Written by: Kayla Burrell, MS, CSM

Presentation Overview

On September 12, 2024, the Clinical Research Forum of the PMI Atlanta Chapter hosted the “Strategies for Effective IRT Vendor Management in Clinical Trials” forum event by Gayle Flynn. Ms. Flynn spoke to the audience and shared some key knowledge about best practices for Interactive Response Technology (IRT) vendor management that can help sponsors and study teams achieve their objectives and ensure compliance with regulatory standards. Those best practices are through proper vendor management, project management, communication, risk management, compliance, training, and support.

Ms. Flynn explained that IRT is a system used in clinical trials to manage patient randomization, drug allocation, and inventory tracking. IRT increases efficiency, provides up-to-date patient enrollment information, and helps ensure regulatory requirements adherence. Ms. Flynn broke down the best practices for IRT vendor management as follows:

• Vendor Selection: The importance of the vendor's experience, technical capabilities, regulatory compliance, and support will determine the vendor’s capabilities and ability to tailor solutions to your specific needs.
• Project Management: It establishes clear project timelines and milestones and tracks the progress and performance of the vendor.
• Communication: Establishing and maintaining clear and consistent communication with the vendor and the study team to promptly address any issues or changes.
• Risk management: Properly identify and mitigate potential risks and challenges that may arise during the study and prepare contingency plans.
• Compliance: Ensure that the IRT system meets the industry standards and regulations, such as ICH E-6, ICH E-9, and 21 CFR Part 11, and undergoes rigorous testing and validation.
• Training and support: Provided to the study team and the site staff to help ensure user satisfaction and feedback.

Takeaways

• All it takes is one glitch to cause a quirky issue with IRT to bring an entire clinical study to a halt. That is why it is important to follow best practices and implement effective strategies.
• Additional strategies that have been proven effective in ensuring success with IRT are implementing monitoring and quality control, change management, and post-implementation review measures such as lessons learned and strengthening ongoing relationships.

Next Event

Join us at the next PMI Atlanta Chapter Clinical Research Forum on Thursday, November 14, 2024.

Keynote Presentation: TBD

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Written by: Nelly Eziashi, MBA, PMP

Since 1993, the Farmworker Family Health Program (FWFHP) has transformed farmworker health through collaborations with health clinics, public health districts, Georgia universities, and corporate partners like Philips. Now in its 31st year and housed at Emory University's School of Nursing since 2001, the program has served over 17,000 individuals. The speaker presented highlights of FWFHP’s journey, showcasing its partnerships and innovative healthcare services delivered directly in the fields, camps, and schools, making a lasting impact on farmworker families.

Presentation Overview 

The Farmworker Family Health Program (FWFHP) is an inter-professional collaboration that has addressed the healthcare needs of over 15,000 migrant farmworkers and their families since its inception in 1993. Based in Georgia, the program operates in collaboration with local clinics, farmers, and churches to provide healthcare services during the peak migrant season each summer. Students from university clinical programs also participate, gaining invaluable experience. Services include preventative and episodic care, sliding-scale medications, and health education, with electronic maintenance of patient records continuing year-round.

Originally started at Georgia State University’s School of Nursing, the program moved to Emory University’s Nell Hodgson Woodruff School of Nursing in 2001. Over its 29-year history, the FWFHP has become a key initiative in addressing critical healthcare needs while simultaneously enhancing student education through hands-on training. Each year, it serves over 600 individuals, making a significant impact on Georgia’s migrant farmworker communities.

Takeaways

Effective project management has enabled the FWFHP to improve patient outcomes, make data-driven decisions, and sustain and scale the program for over 31 years.

• FWFHP Life Cycle Summary:
  • Initiation [Jan/Feb]: Define scope and establish Memorandums of Understanding (MOUs).
  • Planning [Jan – June]: Meet with stakeholders, gather supplies, and build the schedule.
  • Execution [June]: Set up, deliver services, and collect data.
  • Monitoring & Controlling: Manage the schedule, monitor weather, and hold daily retrospectives.
    Closing: Complete evaluations, debrief, and generate reports.

• The project management knowledge areas for this program can be summarized as follows:
  • Integration: Managed through resource allocation and status meetings to keep everything aligned.
  • Scope: Driven by the program’s mission statement, ensuring all activities align with core objectives.
  • Time: Timelines are dictated by partnerships, particularly with farmers and community stakeholders.
  • Cost: Costs are shared across stakeholders but present challenges due to funding limitations.
  • Quality: Ensured through continuous quality improvement (QI) initiatives.
  • Human Resources: Focused on team advocacy to support both staff and participants.
  • Communications: Leveraged tools like GroupMe, whiteboards, team meetings, and Google Drive for collaboration.
  • Risk Management: Includes standard operating procedures (SOPs), COVID-19 evaluations, safety huddles, and hotel rooming arrangements.
    Procurement: Involves working with community and corporate partners, along with donors, to acquire necessary resources.
  • Stakeholder Management: Collaborates with school districts and local farms to ensure stakeholder needs are met.

