At Alimentiv, we foster innovation in Clinical Trials. Our scientific leadership is comprised of thought leaders for GI-related therapeutic areas. Coupled with operational excellence, innovation, and our full-service offering, our team of experts brings depth and perspective to projects and the ability to solve any problem using adaptive planning and a risk-based approach.
Thought Leadership in GI Clinical Trial Design Delivery
Proven Operational Excellence Using Risk-Based Principles
Exceptional Customer Service
Comprehensive Service Offering
At the core of good clinical trial work is, of course, good project management.
Our Clinical Project Directors, Project Managers, Coordinators, and Specialists are experienced professionals trained to deliver superior service to our clients. Their collaborative approach combined with deep therapeutic expertise, and exceptional organizational and interpersonal skills creates a responsive, client-driven framework for success.
Our full suite of imaging modalities includes endoscopy, digital pathology, magnetic resonance, and intestinal ultrasound, each of which can be customized to meet the specific requirements of your trial.
Our team of experts can guide you through the entire imaging process, from trial design and protocol development to study execution and closeout.
Let us help you achieve success in your clinical trial with our innovative and reliable imaging solutions. Contact our business development team today to learn more about how Alimentiv can support your study.
Early feasibility assessment is a complex but valuable process, employing Alimentiv's expert insights (medical, operations, bio stats, regulatory, laboratory) to significantly heighten the reliability of planning decisions for your clinical study.
Alimentiv's multi-disciplinary team of experts provides scientific, statistical and safety assessment of your proposed study and delivers recommendations that improve your protocol and optimize site selection, patient recruitment, patient safety and study timeline decision.
At Alimentiv, we leverage our long-standing global network of top-tier GI investigators to identify, qualify and select the sites that can achieve recruitment goals and deliver high-quality data for your study.
We know what it takes to implement GI studies that deliver quality results. Assessing study risks, optimizing protocol design, selecting the appropriate countries, sites and patient population are key to achieving your project goals. With our experience over the past 34 years, managing more than 150 studies in over 60 countries, Alimentiv is well-positioned to assist in setting your study up for success.
Our Project Managers have extensive experience planning all facets of clinical trials during study start-up activities. Utilizing proven methodologies and existing templates, all planning activities are meticulously tailored to meet Sponsor needs to ensure seamless management of clinical studies.
As part of our innovative Risk Based Quality Management approach, we establish study risks in the early stages of the clinical trial by gathering risk information from cross-functional leads to establish a comprehensive risk registry.
The risk registry is then used to inform trial planning including:
Our holistic approach drives proactive study planning in each functional area of the study team.
Critical risk mitigations are identified by ensuring cross-functional leads and participating in risk identification activities in the early phase of the clinical trial to safeguard the quality of the trial and the safety of the participants.
At Alimentiv, we pride ourselves on our years of IBD as well as our longstanding global relationships with IBD professionals. Using comprehensive recruitment models and templates during start-up and throughout the life of a clinical trial, we leverage our expertise to work with sites on realistic and achievable recruitment plans based on proven strategies that ensure successful recruitment.
At Alimentiv, we employ the use of established recruitment models to serve as the basis of our recruitment strategy. We create recruitment models that deliver by coupling our strategies with customized features based on Sponsor requirements.
A robust project plan is based on comprehensive understanding of study requirements established in the early stages of the study planning phase. Applying our expertise with industry-standard project management methodologies, we work closely with the sponsor to design project plans that meet the unique needs of their study.
Clinical Study Management (CSM) is responsible for the coordination of all activities from all functional groups contracted for a project. They serve as the central portal for communication flow and accountability for the completion of tasks across the project. CSM will coordinate overall study timelines and manage these as the study progresses.
As the primary point of accountability for end-to-end study delivery CSM provides ongoing review and management of project plans and Work Instructions, risk assessments, mitigations, training needs, timelines, contracts and study resources.
We have capable leaders who partner with empowered cross-functional teams to establish clear accountability for assigned tasks.
The risk registry is then used to inform trial planning including:
Our holistic approach drives proactive study planning in each functional area of the study team.
