Project Management 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. 10 Insider Tips For eCOA Implementation

    If your organization has yet to adopt the use of eCOA (electronic clinical outcome assessments) in your clinical trials, then this white paper on successfully implementing the use of this technology should be of interest to you.

  3. CROs And The Clinical Supply Chain – It’s Not Just A Label On A Box

    Typically Clinical Research Organizations (CROs) involvement in the clinical trial process has centered on site management in terms of identifying potential sites and managing patient recruitment. They also offer services related to activities such as protocol development, data management, laboratory services, and toxicology analysis amongst others. Managing clinical supplies has always been seen as a backroom activity, one which sponsors tended to keep a firm hold on, perhaps highlighting their importance to the sponsor in terms of meeting First Patient In (FPI) deadlines.

  4. Transformative Technology For Oncology Drug Development

    Oncology is the number one focus of global drug development, accounting for $65 billion in sales worldwide in 2013 and projected to grow 50 percent in the next five years.1 New treatments, new diagnostics and new medical protocols are beginning to unravel some of the scientific basis and pathways of this disease, with measurable impacts on disease progression and quality of life of survivors.

  5. Optimizing Cardiovascular Clinical Trials With Technology

    The extraordinary advances in cardiovascular medicine over the past decades have extended and improved countless lives. Drugs for heart-related disease make up one of the biggest selling areas, with hypertension medications alone expected to reach over $24 billion in global sales in 2015. Real successes in reducing the death rate from myocardial infarction and controlling blood pressure and cholesterol are some of the true successes of modern medicine.

  6. Transforming Clinical Development: Clinical Cloud™

    Medidata is committed to enhancing and streamlining clinical trials from start to finish—beginning with the trial concept and protocol design to conclusion with actionable data.

  7. Bioanalytical Development Services Brochure

    INC Research/inVentiv Health provides high quality bioanalytical services across the entire continuum of drug development. Our significant experience with small and large molecules, peptides, immunochemistry, LC/MS/MS, HRMS, GC/MS/MS and ICP-MS, combined with having one of the largest capacities in the industry, allows us to blend innovative science with effective, validated processes to deliver quality data on time, every time.

  8. Sourcing For Savings Case Study

    To help the client overcome these challenges, INC Research/inVentiv Health formed a strategic partnership with the biopharmaceutical company and took over responsibility for all of its trial-level clinical data management activities in the United States.

  9. Phase I-IIA Clinical Trials Brochure

    At INC Research/inVentiv Health we have the ability to expedite clinical programs and build the foundation for continued development of the product.

  10. Recruiting Patients With Impaired Renal Function Case Study

    According to FDA Draft Guidance published in March 2010, a pharmacokinetic (PK) study should be conducted in patients with impaired renal function when the drug is likely to be used in such patients and when renal impairment is likely to mechanistically alter the PK of the drug and/or its active metabolites.