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Explore our end-to-end capabilities

Get comprehensive phase 1 to phase 4 clinical trial services (planning to reporting). Trust in a proven track record of successful partnering on the design of quality research and delivery of data.

Your success is our success

  • Embarking on a clinical trial with a partner CRO deserves rigorous planning, clear expectations, open communication, tight collaboration, and a high degree of trust. Alimentiv is committed to working together towards achieving your study goals.
  • Optimizing the partnership is essential to realize the maximum value from our relationship. We are skilled in communication and relationship management and apply fit-for-purpose governance and communication strategies to create an effective relationship framework for your studies.
  • When done well, successful partnering achieves greater transparency, deeper commitment, improved quality and increased satisfaction for both parties.
  • Alimentiv’s ‘One Team’ Principle is at the heart of how we work

Excellence

  • Put the interest of patient safety and care above all else
  • Work together effectively as a team by establishing clear roles and responsibilities and high-quality processes
  • Work with a sense of urgency and determined purpose
  • Recognize and give the best of our individual and collective talents
  • Reflect on our progress and accomplishments and openly share learning to
  • Help others succeed

Act with Integrity and Respect

  • “Seek first to understand, then to be understood”
  • Communicate with honesty and respect
  • Make commitments carefully and deliver as promised
  • Look for opportunities to congratulate one another for a job well done and encourage one another when times are difficult
  • Provide timely, truthful, constructive feedback to help each other achieve mutual success
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

We achieve excellence by:

  • Promoting innovation and lifelong learning
  • Acting with integrity and professionalism
  • Demonstrating teamwork, collaboration and leadership
  • Being resilient and adaptive to the changing needs of our business
  • Safeguarding the rights and welfare of the patients in our clinical trials
  • Valuing inclusiveness and diversity

General Capabilities

Providing high quality monitoring services worldwide

We have a well established track record of providing quality monitoring services globally over the last 7 years and are continuing to expand our services into new geographical areas. We have a strong focus on quality and compliance by providing strong oversight of our CRAs.

Monitoring and Site Management

  • We provide global monitoring services.
  • We use experienced GI monitoring experts:
    • Average CRA experience: 10+ years
    • Average number of GI trials monitored: 3+ studies
    • Extensive GI training
    • Low CRA turn-over rate last 2 years

CRA and Site Compliance and Oversight

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

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

Our Team and Partners

Our goal: providing our stake holders (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 additions, 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 collaboration 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 to join our site network, please go to: CONTACT

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, are providing efficient and customised solutions to our clients and are prepared for the future. Any gaps identified are built into improvement initiatives which are driven and lead 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 customised solutions to each protocol and drive virtual trial deployment.

Communication is key.

On average, our writers have more than a decade of medical writing and clinical trial expertise, with nearly two decades of experience for our senior staff. Team members are medical, scientific, biostatistical, epidemiological, and regulatory specialists with diverse technical backgrounds and an array of skill sets, including exceptional project management capabilities. These attributes allow us to take on and guarantee high-quality, on-time delivery of a wide range of therapeutic and content-specific writing projects at all stages of clinical development.

Regulatory and Clinical Writing

Providing fundamental insights and contributions at all phases of clinical development

  • Strategic therapeutic- and indication-specific collaboration from study concept and design to final study report and submission
  • Active and routine engagement and consultation with statistical, medical, and scientific experts
  • Rigorous processes for quality, accuracy, and accountability that assure compliance with current regulatory standards and on-time delivery
  • International Council for Harmonisation (ICH)-compliant templates and ability to use sponsor-specific templates, style guides or standard-operating procedures
  • Expertise integrated as a component of full-service contracts or as stand-alone projects adapted to client needs

Offerings

  • Protocol development and oversight throughout the life of the study
  • Clinical Study Reports (CSRs)
  • Investigator Brochures (IBs)
  • Safety narratives and reports
  • Informed Consent Forms (ICFs)
  • Study charters
  • Clinical and nonclinical summaries
  • Summary clinical development plans
  • Material preparation for advisory board meetings

Scientific Communications and Publication Planning

Interpreting and communicating complex clinical and biological data and concepts

  • Strategic therapeutic- and indication-specific collaboration from project inception to completion
  • Active and routine engagement and consultation with statistical, medical, and scientific experts
  • Interpretation and effective communication of complex data
  • Specific content and/or journal recommendations based on project/client needs and target audience
  • High standards for medical and scientific integrity
  • Rigorous processes for quality, accuracy, accountability, and on-time project delivery
  • Tailored writing services and expertise spanning all stages of clinical development and post-regulatory approval

Offerings

  • Original research articles
  • Systematic reviews and meta-analyses
  • Literature/narrative review articles
  • White papers
  • Conference abstracts, posters and presentations
  • Competitive product research and summaries

Medical Research and Development

Supporting academic research

  • Active and ongoing participation in research related to outcome measure development, consensus processes, investigator-initiated clinical trials and translational medicine initiatives

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Quality is built into our approach from study planning to study reporting

Alimentiv is committed to delivering quality clinical research services in a professional, efficient, timely, and cost-effective manner while protecting patient safety and data integrity for regulatory submissions. We do this using a Quality Management System (QMS) designed to meet applicable global regulatory, technical and organizational requirements, as well as industry standards.

Alimentiv’s QMS is documented in a formal Quality Policy signed by executive leadership, managed by an independent QA function reporting directly to executive leadership, and includes the following:

  • QA responsibility for overall regulatory compliance
  • Regular internal QA audits based on risk
  • Documented control across the end to end clinical trial lifecycle with QA oversight and Management approval for SOPs and Training.
  • 21 CFR Part 11 compliance for applicable computer systems including risk-based Validation according to a controlled SDLC.
  • Procedurally defined study issue resolution and CAPA process to ensure issues are identified, analyzed, resolved, tracked, and closed out, while lessons learned are used for continuous improvement.
  • Documented Business Continuity and Disaster Recovery plans.
  • Regular QA updates to executive management to ensure visibility and resolution of issue trends.
  • Communication with clients, vendors and agencies as needed.

Quality is the responsibility of all staff. Our team of quality assurance professionals have a thorough understanding of our QMS and the services Alimentiv delivers to Sponsors. We mentor study teams to take ownership and build in quality from the start of each project.

Quality by Design is at the heart of Alimentiv’s approach to clinical research. Click here for more info on our implementation of Risk Based Quality Management (RBQM)