Ongoing monitoring of study activities using a standard suite of tools and systems. Production of ongoing study status reports customized to client needs.
Experienced with all vendor types required to conduct a trial, including IXRS to county-level depots, PRO providers and central laboratories.
Vendor oversight is based on clear service level agreements and Key Performance Indicators.
FAQ documents, medical representation at study meetings, tracking in an e-training system for Alimentiv staff, and managing compliance of all assigned team members to the training plan.
Effective and timely communication is critical to achieving study objectives. We pride ourselves in our ability to build strong, transparent communication channels with our clients, study team, vendors and other stakeholders. We agree to clear guidelines upfront for how the information will be shared, as well as who's responsible for and needs to be looped in on each project communication. Alimentiv provides a commitment to strategic and innovative thinking in partnership with clients for oversight, recruitment strategies, management of risk, and quality.
In-house services or in collaboration with client or vendor, including Investigator Meeting planning & management, vendor and site payments, and provision of study supplies.
Risk Based Quality Management (RBQM) approach to monitoring off-site activity, supported by a Project Management and Monitoring team experienced in IBD.
Measure performance to contract. Management of ongoing tasks, identifying timeline drift, out-of-scope activities, and change order management.
Comprehensive oversight of all functional tasks and their interrelatedness. Ensuring accountability for tasks and timely completion. Measure performance to contract.
Measure performance to contract. Management of ongoing Reviews Managing DMC, DSMB or SSC to deliver key data that enable downstream decisions for clients.
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 TMF Operations team produces a Trial Master File that supports the science behind the study.
We know the TMF is critical in demonstrating subject safety and data integrity throughout the study lifecycle. Alimentiv is a proud partner of Veeva Vault eTMF to deliver top-end active TMF management. Our TMF framework is structured using the guidelines and standards set forth by ICH-GCP and global regulatory agencies and the TMF reference model. We go beyond the basics to ensure your TMF is a cohesive, inspection-ready study package.
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 provide oversight of quality, efficiency, productivity and study deliverables by:
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 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:
Alimentiv ensures global (monitoring) coverage by working and collaborating with local partners who are experts in their geographical area. Our main collaborators are:
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.
We critically evaluate our processes on an ongoing basis. Staff at all levels are involved in the development of process improvement initiatives.
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:
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.
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 trial.
The result is improved trial quality and efficiency, regulatory compliance, and a capability which enables the services today's industry needs.
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.
OPRA Central Monitoring is the leading platform for overseeing quality and practical central or risk-based monitoring in clinical trials.
We are data-driven. Alimentiv's innovative approach to clinical data management is shaped by superior therapeutic expertise and industry experience.
We precisely pair technology and proven processes with clinical studies to streamline the route to more efficient and effective data collection and management. Our study-specific approach begins with a thorough review of specifications, client preferences/history and data planned for collection, paired with tailored recommendations that best serve the needs of study sites and project teams. Our processes to capture, maintain, clean and deliver data are robust, efficient and scalable. We offer a full suite of services utilizing electronic data capture methods.
Alimentiv data services are aimed at ensuring quality, consistency and completeness of the trial data. From form development to data transmission, walk with us, as we bring your trial to life.
Data managers perform regular data reviews to assess the conformity of the collected trial data. The team collaborates with sites, and internal & external stakeholders to quickly address data clarifications and trends.
Alimentiv’s experienced data managers use automated data validation checks (EDC edit checks, and SAS queries) and manual processes to ensure data meets the highest standards for completeness and consistency.
Leverage our suite of standardized reports to gain insights into your study’s progress. We’ll work with you in refining reporting specifications to ensure the format in which your data is presented provides value.
Whether it is utilizing our standard workflows to coordinate with clinical monitoring SDV processes or Imaging R&D Central Reader training, Alimentiv Clinical Data Management has a plan to fit your trial needs.
We make a significant difference. Our expert biostatisticians have a long history of collaboration with clinical researchers and regulatory agencies, and a broad knowledge of all aspects of clinical trials, from the initial design and calculation of sample size requirements to the analysis, display and interpretation of data.
We leverage our vast statistical experience gained through the conduct of academic research and commercial clinical trials to apply innovative statistical methods in a way that speeds up submissions.
