Insights On Clinical Technologies

  1. 3 Questions To Consider During EDC Vendor Selection

    It’s a time of great evolution for clinical research. Recent years have seen a major expansion in the size and scope of industry operations. It’s increasingly common for clinical trials to cross borders, oceans, and continents. Studies and datasets are bigger, and protocols are more complex. All of this makes for a more intricate research environment than previous generations of sponsors and CROs ever imagined. Navigating that intricacy without jeopardizing study timelines is one of the definitive industry challenges today.

  2. Unlock The Value Of Your Clinical Trial Data And Content With Big Data Discovery

    From leisure activities, to our own health and wellness, to the industries in which we work — Big Data has transformed our world. Subscription-based content providers, like Netflix and Amazon Prime, are changing television programming by using detailed customer segmentation and viewing habits to rethink how new programming is funded, produced, and released to the market. Everyday items like Nest are transforming home heating and cooling by collecting and aggregating sensor data to automate thermostat changes.

  3. Defying Industry Assumptions With A Disruptive Approach To Solving Patient Enrollment Challenges

    Most Patient Recruitment Organizations (PROs) have essentially been doing the same thing for many years. Raising awareness of clinical trial opportunities and encouraging enrollment, their basic functions include: trial advertising and marketing communications, site support materials, study websites, and limited metrics tracking.

  4. With Serialization Mandate Looming, Is Your Data Management System Ready?

    In spite of the FDA’s announcement to postpone enforcement until November 2018, all other requirements of the DSCSA remain the same

  5. Precision Medicine In Immuno-Oncology

    The ongoing advances in cancer immunotherapy together with precision medicine may promise a bright future for patients. Learn about the two most common biomarkers in clinical trials that are critical for the drug development process.

  6. Closing the Security Gap In Life Sciences

    The life sciences industry is repeatedly cited as the most at-risk for a major security breach. Many assume that the greatest threat comes from outside: malicious parties that are actively working to compromise company information. While this certainly reflects the new normal in cybersecurity - for example, see Pfizer's recent U.S. Securities and Exchange Commission (SEC) filing acknowledging that their IT systems are subject to frequent attacks – the unfortunate reality is that most information security breaches start with insecure data sharing.

  7. Not Just Tiny Humans: Considerations For Conducting Pediatric Clinical Trials

    When it comes to the conduct of pediatric clinical trials, there are number of things you need to consider in order to ensure the successful conduct of a study. While we can’t predict the outcome, planning ahead for appropriate site conducting clinical studies in pediatric patient populationsand subject selection will take you one step closer. From study design to logistics to recruitment, there are real differences between studies conducted in pediatric populations and studies conducted in adult populations.

  8. Secure Technology For Clinical Trials

    In order to manage study payments a solid accounting protocol should be used — including account receivables and payables as well as cash flow and revenue projections.

  9. Remote Monitoring Versus Risk-Based Monitoring

    Remote monitoring and risk-based monitoring. There has been a lot of confusion recently around these two buzzwords.

  10. 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.