GI Clinical Project Management

GI Clinical Project Management

For Smoother, Faster Trials

With dedicated, GI-experienced study teams serving as a single point of contact from study startup through closeout, our full-service gastrointestinal (GI) clinical trial management brings the momentum, clarity, and steady oversight your complex GI study needs to keep moving.

Exceptional Clinical Trial Project Management Services

Our clinical project management approach integrates site management, imaging coordination, data oversight, and vendor management under one accountable team.

We set the pace, defining roles, decision paths, communication cadence, and change-control plans.

Risks are openly tracked. Issues are addressed before they escalate. Progress and issues are reported the same way every time. We take a proactive approach, and we collaborate as partners with a focus on client needs.

You get:

  • Clear ownership and decision-making
  • Proactive risk and issue management
  • Ongoing communication
  • A partner who works with you — not just beside you

GI sponsors come to Alimentiv for scientific thought leadership, but they stay because of the relationships they make with our team.

  • “

    This study has been managed with impressive quality as a full‑service program, even within a highly challenging and unique environment from both the patient population and procedure/IMP standpoint.”

  • “

    The Alimentiv team, who worked across full service and imaging to support this study, overcame significant challenges to meet and exceed our expectations.”

  • “

    The team’s performance goes a long way in demonstrating Alimentiv’s readiness and reliability as an imaging partner.”

Start Strong With Effective Site Selection Strategies

Successful studies begin with strong foundations. Our startup teams work in parallel across regulatory submissions, site selection, contracting, and training to accelerate timelines without sacrificing quality:

  • Our startup team and site engagement team use historical GI recruitment data, performance metrics, and scenario modeling for site selection
  • Feasibility and site selection is overseen by a project management team and happens in parallel to study planning and broader team training
  • Core operational plans — monitoring, communication, data, safety, vendor, and submission plans — are finalized at kickoff
  • Expectations, decision paths, and responsibilities are clearly defined from day one
  • Well-prepared kickoff meetings bring the whole team together, establishing alignment, ownership, and a shared understanding of success
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Keep Your Study Moving With Confidence

Our GI clinical trial management services offer practical site support and disciplined oversight that reduce delays, prevent rework, and ensure patient safety and data integrity while maintaining efficient operations:

  • Site management and risk-based monitoring, with triggers tied to patient safety and data quality
  • Visit flow, investigational product accountability, and deviation handling are tracked in real time
  • Centralized imaging and central reading services are coordinated with visit schedules to maintain endpoint consistency
  • Vendors are managed to service level agreements (SLAs) and key performance indicators (KPIs); issues are logged and quickly addressed
  • Budget tracking and forecasting ensure financial control with transparent reporting
  • GI-trained clinical research associates (CRAs) provide consistent site engagement throughout the study, supported by therapeutic area specialists

Quality You Can Trust With Data and Safety Oversight

Our integrated teams collaborate closely with clinical data science and clinical safety leads on:

  • Regular data reviews, trend analysis, and missing data follow-up
  • Medical monitoring responses with clear turnarounds to sites
  • Establishing independent safety committees with a clearly defined scope and schedule; coordinating meetings and follow-through on actions
  • Planning interim analyses with our biostatistics for clinical research teams
  • Proactive identification of data quality issues for rapid resolution, maintaining study timelines and data integrity
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Reduce Risk With TMF and Inspection Readiness

We maintain electronic Trial Master File (eTMF) in Veeva Vault, aligned with ICH-GCP and the TMF Reference Model. We also schedule quality control (QC), track findings, and keep files inspection-ready throughout your study’s life cycle.

Closeout Confidently With Thorough Processes

We reconcile the dataset and drug inventory, close outstanding items, and prepare submission packages. We also systematically capture lessons learned and apply them to the next study, while final budget reconciliation and documentation ensure accurate financial closeout and complete study records for regulatory review.

Talk to Alimentiv GI Trial Specialists

Discuss your study requirements with our team to explore how our integrated GI clinical project management approach can make your study exceptional.

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