White Papers

  1. Rescue Is Not A Dirty Word: 3 Measures To Overcome Operational Failures

    - Every year, tens of thousands of clinical trials are initiated. Every year, thousands of those trials falter, and, if corrective action isn’t taken, some may fail to produce usable data. In this white paper, we want to attempt to characterize the scope of the problem facing the drug development industry, and make a case for early, proactive intervention in faltering clinical trials.

  2. An Overview Of The ICH E6 (R2) Guideline

    While the revisions to the guideline mainly impact sponsors, technology providers and contract research organizations need to be aware of the changes and make adjustments to operational procedures, documentation practices, quality approaches and computerized system functionality.

  3. How Virtual Trials Support Patient-Centricity

    In this digital age, virtual trials may very well become the norm at some point in the future, but there are many questions to answer before this can become a reality. In this white paper, we propose how virtual trials may be able to solve all these issues at once while also providing the added benefit of reducing costs related to study sites.

  4. Operating A Pharmacovigilance Group In A Multicultural Global Environment

    The way an individual interprets language is influenced by many factors, including culture, background, education, training, and personal biases. This article will look at the approaches Drug Safety and Pharmacovigilance teams can take to resolve these issues, allowing the pharmaceutical industry to receive the benefits of operating in a multicultural environment.

  5. The Quintessential Guide To Planning A Successful Clinical Trial

    Clinical trials are complex undertakings, with complex planning required. Success or failure is often determined long before the trial even gets underway. Biorasi’s quintessential guide to clinical trial planning helps program managers and operations directors identify and resolve the sticking points that can risk the timely completion of their clinical trials and programs.

  6. Putting CDISC Standards To Work

    Read how integrating CDISC standards at the very beginning of a clinical trial, research organizations can leverage powerful analysis tools to cut through much of the tedious, time consuming, and expensive manual work typically associated with collecting, cleaning, analyzing, quality controlling, and reporting clinical study data.

  7. What Clinical Teams Should Know About Changing Trial Logistics

    When it comes to clinical supplies, the journey is every bit as important as the destination and the price of failure is high. This paper discusses how supply logistics are changing and contains examples of how Fisher Clinical Services is deploying flexible solutions to ensure secure, efficient and cost-effective passage of clinical supplies.

  8. Data Governance In The Clinical Trial Ecosystem

    For biopharmaceutical sponsors, clinical trial data are both the greatest organizational asset and the greatest challenge. This paper discusses the principles of data governance and how they are used to build a business intelligence framework that advances data quality, acquisition, and integration to deliver actionable information for use across the drug development enterprise.

  9. Addressing Suggestibility As A Psychological Phenomenon In Clinical Trials

    How can researchers identify participants’ overall level of suggestibility and then focus on the minimization of this characteristic to solve the issue of suggestibility in clinical trial?

  10. Genetic Counselors - Helping Researchers Brace For The Silver Tsunami Of CNS Disorders

    Genetic testing is making it easier to identify patients for clinical trials. However, genetic testing in the context of clinical trials raises raise important ethical issues, including ones related to informed consent and disclosure of results. Genetic counselors can play a crucial role in helping sponsors address these operational and ethical issues, making trials more efficient, more patient-centered and, ultimately, more successful.