Application Notes & Case Studies

1. 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.

2. 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.

3. Successful Studies With Cloud-Based Clinical Trial-Management Software 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.

4. 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.

5. 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.

6. 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.

7. Rapid And Instructive Building Of Dependable Clinical Studies 7/28/2020

   Southern Star Research needed a technology platform that would allow its data managers to rapidly build and deploy clinical studies without the help of IT staff and programmers. The organization successfully built a comprehensive and ready-to-launch study in four days by partnering with a solutions and services provider.

8. Key To A Faster, More Flexible Clinical Trial Process 7/24/2020

   How a single, integrated data analytics and visualization platform, supported by an experienced partner, can help you move your investigational product to market more quickly.

9. Resting Heart Rate Measurement With Philips Health Band In Adults With Lifestyle-Related Chronic Disease 7/15/2020

   The Philips Health band (PHB) is a wrist-worn wearable device that leverages accelerometry and photoplethysmography (PPG) sensors to deliver sleep, cardiology, respiratory, and energy expenditure (EE) endpoints. In this study the resting heart rate (RHR) was evaluated for clinical relevance in adults with (or at risk) for life-style related chronic disease using the Philips Health band. RHR has been identified as a risk factor and a modifiable treatment outcome.

10. Respiration Rate Measurement With Philips Health Band In Adults With Lifestyle-related Chronic Disease 7/15/2020

    The Philips Health band (PHB) is a wrist-worn wearable device that leverages accelerometry and photoplethysmography (PPG) sensors to deliver sleep, cardiology, respiratory, and energy expenditure (EE) endpoints. In this study the respiration rate was evaluated for accuracy and performance in adults with (or at risk) for life-style related chronic disease using the Philips Health band.