Patient Data Reporting Featured Articles

  1. Edgy Observations On Clinical Site Documentation Management: Leading Or Bleeding? 3/6/2018

    For an investigational trial, clinical site documentation encompasses many types of records. These cover every aspect of patient care, policy guidance, and study execution. Not only does the patient medical history and care need to be maintained, but documentation supporting the plan and evidence of execution of a clinical trial must also be managed. This extensive collection of information is always subject to regulatory inspection.

  2. Clinical News Roundup: FDA Awards Funding To Pediatric Clinical Trials 11/10/2017

    Clinical news roundup for the week of November 6th with information on FDA funding pediatric trials, clinical trials for heroin addicts, Marken’s home delivery app, Seeker’s patient enrollment portal, and minority recruitment in trials.

  3. Janssen Takes Clinical Supplies And Patient Data From Paper To Digital 11/9/2017

    Janssen is seeking to replace paper-based conventional processes of managing clinical supplies and tracking patient health data with a new suite of cohesive digital technologies. The new iSTEP (Integrated Smart Trial & Engagement Platform) is a technology toolset developed to automate investigative product supply and data management in clinical studies.

  4. A Critical Juncture For Clinical Trial Data Management 11/2/2017

    Data management functions are managing a much higher volume and diversity of data in response to the increasing scope and demands of global drug development programs. Real-world data and evidence, electronic clinical outcome assessments, data from smartphones and mobile devices, social media community data, and electronic health/medical records are examples of the variety of new data sources now captured during a clinical trial.  The volume and diversity of data presents integration, compatibility, and interoperability challenges that must be optimized to improve drug development performance and efficiency.

  5. Clinical News Roundup: CRS Files Lawsuit Against FDA 10/26/2017

    Clinical News Roundup for the week of October 23, 2017 with information on CRS’ lawsuit against the FDA, FDA boosting patient access to medical devices, the Bracket acquisition of mProve, why Alzheimer’s drugs fail, and more.

  6. Three Ways To Improve Quality In Clinical Trial Processes 10/24/2017

    Timeliness, cost, and quality are all critical factors that must come together to ensure an efficient and successful clinical trial. Unfortunately, the complexity of trials, combined with coordination challenges, force sponsors to have to identify the opportunities needed to improve trials. But how do you know what efforts will produce the best results?

  7. FDA Issues Draft Guidance On Electronic Records 7/24/2017

    The FDA has issued draft guidance for industry titled, “Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers.” The draft guidance provides information to sponsors, IRBs, clinical investigators, and CROs on the use of electronic records and signatures in trials.

  8. Google And Apple Compete For Clinical Trial Supremacy 5/3/2017

    The Apple Watch, along with Apple’s ResearchKit, has already found a home in the clinical space. But it just got some competition. In April 2017, we saw the introduction of the Verily Study Watch. If you don’t know, Verily (formerly Google Life Sciences) is the research organization of Alphabet Inc. devoted to the study of life sciences. According to Verily, the Study Watch is the next step in the company’s targeted efforts to create new tools for unobtrusive biosensing.

  9. Can Better Patient Experiences Lead To Better Medicines? 9/7/2016

    When Thomas Goetz co-founded digital health company Iodine, his goal was to show how the patient experience is not just an optional thing to track but a requirement that sponsor companies must understand in today’s information-rich world of medicine. He is now attempting to turn patient experiences into better medicines by combining data and design to help patients locate the best treatments.

  10. mHealth Panel: Make Progress, Not Excuses 8/30/2016

    I recently moderated a couple panel discussions at the 2016 eyeforpharma Data Quality & Technology in Clinical Trials conference in Philadelphia. One of the panels was on the use of mobile and wearable technologies in clinical studies. While many sponsors continue to cite concerns over regulatory issues, other companies are moving forward with their adoption. But what are the main concerns companies face, and how can they be best overcome?