Biostatistics White Papers & Case Studies

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Integrating Trial Data Processes Across Functional Areas Using Electronic Data Capture (EDC) Technology

    One common theme in the pharmaceutical, biotechnology and medical device industry is the constant pressure to accelerate development of drugs, biologics and products to market. By Bill Gluck, PhD, DATATRAK, and Lorraine D. Ellis, MS, MBA, Research Dynamics Consulting Group, Ltd.