MassBioEd Biotech Learning Center: Halloran Shares Insights on New Clinical Trials Courses

We recently announced some new courses being offered by MassBioEd. We thought our readers would be curious to learn a bit more about the courses so we interviewed Halloran Consulting Group who help organize and teach two of the new courses, Managing Clinical Trials (for those with experience) and Clinical Trial Overview (a high-level overview for beginners). Here’s what they shared about who these courses are for, why they are important, and what participants can expect to learn!

Managing Clinical Trials

Thursday Evenings, October 18th – November 29th, 5:30-9pm (No class on November 22nd – Click here for more info & to register.)

Who are the instructors for this course?

Lyn Agostinelli

Tina Forrister

Laurie Halloran

Michelle Hylan

Read bios here.

Why should I take this course?

If you want to be part of a successful trial management team, take this course. Project planning and implementation skills are a “must have” in the current environment of regulatory scrutiny of the Sponsor’s relationship with vendors, cost consciousness, global programs, the use of numerous vendors, and the need to become more efficient and process oriented. Because teams often spend little time together face-to-face, it is imperative to build skills to execute intricate protocols under aggressive timelines and to exacting quality standards.

Who is the target audience for this course? 

Anyone with at least 2 years of experience in a clinical trial role such as clinical operations, safety, regulatory, data management, statistics, etc. or those who completed the “Clinical Trial Overview” course is invited to attend. A certain level of experience or knowledge is required because the course is interactive and hands-on. When all learners have similar baseline knowledge, participants drive the learning rather than simply sitting and listening to a lecturer.

What can I expect to learn?

The course is designed to empower learners to: 1) illustrate the management and oversight process for clinical trials, 2) demonstrate how to encourage and support effective teamwork, 3) apply project planning and start-up skills (e.g., identifying and selecting vendors, defining roles and responsibilities, estimating a schedule, setting clear expectations, planning metrics to measure and control progress and performance, planning for risk, etc.), 4) describe how setting expectations and planning communication supports effective oversight of resources, 5) facilitate the work of the team to execute the project and manage planned vs. actual progress and performance and 6) apply project and vendor management best practices from both the tactical “day-to-day” and strategic “big picture” perspectives.

Clinical Trial Overview: The Players, Process & Language

October 4th & 11th, 5:30-9pm (Click here for more info & to register.)

Who is the instructor for this course? 

Tina Forrister

Read bio here.

Why was this course created?

Life sciences product development is a cross-functional, collaborative activity and the parties involved are highly skilled. However, those who aren’t specifically involved in the clinical arena may know that clinical trials exist but don’t necessarily understand who and what is involved in effectively getting them done. To fill that gap, this course provides a bird’s eye view of what trials are, what they are expected to do, and the standards they must be executed against.

Why should I take this course?

The course will provide context to any life sciences professional about clinical trials and how they fit into the overall business of developing healthcare products. By hearing the story of a clinical trial’s players, its process, and its lingo, professionals taking the course will gather knowledge and perspective they can apply to their current role and to future learning.

Who is the target audience for this class?

The target audience includes anyone interested in the overall, high level picture of clinical trials: what they are, why they are done, the challenges they present, the people involved, and the language and ethics of research. If you’re involved in life sciences and have heard people talk about randomized double blind trials, or read an article about clinical research and want to understand more, join us to learn about how it all really works and the important role clinical trials play in bringing products into the healthcare marketplace.

What can I expect to learn?

The course is designed to empower participants to 1) describe the process of getting a product from discovery, through clinical trials, and to the marketplace; 2) explain the players in the clinical trial process and their roles; 3) define the purpose and objectives for Phase 1-3 clinical trials; 4) list common types and designs of Phase 1-3 clinical trials, as well as the most common terms used; 5) explain the flow of a clinical trial and the most common challenges of each phase; and 6) describe the ethical standards that clinical trials are expected to follow.

Both of these courses qualify for Nursing CEUs under the California Board of Registration in Nursing.

For more information, visit the MassBioEd website or contact julie.deschenes@massbio.org.