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. 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.

  3. 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.

  4. 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.

  5. Special Populations: Renal And Hepatic Impairment Datasheet

    ICON’s experience supporting early phase studies in subjects with renal and hepatic impairment, as well as our close contact with local IRBs, allows our team to expedite study start-up project activities and meet enrollment objectives.

  6. Early-Phase Metabolic Development Datasheet
    ICON’s consultancy services advise on clinical pharmacology study designs based on preclinical data – including potential use of surrogate markers and pharmacodynamic models, validation of those markers and models, clear objective setting and flexible protocol design.
  7. Clinical Pharmacology Datasheet

    The clinical pharmacology team at ICON Development Solutions (ICON) has extensive experience in the design, study conduct and interpretation of clinical pharmacology studies across all major therapeutic areas.

  8. Early Phase Development Datasheet

    ICON Development Solutions specializes in the strategy and delivery of early phase clinical development for informed, timely decision making. With expertise in early phase clinical research, bioanalytical, PK/PD modelling & simulation and the full range of supporting services, we incorporate scientific excellence and product development strategy in all that we do.

  9. 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.

  10. Clinical Temporary Staffing
    SGS’ Life Science Services, part of the SGS group (55,000 employees) has 30 years of experience as a global contract service organization, providing integrated solutions from preclinical activities to Phase I-IV trials, bioanalytical and QC testing.