Our goal is to be recognized as a premier provider of clinical monitoring services through operational innovation, therapeutic expertise and an uncompromising focus on quality.

CRA and Site Compliance and Oversight:

We provide oversight of quality, efficiency, productivity and study deliverables by:

  • Regional and CRA oversight through our Clinical Operations Leads.
  • Regular CRA assessment visits
  • Use of RBQM to proactively identify risk, manage risk throughout the study and monitor site/subject-specific risks
  • Use of metrics and analytics to oversee and manage site and CRA performance

Our Team and Partners:

Our goal: provide our stakeholders (i.e., Sponsors, sites) with an experienced and qualified team to deliver high-quality service.

We are proud to have a well-established team of clinical research professionals ranging from junior CRAs to well-experienced Operational and Team Leads. In addition, we have long-standing collaborations with local partners who provided us with excellent local knowledge and expertise.

Our internal Monitoring and Site Management team consists of:

  • CRAs: from junior to senior level responsible for monitoring and day-to-day management of our sites
  • Clinical Operations Lead (COL): responsible for CRA/regional oversight
  • Monitoring Team Leads: Line Managers for our CRAs
  • Managers, Monitoring and Site Management: Line Managers for our COLs and responsible for departmental oversight
Monitoring and Site Management:

Alimentiv ensures global (monitoring) coverage by working and collaborating with local partners who are experts in their geographical area. Our main collaborators are:

Our Site Partners, Site Relationships:
  • As a niche GI CRO, we have well-established and long-term relationships with all the main GI centres in the world.
  • We are currently working with more than 700 sites worldwide.
  • In order to continue to serve our clients and establish new collaborations, we are always looking for new quality investigational sites. If you are interested in joining our site network, please CONTACT our team.

Fostering Continuous Improvement:

A strong focus on Innovation, Growth, and Development for our staff, processes and technology

The monitoring and site management space is evolving rapidly. Within Alimentiv, we critically review the capabilities of our staff, processes and systems on an ongoing basis to ensure we meet the latest requirements, we are providing efficient and customized solutions to our clients and are prepared for the future. Any gaps identified are built into improvement initiatives which are driven and led by staff at different levels.

Staff Development:

We critically evaluate our processes on an ongoing basis. Staff at all levels are involved in the development of process improvement initiatives.

Process Improvement:

We are committed to ensuring the continued further development of our staff into the GI clinical research professionals of the future.

This is done by:

  • CRA development track for junior CRAs
  • Mentorships for all staff
  • Individual Development Plans established for all staff
  • Extensive GI training through conferences, lunch sessions, webinars, online training etc.
Technology Capabilities:

Our monitoring team at Alimentiv is constantly evaluating the technological landscape to determine where solutions can be applied to enhance our clients and sites’ engagement and experience. The monitoring team is building our capabilities to provide customized solutions to each protocol and drive virtual trial deployment.

Risk-Based Quality Management

Our enterprise implementation of risk-based quality management utilizes technology, processes and functional roles designed to deliver a flexible, scalable and repeatable solution for all clinical trials.

The result is improved trial quality and efficiency, regulatory compliance, and a capability that enables the services today’s industry needs.

Overview

  1. During the proposal process, we perform an early risk assessment and produce a report to enable better planning
  2. Robust risk assessment and mitigation plans are operationalized through an Integrated Monitor Plan
  3. The monitoring approach and therefore budget will be driven by the strategic monitoring plan
  4. Contemporaneous data drives decisions during the study
  5. Reports serve as evidence your study was conducted with quality and efficiency

Technology

This web-based, fully validated platform allows end-to-end RBQM for both Alimentiv and our customers. OPRA allows us to integrate with any data sources, to plan, execute, report and collaborate with sites and sponsors.

Alimentiv has selected TRI’s OPRA technology as the foundation of the Forte solution for risk assessment, risk management, planning and central monitoring.

Features

OPRA Central Monitoring is the leading platform for overseeing quality and practical central or risk-based monitoring in clinical trials.

  • It was designed following consultation with the MHRA and FDA and has been built from the ground up to align with ICH E6 (R2).
  • OPRA is cloud-based, fully validated, 21 CFR part 11 compliant and easy to use.
  • Our technology enables companies to demonstrate R2 compliance through the combination of data visualization, statistical modelling, decision-making support, activity management and time-based audit trials.
  • OPRA users also benefit from the ongoing support and RBQM expertise of the TRI team.
Central and risk-based monitoring
OPRA offers full support for both central and risk-based monitoring approaches.
Dynamic user interface
OPRA features a fully dynamic interface, allowing users to get the exact view of the data that they need.
Study and site dashboards
View study data at the level you need to assess and make data-driven decisions.
Source data agnostic
Full, time-stamped audit trail of activities and system changes.
KRI Library
Choose from a library of 20 industry standard, pre-validated indicators or choose your own.
Integrated statistical models
Our KRIs use a range of statistical models which are fully integrated into our data visualizations.
Quality trend analysis
View study data at the site and KRI level to see how actions are impacting quality over time.
Configurable thresholds and weighting
Study data can be rolled back at any time to show visualizations looked at a previous assessment point.
Drill down and data review
Drill down from study to site to patient data and perform data review and root cause analysis.
Historic data review
Roll back data at any time through the UI to see how the data looked and see why decisions were made at this time.
21 CFR Part 11 compliant
OPRA has gone through a full SDLC, is fully validated and is 21 CFR part 11 compliant.
Audit Trail
A complete, searchable audit trail allows a comprehensive view of who did what and when in the system.

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