White Papers

  1. Managing eCOA Data: Principles & Best Practices For Data Managers
    4/21/2017

    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. 

  2. Mobile Apps: A 360° Guide For Clinical Trials
    4/7/2017

    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.

  3. Reducing The Burden Of Data Collection In Oncology Trials
    3/3/2017

    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.

  4. Patients Prefer eCOA Over Paper COA
    2/1/2017

    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.

  5. New Paradigms In Alzheimer’s Research: Reviving The Treatment Landscape
    1/19/2017

    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.

  6. CRO’s And The Clinical Supply Chain – It’s Not Just A Label On A Box
    12/20/2016

    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.

  7. Clinical Trials Breathe Life Into Standard Operating Procedures (SOPs)
    12/12/2016

    Standard Operating Procedures (SOPs) have long been fundamental to many industries, and the clinical trials sector is no exception. With the advent of the Good Clinical Practice Guideline in 1996 from the International Conference on Harmonisation (ICH-GCP), stakeholders have been motivated to develop SOPs, not only for regulatory compliance, but also as a routine business practice. Yet, too often, after companies devote significant time and resources into creating SOPs, they may not be followed.

  8. Clinical Study Leader Or Laggard?
    12/12/2016

    Quality management and competitive edge are vital to the clinical trials sector and are fueling widespread use of purpose-built technology. Cloud-based solutions, such as clinical trial management systems (CTMS) and the electronic trial master file (eTMF), are broadly accepted, but these tools fail to address study startup (SSU), a complex set of processes that contribute heavily to lengthy timelines, often lasting seven years. With greater globalization of clinical trials and factors ranging from site selection to regulatory document submission to enrolling the first patient, assessing SSU status is critical. It pinpoints bottlenecks and areas of risk that could impact data quality and derail study budgets and timelines.

  9. Deep Knowledge Of Clinical Study Startup Points Data In Right Direction
    12/12/2016

    Purpose-built SSU solutions track clinical trial operations using much needed standardized performance metrics.

  10. Modern Risk Management In Global Pharmaceutical Logistics
    12/7/2016

    Everything pharmaceutical manufacturers want to know about risk in supply chain logistics but are afraid to ask. What are the rising trends impacting security of product in transport? When and where does risk mitigation become mission critical? And — perhaps the most burdensome — how can I be sure?