RESEARCH & DEVELOPMENT

Streamline drug development with innovative Biostatistics

IQVIA Biostatistics can be a competitive advantage when drug development timelines are tight. With our end-to-end data flow and proprietary technologies, and a global presence, we can get you there faster.

Our connected devices streamline data collection while our innovative and complex trial designs   allow for more efficient decision points.

Whether delivered via full-service, functional service provider or staffing, IQVIA is ready to help meet your biostatistics goals.

End-to-end biostatistical support across trials and phases

Do you need a global footprint to reach your trials goals? Or perhaps require experts to orchestrate your regulatory submission? Need specialty expertise to design and analyze your trials? Then our +1,500  biostatistical experts are ready to provide the knowledge and tools to overcome any challenge across any stage of your drug development process.

Our biostats experts provide innovation trial solutions including:

  • Adaptive designs
  • Master protocols (basket, umbrella trials) and bridging studies
  • Combination of real-world data with clinical trial data
  • External comparators
  • Precision dosing

In order to shorten timelines and extract the most value from your data, the right process is imperative. Our biostatistics experts leverage a data-collection framework to support decision making. Let us help you gain the most value from your data.

Karen Zieker
Vice President Biostatistics
IQVIA Data Science Safety Medical

Guide your drug development with our biostatistics expertise and technology

IQVIA supports your trial holistically by applying statistical programming, patient data visualization, and pharmacokinetic expertise supported by proprietary technology.  Along with traditional biostatistics deliverables, we also leverage our knowledge in innovation designs, analysis, machine learning (ML) and technologies to guide you in development.

Innovation in healthcare

Innovation starts with developing proprietary processes, strategies, and software. To ensure you have the best start possible, we use these internally and make them available to you. These biostatistical innovations are powered by our Connected Intelligence ecosystem, combining data, expertise, and advanced analytics to provide you with unique solutions that increase productivity, reduce timelines, and allow for better decision processes. We offer the best fit-for-purpose tech-enabled solution to our customers whereas:

  • Working on our systems and getting full advantage of our data ecosystem with ready-to-use automation tools and connected CDR
  • Bringing innovation in our customers’ systems, with our implementation experts and system agnostic approach that can adapt to any environment with its interoperability

Strategic guidance

Clinical Development Strategies

Overview

As your biostatistics strategic partner, we help you to define a clear pathway to submission, by developing solutions which optimize your timelines, plan trials, estimate time and cost to submission. We study the effects of different options on your development strategy through technology, supported solutions, expertise, and knowledge.

Synopsis Development

With over 30 years of experience designing trials and interacting with regulatory authorities, we support sample size calculations, endpoint capture and analysis, and provide you with the optimal trial design.

Protocol Development

Whether you need biostatistical support to work through market authorizations or the experience and knowledge to effectively navigate regulatory interactions, trust our biostatistics experts to turn your synopsis into a full protocol or provide actionable changes to existing ones and provide support for regulatory interactions.

Trial Execution & Analysis

Whether a review of the database build, authoring the SAP, collaboration with statistical programmers on SDTM and ADaM creation, draft and final deliverables, interpretation of results or clinical study report support, we offer a full scope of biostatistical services and maintain full compliance with all regulatory requirements with strong QA processes.

Regulatory Submissions

Submission time is often hectic. Our experienced team will partner with you to navigate the challenges and support submission activities to the FDA, EMA and PMDA including ISS and ISE.

Our range of submission support services is wide ranging, from CRTs in eCTD format, to Define.xml.  At the same time our team can be your partner from anything as a reviewer guides to provide attendance at regulatory meetings

The right working models for you

Traditional approaches allow you to work with us on each trial independently. We provide you with the flexibility to meet changing needs.

Our Functional service provider (FSP) models provide a dedicated team to support multiple studies and enhance efficiencies as we work within your protocols and standards.

IQVIA seamlessly integrates into your statistical team; this enables you to flexibly expand your team while maintaining control.

Find out more on how we craft a custom-made solution to fit your needs.

Related solution

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