Clinical Monitoring 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. The Fastest Way To Realize The Quality, Cost And Timeline Benefits Of Risk-based Monitoring

    Can a risk-based monitoring (RBM) solution go beyond saving money and actually improve data quality and accelerate treatments to market? Medidata says, “Yes!”

  4. Overcoming Complexity On A Phase 2 Glaucoma Study

    A Phase I/II multi-site study needed to enroll more than 100 patients across three distinct cohorts on an exceeding complex protocol.

  5. Unblinded Monitoring In HCV Trials, A Case For A New Standard

    The goal of current HCV clinical research is to identify new antiviral agents specifically targeting hepatitis C (STAT-C therapies) and to determine how best to individualize treatment regimens in order to optimize outcomes (i.e., increase the SVR rate) and minimize both drug toxicity and the development of resistance. By Cal Astry, PhD; Marion Morrison, MD

  6. Embracing Real-Time Analytics For Proactive Business Management

    In these times of economic uncertainty, companies must adapt quickly to changes in the revenue stream and find ways to stay competitive and profitable, even with substantially reduced staff due to lower revenues. To gain competitive advantage, most companies are digging deeper into their volumes of data and turning to real-time analytics.

  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. Pharma Serialization: Managing The Transformation

    By making the right investments in the right technology with the right business partner, the pharmaceuticals ecosystem can alleviate and hopefully eliminate the threat of counterfeit drugs to patient safety and wellness.

  9. 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.

  10. Improve Accuracy And Efficiency In Data Collection For Mental-Health Evaluations And Assessments

    MedAvante is a global provider of centralized, expert psychological rating services to the pharmaceutical, biotechnology, and medical device industries.