Why Alimentiv Is The Right Partner For Your Project

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.

Our Service Offering.

Alimentiv offers a comprehensive suite of services for Clinical Trials.

Why Choose Alimentiv?

Thought Leadership in GI Clinical Trial Design Delivery

Proven Operational Excellence Using Risk-Based Principles

Exceptional Customer Service

Comprehensive Service Offering

Clinical Study Management

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.

Feasibility Assessment

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.

Scientific & Safety Review

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.

Efficacy & Safety Assessments, considering standard medical practice, regulatory requirements and marketing objectives:
  • Standard disease-specific efficacy assessments
  • Objective measures such as imaging, histopathology
  • Patient-reported outcomes and quality of life measures
  • Incorporating precision medicine
  • Data Safety Monitoring Recommendations
Eligibility Considerations:
  • Target population
  • Patient safety profile
  • Concomitant disease
  • Previous and concomitant therapies

Site Feasibility, Qualification, and Selection

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.

Examples of some of the services we offer:
  • Preliminary site lists for consideration
  • Feasibility questionnaire development, dissemination, and management
  • Site qualification visits and final selection

Operational Review

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.

Operational Considerations:
  • Disease under treatment - subtype, severity
  • Competing trials at country and site levels
  • Regulatory and country-specific considerations: existing approved treatments, regulatory timelines & requirements
  • Product specifications: route, frequency, site requirements
  • Financial Considerations
  • Vendor qualification, selection, management
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Project Planning

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.

Risk Assessment

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:

  • Early input for protocol development
  • Definition and documentation of mitigation strategies in collaboration with the Sponsor
  • Remote & central monitoring strategies

Our holistic approach drives proactive study planning in each functional area of the study team.

Cross-Functional Expertise

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.

Recruitment Strategy

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.

Customizable Approach

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.

Project Plan Development

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.

Examples of some of our Project Plans:
  • Communications plan (incl. Roles and Responsibility Matrices)
  • Deviation Plan
  • Integrated Strategic Monitoring Plan
  • Data Management Plan
  • Risk Management Plan
  • Regulatory Submissions Plan
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Project Execution and Control

Center of Communication and Coordination

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.

Project Oversight

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:

  • Early input for protocol development
  • Definition and documentation of mitigation strategies in collaboration with the Sponsor
  • Remote & central monitoring strategies

Our holistic approach drives proactive study planning in each functional area of the study team.

Project Tracking

Ongoing monitoring of study activities using a standard suite of tools and systems. Production of ongoing study status reports customized to client needs.

Vendor Management

Experienced with all vendor types required to conduct a trial, including IXRS to county-level depots, PRO providers and central laboratories.

Vendor Assessments

Vendor oversight is based on clear service level agreements and Key Performance Indicators.

Study Training

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.

Project Communication

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.

Ancillary Services

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 Management

Risk Based Quality Management (RBQM) approach to monitoring off-site activity, supported by a Project Management and Monitoring team experienced in IBD.

Contract Management

Measure performance to contract. Management of ongoing tasks, identifying timeline drift, out-of-scope activities, and change order management.

Project Timelines

Comprehensive oversight of all functional tasks and their interrelatedness. Ensuring accountability for tasks and timely completion. Measure performance to contract.

Data Monitoring Committee

Measure performance to contract. Management of ongoing Reviews Managing DMC, DSMB or SSC to deliver key data that enable downstream decisions for clients.

Quality Assurance

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.

Trial Master File Management

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.

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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 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 trial.

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


  1. During the proposal process we perform an early risk-assessment and proved a report to enable better planning
  2. Robust risk-assessment and mitigation plans are operationalized though 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


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.

  • 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.

Clinical Data Management

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.

Database Design and Development

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 Review and Validation

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.

Data Validation Processes

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.

Data Reporting

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.

Collaborative Data Review Workflows

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.

Statistical Design & Analysis

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.

Innovative Approach

At Alimentiv, we have decades of experience applying an innovative methodology to answer clinical questions.

Adaptive (Bayesian) trial design

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.

Phase I - IV experience

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.

Sample Size and Power Calculations

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:

  • Simple randomization
  • Blocked randomization
  • Stratified randomization
  • Adaptive randomization, including minimization
ICH E9 (R1)

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.

Statistical and Methodological Consultation

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.

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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:

  • Simple randomization
  • Annotate the eCRF for SDTM domains
  • Map the data fields to the SDTM domains
  • Develop SDTM specifications
  • Program and validate the SDTM domains
  • Develop define.xml and Study Data Reviewer's Guide (SDRG)
  • Provide quality control throughout the process

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:

  • Map the SDTM to ADaM domains
  • Review the Statistical Analysis Plan (SAP) to determine which derived variables are required for analysis
  • Develop the ADaM specifications
  • Program and validate the ADaM domains
  • Develop define.xml and Analysis Data Reviewer's Guide (ADRG)
  • Provide quality control throughout the process
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Statistical Analysis

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.

Statistical Analysis Plan

We have extensive experience developing statistical analysis plans and shells for tables, listings and figures.

