RESEARCH & DEVELOPMENT

Expediting product submissions with quality and accuracy

Regulatory submissions can be a lengthy and costly process when information submitted does not meet requirements, and updates and adjustments are needed to keep drug development on track.

As experienced statisticians and programmers, we work hand-in-hand with your team with end-to-end support to help avoid late-stage delays and expedite your critical regulatory product submissions.

Accurate, efficient and timely data reporting

With stringent guidelines, it can be hard to know if your regulatory data packages are submitted with completeness and in compliance with standards.

Our highly experienced global team of programmers work across all points of data collection and analysis.  From reviewing case report form design to ensuring the final define.xml packages are completed to standards with quality.

We give you confidence in your submission.

Flexibility in solutions

We know you need flexibility. Whether full-service or through a functional service provider (FSP) model, our team of experts can work with you every step of the way and customize efforts based on your needs. Beginning with an in-depth evaluation of current procedures and processes, we can then craft the right mix of expertise, technologies and oversight, as needed, through a flexible FSP model or full-service solution.

Anticipating and addressing end-to-end trial challenges
It’s not always easy to anticipate what roadblocks lie ahead of you on the ever-changing development process.

Our team of statistical programmers have the expertise of dealing with the unexpended challenges throughout a trials lifecycle. We stay connected across our organization to effectively fulfil your programming needs and much more through the right mix of cross-functional expertise, capabilities and collaboration, including:

Biostatistics, Data management, Medical review, Therapeutics, Operations


GRIDDS Overview

Producing Quicker and Quality Evaluations in Safety and Efficacy with Statistical Data Visualization

Manually reviewing numerous data listings line-by-line creates a time, resource and cost issue, causing your team to focus on unnecessary administrative tasks.  We offer deeper visual insights into trial data and patient profiles through GRIDDS, an interactive graphical interface solution that creates a graph-based snapshot view of insights from start to database lock

Quickly Identify Key Criteria & Trends

Graphical displays and images are often faster and easier to relate to, facilitate pattern recognition and enable the review to rapidly identify emerging trends and outliers

Snapshot and Drill Down Displays

High-level displays allow users to quickly grasp the big picture and follow trends, review patients disposition, demographics, monitor compliance, etc. while increasing abilities to review individual patient data

Collaboration

Built-in flexibility allow users to review data in a variety of formats. User-friendly reporting and collaboration capabilities further enable reviewers to track their reviews and query study data in ways that can be shared easily.

Interactive Cross-Lined Reports

Point-and-click drill-down capabilities enable reviewers to quickly and easily home in on specific source data at the patient level, reducing the need to manually review data listings line-be-line.

Data Flexibility

Input Data Flexibility

Ability to use data from various EDC platforms, vendors data and more.

Regular Data Refreshes

Reviewers have access to patient data based on their required refresh cadence dependent on source data availability.

GRIDDS, ensures completeness, accuracy, and consistency, letting you take your time to tackle other critical issues.

IQVIA Statistical Programming

Turn data into a more accurate and insightful resource with IQVIA's statistical programming team.

Technology is enabling RWE breakthroughs

Advances in technology and advanced analytics have long helped other industries. Now it is happening in healthcare.

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