Application Notes & Case Studies

  1. eRegulatory: A Site's Perspective 9/28/2020

    Coastal Pediatric Research (CPR) was well aware of the eRegulatory trend that was surfacing. Before CPR selected a platform, the team gave some thought to what they wanted an eRegulatory system to contain and/or provide. Learn more about the criteria for their selection and what solution met their criteria.

  2. Home Health Nurse Network Ensures Patient Care Continuity During The COVID-19 Pandemic 9/10/2020

    Due to primary provider office closures, patients were unable to schedule their in-office subcutaneous injections required every six months. The client turned to UBC to design, structure and operationalize a program using our nationwide network of registered nurses, which would transition in-office visits to a supportive and effective in-home setting.

  3. Maintain Compliance With A Direct To Patient Via Site Drug Shipment Strategy 9/2/2020

    Developing a drug shipment strategy to introduce enhanced convenience to patients not only supports retention, but delivers added value to sponsors through improved supply chain continuity and end to end temperature controlled compliance. Download the case study to find out more.

  4. Mitigating COVID-19 Risks In A Complex, Fast-Moving Pain Program 8/19/2020

    A cutting-edge biotech was running a program with three active, concurrent, pain studies across 25 sites and 218 patients, with interim database locks scheduled during the summer of 2020 and final database lock deadlines looming close behind. The COVID-19 pandemic put that all on the line.

  5. A Global Observational Registry Of Adult Patients With Homozygous Familial Hypercholesterolemia (HoFH) 8/5/2020

    Clinical development service provider efficiently and strategically manages a global rare disease registry with rolling start-up, including mandated annual data collection and reporting.

  6. CRO Implements A Successful, Patient-Centric Decentralized Solution For An On-going Clinical Trial During COVID-19 8/3/2020

    A mid-sized biotech company was in the middle of conducting an open-label long-term safety study with 137 active patients across 25 sites in the US and Canada. Then the COVID-19 pandemic hit. Rho developed a customized and decentralized solution for their study that would ensure patient safety and data quality while allowing their study to progress according to FDA guidelines for conducting research during this pandemic.

  7. Successful Studies With A Unified, SaaS Clinical Data Management System 8/3/2020

    A service provider was using an in-house clinical development software solution to set up clinical databases to record and analyze trial data. Modifying or updating the system required personnel with coding and development skills and implementing revisions—amended versions of the clinical database—to trial protocols took time that could interrupt data input and reporting, and slow down trial completion. the IBM Clinical Development solution offered the clear choice for designing and managing a study that included a complicated patient visit schedule, multiple tracks within the study groups, and an open-ended and variable patient participation timeline.

  8. Increasing Efficiency And Expertise With A Powerful Clinical Research Platform 8/3/2020

    A full-service CRO that helps pharmaceutical and biotechnology development firms complete clinical trials and prepare regulatory submissions to the US Food and Drug Administration (FDA) and other regulatory agencies for approval needed an EDC solution that it knew could support a wide variety of studies and study parameters. The IBM® Clinical Development solution armed them with a powerful clinical research platform that provides fully integrated advanced modules, such as medical coding and randomization, that help the organization continue to simplify clinical study processes and increase overall trial efficiency.

  9. High-Quality, Audit-Ready Clinical Research Driven By Digital Data Management 8/3/2020

    A contract research organization (CRO) focused on quality needed to more thoroughly document clinical studies for sponsors, regulatory authorities and other auditors. With a cloud-based, unified IBM® Clinical Development platform, the CRO can now quickly create accurate digital records of every action taken, including granting users access and updating study protocols.

  10. Shortening The Pharmaceutical Development Lifecycle And Reducing Costs 8/3/2020

    A CRO was in search of a data science partner that could potentially shorten the development lifecycle of the drugs the CRO was helping to get to market and do so at a reasonable cost. The IBM Clinical Development solution allowed them to complete their study build faster, which ultimately reduced its average EDC deployment to a 4 – 6-week timeframe.