Data Quality

Our statisticians play a significant role in protocol and eCRF development to ensure high-quality, consistent, and complete datasets.

Interim Analyses

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.

Data Monitoring Committee (DMC)

Our statisticians play a significant role in protocol and eCRF Alimentiv's biostatistics team will work with the sponsor and project team to:

  • Develop the DMC Charter and mock DSMB reports
  • Define the stopping rules if required
  • Create and present DSMB reports at meetings (closed session)
  • Manage requests for unblinding, as required

Alimentiv has SOPs in place to ensure a strong firewall exists between blinded and unblinded staff.

Statistical Programming

Our experienced statistical programmers offer a variety of services including study-specific reporting, CDSIC conversions, TFLs, and data transfers.

Reporting 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).

Validation and Quality Control

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.

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Regulatory Affairs

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.

Global Regulatory Strategy

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.

Regulatory Intelligence

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.

Therapeutic Expertise

Alimentiv Regulatory Affairs leverages a depth of internal therapeutic knowledge to connect drug development with clinical trial submission strategies.

Regulatory and Ethics Submissions

Putting a strategy into motion through effective planning, preparation and execution of multinational clinical trial submissions.

Comprehensive Knowledge-base

All projects are supported by Alimentiv's large repository of country submission specifications and requirements.

Maintenance and Reporting

The principles described above are applied to all clinical trial regulatory activities, including:

  • Global Amendments
  • Notifications
  • Annual Reporting
  • End of Trial Notifications

Submission to Approval to Clinical Study Report

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.

Medical Monitoring

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.

Medical Expertise and Oversight

Providing proactive insight, planning and safety accountability for the duration of the study.

  • Protocol review and consulting on patient selection criteria, endpoint determination, feasibility assessment and site selection
  • Medical Monitoring Plan adapted to the study:
    • outlines responsibilities of the Medical Monitor and the communication flow with study stakeholders
    • Alimentiv standard process and template
  • Provide therapeutic/indication training of project team and site personnel
  • Presentation at investigator meetings

Medical Review

Ensuring protocol adherence to patient eligibility criteria and medical congruency between medical history, concomitant medication and adverse events.

  • Medical review of eligibility at study start:
    • At the request of the site - determination of screening/randomization eligibility
  • Medical review of protocol adherence post randomization, as part of routine monitoring activities, including documentation of protocol deviations
  • Medical review of laboratory data:
    • Out of range values
  • Periodic medical data review
    • AE listings
    • Concomitant medications listings
    • Coding
  • Medical input/review of tables, listings, figures
  • Regular Medical review with sponsor representative

Medical Communication

Providing medical support for investigative sites throughout the duration of the study.

  • Consultation with the site investigators on medical questions or issues:
    • Subject eligibility and/or ongoing management
    • Use of concomitant medications
    • Protocol and study algorithms or procedures
    • Study drug/investigational product/device
  • Medical monitor availability:
    • 24/7 for urgent questions that may affect patients' safety and wellbeing
    • Within 24 business hours from receipt for urgent but not safety related questions
    • Within 48 hours for non-urgent questions

Clinical Safety

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.

Patient Safety

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.

Safety Strategy & Study Planning

An integral component of the study team, Clinical Safety professionals closely support and collaborate on the development and start-up of clinical trials.

Safety Management Plan & Other Quality Documents

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.

Protocol Development

Contribute to the safety components of clinical trial protocols to ensure that safety standards are met. Assist with Risk Management activities.

Training & Support

All stakeholders on a project are informed and trained on the procedures to be followed during the study as it relates to Safety.

Safety Oversight

End to end safety management for clinical trials.

Safety Communication

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.

Case Management Capabilities

Review of medical/drug terminologies, consent forms and SAE assessments to confirm that safety-related documents align with project specifications.

Case Processing Workflow
  • Receipt, Book-in & Triage
  • Data Entry
  • Medical Review
  • Narrative Writing
  • Quality Control Review
  • Aggregate Review
  • Regulatory Reporting (SUSARs, DSURs, etc.)

SafetyEasy PV (Database)

Centre to Alimentiv's safety system is the SafetyEasy PV database which provides the required functionality for efficient SAE management and reporting.

  • 21 CFR part 11
  • E2B R2/R3
  • MedDRA & WHODrug Coding
  • Supplemented by Alimentiv's internal work instructions and procedures
  • CIOMS, MedWatch, IND Safety Report
  • XML, E2B R2/R3
  • Line Listings (PSUR, PBRER, DSUR)
  • Summary Tabulations (PSUR, PBRER, DSUR)
  • Signal Detection

SafetyEasy PV (Database)

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.

Data Provision

Clinical Safety and Clinical Data management identify events requiring adjudication for each DSMB meeting.

Per Meeting Activities: Forte
  • Clinical Document Retrieval
  • Patient Dossier Development
  • Identification of Adjudicable Events
  • Planning & Coordination of DMC Meetings
  • Participation in PMC Meetings
  • Post-Meeting Review & Meeting Minutes
  • Communicate DMC Results to Sites

Medical Writing

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

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