, Site Training LMS, and Investigator Meetings. All solutions can be accessed through TI Site Portal that’s enabled by single sign-on.
Together, our solutions empower every stakeholder - from sites and sponsors to CROs and IT teams - to be more efficient. By simplifying site training, file management, and collaboration, TI Site Solutions remove the friction from day-to-day clinical operations.
Manage and track certifications in one place with Site Training LMS. Our eLearning experts help you create training content your team will remember and use.
Save up to 95% by eliminating the logistical costs of in-person site training. Our Investigator Meetings add-on for LMS improves training oversight and reduces compliance risks.
Meet multilingual challenges of document translation and collaboration with built-in translation technology. Our Site Solutions are supported by powerful translation capabilities from TransPerfect.
Alleviate manual project management burdens associated with site file management and reviews. Our Remote Monitoring and eISF solutions enable secure site content access anytime and anywhere.
Train teams on study-specific documents and protocols in the LMS and demonstrate compliance to inspectors with certifications. All solutions are 21 CFR Part 11 compliant.
Share knowledge seamlessly and collaborate effortlessly on content authoring and management. Site Collaboration ensures version control and more and eISF allows file access anytime, anywhere.
Reduce administrative burdens of document management by expediting completion of regulatory documentation. Request a Demo >
Centrally and securely manage site-specific files. Use separate, private folders for content containing PHI or PII. Request a Demo >
Easily locate common study reference documents such as protocol, amendments, training materials & manuals by centralizing documentation online. Request a Demo >
Improve visibility with user-friendly dashboards and streamline compliance with 21 CFR Part 11 compliant eSignature workflows. Request a Demo >
Maintain real-time inspection readiness by organizing common site files into study-specific eTMFs. See the full electronic audit trail with a connected eTMF. Request a Demo >
Additional features include: Study links to other central vendor & sponsor portals as needed; separate, configurable folders for content containing PHI; location for common reference documents such as protocol, amendments, training material and manuals; 24/7 help desk; start-up (1572, financial disclosure) document signature workflow; LMS interoperability; 21 CFR Part 11 compliant eSignature, document de-identification and redaction to protect PHI, multiple site access from a single room; study FAQs; configurable site-specific reporting. Request a Demo >
Automatically create and assign training directly from approved documents by role for admin ease of use. Request a Demo >
Archive evidence of training with metadata. Issue certificates of completion, store them centrally, and easily search/sort. Automatically route certificate evidence to eISF folders based on metadata. Request a Demo >
Create personalized eLearning in a user-friendly content library that’s based on your company’s needs. Create engaging knowledge checks to increase retention. Have the support of TI’s eLearning services team. Request a Demo >
Improve training record management with eTMF interoperability. Automatically file site documents in the eTMF. Request a Demo >
Alert sites when they’re missing training requirements. Hold site teams accountable. Ensure compliance with timely completions. Request a Demo >
Course Templates and Compliance Plan Builder; Content Library and Training Catalogs; Training Plans and Groups; Reminder Notifications; Training Management and Tracking; Smart Visual Dashboards; Compliant with Global Regulations; eSignature Training; Completion Verification; Compliance Readiness Dashboard; eTMF Interoperability for Training Records; Content Management Interoperability. Request a Demo >
Secure site documentation and personnel access during remote monitoring for clinical trials. Protect PHI with document de-identification and redaction. Request a Demo >
Enable efficient remote monitoring in clinical trials by reducing travel time and costs for study personnel with controlled, site-specific document access in a single room. Request a Demo >
Secure Site Documentation and Personnel Access; Separate, configurable folders for content containing PHI; Document de-identification & redaction; Multiple site access from a single room with controlled, site-specific document access; 24/7 help desk (email/phone support). Request a Demo >
Reduce in-person training expenses with a remote investigator meeting solution. Easily access training events and resources from your tablet or phone. Request a Demo >
Improve investigator meeting engagement with virtual engagement tools such as polls to collect questions and make the meeting more relevant in real time. Chat with meeting participants and team members with real-time Q&A sessions with attendees, and more. Request a Demo >
Track real-time training completeness by leveraging the site portal to view what training needs to be completed. Easily demonstrate that teams are trained with compliance training records. Request a Demo >
Calendar of scheduled events and sessions to keep track of what training events are ahead; Virtual engagement tools to chat with meeting participants; Mobile-friendly interface to easily access training events and resources from your tablet or phone; polls to make the meeting more relevant in real-time. Request a Demo >
Speed time to document completion by authoring and editing documents by opening MS Word®, Excel®, and PowerPoint® directly in the Site Portal interface. Request a Demo >
Enable secure collaboration with site personnel with document version control feature that ensures site personnel check in to make edits and check out once edits are complete. Request a Demo >
Share completed documents directly with the connected eTMF, eliminating additional document capture activity. Request a Demo >
Single portal to share and collaborate on clinical documentation; Author documents by opening MS Word®, Excel®, and PowerPoint® directly from the interface; Collaborative Authoring tool for editing and review by multiple team members; 21 CFR Part 11 compliant electronic signature for document approvals; Document Version Control - Check-in/Check-out; Share completed documents directly with the connected eTMF; Full audit trail; Approved templates to create and collaborate on documentation. Request a Demo >
Preparing for a Regulatory Inspection
This document provides a comprehensive overview of how to prepare for regulatory inspections conducted by agencies such as the EMA, MHRA, and FDA.
Trust the Process - TMF Culture
In Season 2, Episode 3 of Trust the Process, hosts Gillian Gittens and Avani Amin welcome Laurel-Ann Schrader, Director of Client Solutions at TransPerfect. Together, they explore how fostering collaboration, ownership, and trust across teams goes beyond just processes.
Now & the Future: Big Data, Wearables, and DCTs
In this on-demand webinar, Trial Interactive experts explore how modern CTMS solutions can be leveraged to account for the nuance that wearable devices and decentralized trials introduce to trial oversight.