We plan the analyses you will need before the study begins and provide reports, statistical summaries, and efficacy and safety analyses promptly and accurately as the study progresses. Our thorough validation and quality control processes eliminate the need for corrections and ensure accurate results. Alimentiv is a CDISC Gold Member with CDISC "Trailblazer" status due to our continues involvement and contributions to new IBD-specific standards. Our unique experience in consulting and operationalizing CDISV/SDTM/ADaM standards for our clients includes data consolidation, migration, and conversion.
At Alimentiv, we have decades of experience applying an innovative methodology to answer clinical questions.
Adaptive trial design is a set of methodologies that can be used to reduce the timelines and costs in clinical trials by allowing modifications to the study design and/or statistical procedures after the study has been initiated, without undermining its validity and integrity.
These methodologies offer potential advantages to the traditional approach in terms of flexibility, efficiency and speed. Alimentiv has experience successfully implementing several adaptive strategies to achieve these efficiencies.
Our biostatisticians have experience designing early phase proof of concept studies, phase I/II PK and PD studies, dose-finding safety and efficacy studies as well as large phase II/III trials. We have also designed and analyzed a wide range of phase IV studies.
We will work with you to define the study objective and select appropriate study endpoints to support the trial hypothesis. Based on the selected endpoints, our biostatisticians will calculate the number of study participants that will need to be enrolled to reject the null hypothesis with an acceptable level of statistical power. Our team can also provide advice about strategies and trade-offs that might be employed to minimize sample size requirements if time or cost considerations exist.
Our biostatisticians will advise you on the best approach to randomization based on your study design and operational considerations:
Our team has experience defining study estimands and putting ICHE9(R1) into practice. We understand the various factors that influence how estimands are developed and can walk you through the various strategies for handling study intercurrent events.
Our statisticians have extensive experience in the GI therapeutic area and can provide stand-alone statistical consulting services to assist you with appropriate trial design, including the development of study estimands, and analytical approaches.
For Alimentiv, CDISC standards compliance starts at data collection and carries throughout the entire data analysis. Our CRFs are designed using CDASH standards which allows for efficient conversion to submission-ready SDTM and ADaM datasets. This shortens timelines for submission and allows for seamless integration of data across clincal programs.
Alimentiv's experienced SDTM team will work with you to smoothly map your data into SDTM domains. Our standard process is as follows:
We offer the flexibility to adhere to whichever version of SDTM fits your needs and the clinical area expertise to give you confidence when it comes time to submit your results.
Our team has experience defining study estimands and putting ICHE9 (R1) into practice. We understand the various factors that influence how estimands are developed and can walk you through the various strategies for handling study intercurrent events. At Alimentiv, our biostatisticians will custom-design your ADaM datasets to fit your analysis and reporting needs. Our standard process is as follows:
Alimentiv is committed to employing the most rigorous and appropriate methodologies in statistical analysis. We employ a wide range of statistical methods ranging from simple two-group comparisons of means or proportions, through survival analysis, multivariable regression models, mixed-effect models, inferential statistics, propensity scores and more.
We have extensive experience developing statistical analysis plans and shells for tables, listings and figures.
Our statisticians play a significant role in protocol and eCRF development to ensure high-quality, consistent, and complete datasets.
Our team will help to define when an interim analysis is appropriate and how it will affect the study design and sample size. Our team can carry out interim analyses on time based on study recruitment milestones, to facilitate decision-making.
Our statisticians play a significant role in protocol and eCRF Alimentiv's biostatistics team will work with the sponsor and project team to:
Alimentiv has SOPs in place to ensure a strong firewall exists between blinded and unblinded staff.
Our experienced statistical programmers offer a variety of services including study-specific reporting, CDSIC conversions, TFLs, and data transfers.
At Alimentiv, we offer a wide variety of standard reports on data quality, statistical monitoring, and study progress but can also work with you to develop customized reports tailored to your study's requirements. For our imaging studies, our standard is to provide data transfers in an SDTM-ready format that can easily be incorporated into your overall SDTM package.
