Site Management & Risk-Based Monitoring

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:

• Western Europe, Central Europe, South Africa: FCRA Network Ltd
• Eastern Europe, Baltics: Biomapas
• Asia Pacific: George Clinical

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.