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FEATURED ARTICLES

Late-Stage Biostatistics Submission Services: Bridging The Gap In NDA Submissions
Late-Stage Biostatistics Submission Services: Bridging The Gap In NDA Submissions

Many CROs currently offer two categories of services to sponsor companies preparing for an NDA or marketing application submission. The first category contains technical data standards services. By Rob Woolson, Chief Strategist Biostatistics and Data Standards for Regulatory Submissions, Rho

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WHITE PAPERS AND CASE STUDIES

  • SynteractHCR Full-Service CRO Brochure

    SynteractHCR is a multinational clinical research organization, formed from the merger of Synteract with Harrison Clinical Research in 2013, which provides global, full-service clinical trial services. We have more than two decades of experience supporting biopharma companies in all phases of clinical development across multiple therapeutic areas. We customize programs that will deliver timely, high quality data to help you get to decision points faster, taking time and cost out of drug development.

  • Is Your Biobank Ready For The Challenge Of Biomarker-Based Research?

    In this whitepaper we review the key drivers impacting “traditional” biobanking and detail the challenges such biobanks face in delivering new biomarker-based research. To facilitate the discussion of approaches to overcoming these challenges, we introduce the concept of Next Generation Biobanking and define the attributes an “ideal” Next Generation Biobank would need to drive effective biomarker-based research. Finally we demonstrate the benefits of adopting a Next Generation Biobanking approach, with a case study in cancer biomarker discovery. By Mark A Collins Ph.D., BioFortis, Inc.

  • Phase II Primary Insomnia Program In Need Of Full-Service CRO Management

    Clinilabs, a contract research organization (CRO), was selected by an international drug discovery and development company to provide full-service CRO management of a phase II primary insomnia program.

  • ICON Clinical Development Overview

    ICON is one of the world’s largest providers of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialise in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies.

  • Clinical Research Management Phase IIb-IV

     ICON Clinical Research is a division of ICON plc. It specializes in the planning management, execution, and analysis of Phase IIb–IV clinical trials, ranging from small
    studies to complex, multinational projects.

  • ePro Product Suite PHT Corporation was founded in 1994 out of a desire to enable more personalized clinical research. At the time, scientific researchers relying on paper diaries needed a proven way to capture reliable data from patients between clinic visits. PHT patented the model of using handheld devices in conjunction with online technologies in order to send subject self-assessments directly to a central server. These data could then be reviewed in real time for improved subject symptom, compliance, enrollment and safety monitoring. This PHT nvention has become the foundation for the modern electronic patient reported outcome (ePRO) industry.
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SERVICES AND PRODUCTS

Biostatistical Services Biostatistical Services

Delivering high-quality and accurate data analysis, SynteractHCR is a contract research organization that provides robust and customized biostatistical services tailored to your study’s needs. At SynteractHCR, we believe that a statistician is a vital component in the clinical development process. Working as your partner, SynteractHCR’s expert biostatisticians will review your study’s needs and determine the best methods for collecting, analyzing and presenting your data, all in compliance with regulatory guidelines. Our team is trained to provide creative thinking and analysis optimized for your unique study designs. We provide access to your data in a format well-suited to your project requirements.

Outcomes Research Outcomes Research

ICON Late Phase and Outcomes Research deliver strategic expertise, high-impact evidence that explores and demonstrates value of healthcare products and meets the demands of the global and national markets for patient reported outcome services.

Outsourcing Clinical Trials Outsourcing Clinical Trials
SGS delivers temporary staffing for Clinical Trial Services to the Pharmaceutical Industry on National and International level that meets actual project needs with regard to outsourcing of clinical trial specialists.
Late Phase Clinical Biostatistics Late Phase Clinical Biostatistics
SGS’s mission in biostatistics is to offer clinical and statistical expertise from the design of the study protocol, to the data collection tools and all the way up to reviewing the clinical research report.
Late Phase Late Phase
Once a drug candidate is ready to move into later phase clinical trials, the potential for success increases but so do the costs, recruitment hurdles, and logistical challenges.
Biostatistics Biostatistics
SGS’s mission in biostatistics is to offer clinical and statistical expertise from the design of the study protocol, to the data collection tools and all the way up to reviewing the clinical research report.
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NEWS

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