White Papers

  1. Beyond Immune Checkpoint Inhibitors To A New Era Of Personalized Medicine

    Immunotherapies are being touted—both in scientific literature and the general media—as the most promising advances in cancer treatment in decades.

  2. Managing eCOA Data: Principles & Best Practices For Data Managers

    With the quality of data captured throughout a trial playing a crucial role for the success or failure of a study, clinical data management (CDM) is a key element of any research program. During a study lifecycle, data managers will deal with data from many sources such as MRI scans, ECG, lab data, as well as eCOA – all of which are equally important. 

  3. Mobile Apps: A 360° Guide For Clinical Trials

    This paper isolates three specific areas that warrant close attention for app developers, clinical trials sponsors and CROs designing trials powered with mHealth app tools: technology considerations, data considerations and regulatory considerations. These areas are vital to developing a compliant trial that generates meaningful data for clinical development using mHealth sources.

  4. Applying An Innovative Mindset To Post-Approval Research

    Post-approval research studies are becoming increasingly large and complex in the clinical research landscape. These programs are often massive in scope, engaging thousands of physicians and tens of thousands of patients. Unfortunately, post-approval operational strategies have not kept pace with the needs and demands of post-approval (Phase IV) research.

  5. Reducing The Burden Of Data Collection In Oncology Trials

    Understanding patient reported outcomes (PROs) in oncology clinical trials enables researchers to develop more effective treatments for patients battling this illness. But if it isn't easy for patients to report their health data, they won't - so it must be accessible for them.

  6. Patients Prefer eCOA Over Paper COA

    Clinical protocols are increasingly relying on clinical outcome assessments to prove efficacy and safety. COAs are collected electronically for many reasons, and in today’s clinical environment, electronic collection is becoming more common. This document provides scientific evidence and operational proof that patients prefer electronic data collection in clinical trials, while providing a fundamental eCOA education. An objective review of reliable eCOA collection modalities is presented. Several case studies are summarized, providing scientific evidence of patients preferring electronic data collection in clinical trials. A Guide to eCOA and Integrated Medical Devices Selection is also included in this document.

  7. New Paradigms In Alzheimer’s Research: Reviving The Treatment Landscape

    Scientists hypothesize, but cannot definitively prove, that tangles of tau protein and build-ups of beta-amyloid plaque contribute to the hallmark cognitive decline of Alzheimer’s disease. Without a definitive cause or diagnosis – and no cure in sight – many aging adults see no reason to assess their risk, or determine their cognitive status, if little can be done to stave off the disease. Perceptions such as these present a growing challenge to Alzheimer’s research. Understanding these clinical research barriers is critical to developing strategies to overcome them.

  8. Does ICH E6 R2 Effect Risk-Based Monitoring And Overall Quality Risk Management?

    Regulators are encouraging the industry to take a new quality risk management (QRM) approach to clinical trial execution. The latest International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6 R2 guidelines represent the first update to the guidelines in over 19 years.

  9. Maximize The ROI Of Your Post-Approval Research

    If your business is like many other pharmaceutical, biotech or medical device companies, your investments in post-approval research are steadily increasing. Discover how to harness the power of post-approval research to increase data collection, reduce resource burn, save money, and maximize your ROI!

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

    Typically Clinical Research Organisations (CRO’s) involvement in the Clinical Trial process has centered on site management in terms of identifying potential sites and managing patient recruitment.