Category: Software Solutions

The Fit And The Pendulum: Onboarding And Maintaining eClinical Systems and Technology in Clinical Trials

February 2022 | Vincent Puglia

Clinical trial technology is typically a constellation of systems and devices that exists in a continuum with the subject at its center and cocentric rings extending out to sites, partners, providers, CROs, and sponsors. A good clinical trial system (sometimes called “eClinical system”) will enhance efficiency and speed during the clinical trial process, all while keeping subject safety and trial data integrity at the forefront. A system provider and its services should also harmonize with each layer or collective’s current situation and future goals. In this blog series, Vincent Puglia identifies the key factors of vendor fitness and discusses how problems are most likely to occur when there are too many underlying variables.

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The Hidden Stars of Research Pharmacies: Certified Pharmacy Technicians (CPhT)

October 2019 | Richard Malone, MHA

Pharmaceutical clinical trials have no doubt become more complicated over the last several years. Trial design, clinical supply logistics, handling and preparation of study products, as well as related documentation have become increasingly difficult and highly scrutinized. Escalations in demand for strict adherence to storage conditions and chain of custody requirements have become prevalent as well.

Managing even a few trials can be demanding for a research pharmacy. Managing hundreds of trials as take place at many academic medical centers across the country can seem downright impossible. Yet study participants receive life-changing medications daily as a result of the hard work going on behind the scenes. In a previous blog, I attempted to shine a light on the role of pharmacists in the clinical research environment. While pharmacists certainly play an integral role in any investigational drug service (IDS), there is usually an equally important set of certified pharmacy technicians working with them as well. In fact, I guarantee any large, top-notch research pharmacy has a team of all-star pharmacy technicians shouldering an impressive amount of work and responsibility every day.

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The Role of an Investigational Drug Service (IDS) Pharmacist

August 2019 | Richard Malone, PharmD & MHA

I’m now nearly 25 years into my career as a pharmacist and I’ve traveled down a very different path than most of my counterparts. Being a pharmacist serving in roles including Critical Care Clinical Specialist, Pharmacy Director, and Corporate Director of Pharmacy Operations along with a stint as Chief Executive Officer taught me to approach the “What do you do?” conversation more strategically over the years. I suspect pharmacists reading this piece know exactly what I’m talking about.

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Interprofessional Education in Pharmacy Requires Intentional Development & Documentation of Experiential Activities

July 2019 | Richard Malone, PharmD & MHA | Contributing Editor: Denise Klinker, PharmD & MBA

While recently perusing the pharmacy literature, I ran across an interesting commentary on the interprofessional education (IPE) movement in pharmacy training. Before I could finish reading the first introductory paragraph, my mind quickly wandered back to my days as a pharmacy student and resident.

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Slow Acceptance of Technology Adversely Affects Clinical Trial Stakeholders from Sponsors to Patients

July 2019 | Richard Malone, PharmD, MHA

I remember my sense of surprise when I jumped into the clinical research arena full-time several years ago. Having spent over 15 years incorporating cutting edge technology and analytics into my clinical and administrative roles in pharmacy practice, I was relatively shocked by the volumes of paper littered with handwriting of varying degrees of legibility contained in our site study binders.

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