Alimentiv has extensive experience programming tables, figures, and listings to support study reports, interim analyses, Data Monitoring Committee (DMC), and manuscripts. All TFL programming is based on shells developed by our biostatisticians as part of the statistical analysis plan (SAP).
All statistical deliverables from Alimentiv are validated to ensure high-quality and accurate results. Our QC process involves independent double programming and/or code review and/or output review.
Leading the way to timely clinical trial approvals. All projects are supported by Alimentiv's large repository of country submission specifications and requirements.
Our international team of regulatory professionals helps transition multi-national clinical trials from concept to implementation by navigating complex regulatory environments and ensuring quality and timely submissions.
Working cross-functionally with other operational departments, the Regulatory Affairs group provides important regulatory intelligence to the build-out of the ideal start-up strategy for global clinical trials. Complex regulatory environments in North America, Europe and Asia-Pacific are well-understood and effectively navigated to ensure optimal regulatory and ethics approval timelines.
With regulatory intelligence built on insight and experience in over 30 countries in Europe, North America, and Asia-Pacific, Regulatory Affairs at Alimentiv will provide regionally and therapeutically-based considerations to support effective regulatory start-up strategies.
Alimentiv has secured a network of established partnerships across the world to allow for seamless regulatory support and services in a growing number of regions.
Alimentiv Regulatory Affairs leverages a depth of internal therapeutic knowledge to connect drug development with clinical trial submission strategies.
Putting a strategy into motion through effective planning, preparation and execution of multinational clinical trial submissions.
All projects are supported by Alimentiv's large repository of country submission specifications and requirements.
The principles described above are applied to all clinical trial regulatory activities, including:
Regulatory Affairs at Alimentiv will manage and oversee the submission process from protocol completion through end-of-study reporting. This is accomplished through adequate planning and prioritizing sponsor engagement by utilizing tools to ensure transparent and frequent communication and reporting of all regulatory activities throughout the lifecycle of the project. Information flow from the sponsor and other vendors through to the local teams is closely managed to ensure timely and quality submissions.
We apply our depth of knowledge and experience to ensure your study is safe and accurate.
At the heart of our work is the mission to transform human health, while safeguarding the welfare of patients. With more than 30 years of academic, clinical and industry experience, our medical monitors have deep therapeutic knowledge and clinical experience. We provide both strategic and operational advice to sponsors, the sites and project teams throughout the duration of your study.
Providing proactive insight, planning and safety accountability for the duration of the study.
Ensuring protocol adherence to patient eligibility criteria and medical congruency between medical history, concomitant medication and adverse events.
Providing medical support for investigative sites throughout the duration of the study.
Patient Safety is at the core of what we do. Clinical Safety professionals closely support and collaborate on the development and start-up of clinical trials.
Leveraging a depth of medical and technical expertise, Alimentiv manages end to end clinical trial safety processes and effectively supports all activities related to patient safety during a clinical trial.
An integral component of the study team, Clinical Safety professionals closely support and collaborate on the development and start-up of clinical trials.
All clinical trials undergo a thorough and detailed review of the safety processes and procedures that will be followed during the study. Alimentiv adapts its plans and documentation to ensure that the specifications of the protocol align with the regulations and guidelines that apply to the study.
Contribute to the safety components of clinical trial protocols to ensure that safety standards are met. Assist with Risk Management activities.
All stakeholders on a project are informed and trained on the procedures to be followed during the study as it relates to Safety.
End to end safety management for clinical trials.
Facilitating the resolution of safety issues that arise throughout the project lifecycle through timely communication with project teams and sponsors ensuring all stakeholders are promptly informed of safety-related findings.
Review of medical/drug terminologies, consent forms and SAE assessments to confirm that safety-related documents align with project specifications.
Centre to Alimentiv's safety system is the SafetyEasy PV database which provides the required functionality for efficient SAE management and reporting.
Helping to ensure adequate safety oversight during clinical trials and increasing the reliability and pool ability of trial data. Alimentiv's cross-functional team, including Clinical Study Management, Clinical Safety, Medical Monitoring, and Data Sciences, provides the following DMC services.
Clinical Safety and Clinical Data management identify events requiring adjudication for each DSMB meeting.
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.
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