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FEATURED ARTICLES

  • Biopharma Trends That Will Impact The Industry In 2016
    Biopharma Trends That Will Impact The Industry In 2016

    The beginning of the year is always a good time to take a look ahead at the trends most likely to impact the industry in the coming months. One area that is changing quickly, and which promises to impact clinical trials in the coming years, is biopharma. I recently spoke with Jim Esinhart, CEO of Chiltern, about some of these trends, including study protocols, big data, mergers, and new technologies.

  • What You Need To Know About FDA’s Clinical Outcome Assessment Compendium
    What You Need To Know About FDA’s Clinical Outcome Assessment Compendium

    One of the goals of CDER (The FDA’s Center for Drug Evaluation and Research) is to foster patient-focused drug development. As part of that effort, the agency has published a compendium of clinical outcome assessments (COAs) to promote the use of patient-focused outcome measurement in the drug development process.

  • Home Clinical Trial Visits – A Patient Centric Solution
    Home Clinical Trial Visits – A Patient Centric Solution

    The continuing rise of patient-centricity within the drug development industry is a crucial consideration for sponsors when designing their clinical development plans. With initiatives such as the FDAs Patient-Focused Drug Development Program, patient experience and voice within a clinical trial is becoming increasingly important.

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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.

  • Overcoming Adverse Event Challenges To Ensure Subject Safety In An Osteoarthritis Study
    Overcoming Adverse Event Challenges To Ensure Subject Safety In An Osteoarthritis Study

    A double blind, placebo controlled, parallel group, randomized study to evaluate the safety, tolerability, and efficacy of a novel, orally available small molecule for treatment of pain in osteoarthritis (OA).

  • 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.

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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.

Strategic Resourcing Functional Services Strategic Resourcing Functional Services

Our dedicated functional teams have the experience to be your partner in clinical research. We deliver a variety of clinical development services customized to fit your objectives, whether you need a single function across several drug programs, a range of functions within a single therapeutic area, a complete staff lift-out or any other defined need.

Oncology Clinical Trials Oncology Clinical Trials

The unique patient populations, study design challenges, and special endpoints associated with oncology trials demand specialized knowledge.  INC Research/inVentiv Health's Oncology team is uniquely qualified to manage that complexity.

Phase IIb-III Clinical Trials Phase IIb-III Clinical Trials

With decades of experience in clinical trial design, INC Research/inVentiv Health offers a full range of clinical trial services including bioanalysis, biostatistics, data management, feasibility studies, global safety and pharmacovigilance, medical writing, project management, protocol and case report form design, quality assurance, regulatory affairs, risk management, site management, strategic planning, and study monitoring.

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.

Biostatistics Biostatistics

ICON provides biostatistic services for clinical development plans, study design, statistical analyses, and regulatory support.

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