Next Event

Join us at the next PMI Atlanta 3rd Annual Special Interest Forums Joint Open House! “Project Management and Beyond 2.0 – A Peek Into The Future” on Tuesday, October 15, 2024

Panel Discussion Topics: Skills Development, Resume Review, the Impact of AI, and DEIAB (Diversity, Equity, Inclusion, Accessibility, and Belonging)

Register at www.pmiatlanta.org/events/event-calendar 

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Written by: Mike Ososki, PMP

Presentation Overview 

At the forefront of business transformation and growth for the State of Georgia, we have the Georgia Center of Innovation, where Asante Bradford is a major player. His extensive background in Creative Media brings technical industry expertise to foster research collaborations and form strategic business partnerships, enabling the entertainment industries in Georgia to connect, compete, and thrive. Asante also educates prospects about the Georgia Entertainment Industry Incentives Act to support, promote and grow our industry here.

Takeaways

Our Georgia entertainment industry is alive and well! may be Asante’s primary message. Between media, film, TV, radio, theater, music, sports, fine arts, and especially the monetary
juggernaut of digital gaming, we have all of it well-covered.

• Film production: Georgia is #1 among all US states
• Video gaming is now a $200B+ industry worldwide—larger than film, TV and music combined, and we have our fair share of talent making this happen.
• The Creative Economy will only grow. Earlier in his career, Asante fought to advance acceptance of YouTube and streaming. Now it’s VR, AR, AI, 6G, Web3, and blockchain. He’s striving to achieve more K-12 education and seed investment to fund projects, so we can continue staying ahead of the curve.
• Education is needed to help creative professionals know how to pitch better. “Anything you can create to make money.”
• All entertainment-related industries continue to converge and integrate more.
• Pair up gifted, motivated students with savvy corporations to create social media and intellectual property that create generational wealth.
• Hot career paths that quickly pay well: “prompt engineering” for AI, and Unreal Engine for 3D graphics.
• We can’t live in fear. You must push boundaries to welcome and embrace new tech, or you’re gone. AI will never replace human creativity, which nothing

Next Event

Join us at the next PMI Atlanta Entertainment Forum on Thursday, November 21, 2024

Register at www.pmiatlanta.org/events/event-calendar   

Written by: Nelly Eziashi, MBA, PMP

Two key approaches stand out in the world of project management: proactive and reactive projects. Proactive projects follow a well-planned path from the start, aiming for clear, anticipated goals. Reactive projects, however, arise suddenly, often addressing urgent needs or crises. Though both methods can succeed, reactive projects bring unique challenges, including heightened stress and increased risk of failure.

Presentation Overview 

Not all projects enjoy the luxury of stability and ample planning time. Sometimes, immediate action is needed, and plans must change on the fly. In this discussion, the audience received some practical tips and tricks for handling high-stakes, time-sensitive scenarios. Insights were shared on prioritizing tasks, identifying risks, and communicating effectively. Below are some of those learning:

• Staying Vigilant and Prepared:
  • A Project Manager must stay alert, anticipating potential issues. Look out for early warning signs: persistent complaints, rumors, high turnover, or resistance to change. Recognizing these signs can save a project from missing its deadline.
• Containing the Crisis:
  • When a crisis hits, identify the cause quickly. Understand what happened, its full impact, and possible consequences. Your goal is to contain the crisis swiftly. Get accurate information, assess the damage, and determine if it might spread. If preventing a crisis isn’t possible, containing it is critical.
• Acting Quickly and Decisively:
  • After identifying the crisis, act fast and decisively. Communicate clearly at all levels of the organization. Transparency and speed are key to minimizing the crisis’s impact and steering the project back on course.

Successfully handling a crisis can boost your career. After a crisis, document "lessons learned" and recommendations. Thorough post-crisis analysis is vital for improving future crisis responses. Examples of types of business crises:

• The Fire Drill: Sudden issues requiring immediate action
• The Grenade: Explosive problems with wide-reaching impact
• The Black Swan: Rare, unpredictable events with severe consequences

Takeaways

• Face Reality: Acknowledge, communicate urgency and take charge
• Make Quick Decisions: Act swiftly and thoughtfully, but skip deep analysis
• Drive Actions: Track progress and flag risks and delays
• Team Communication: Coordinate and adapt tasks; update stakeholders accurately

Next Event

Join us at the next PMI Atlanta Healthcare Forum on Wednesday, September 18, 2024

Keynote Presentation: "Project Management with a Clinical-Academic-Community-Corporate Partnership" by Erin Ferranti

Register at www.pmiatlanta.org/events/event-calendar

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Written by: Alex Leonard, PMP

Presentation Overview 

On May 21, 2024, the PMI Atlanta Chapter met at Motion Recruitment in Dunwoody, GA. To kick off this live and engaging event, the PMI ATL Agile Forum Program Manager provided an overview of project management methodologies and common frameworks. This was a perfect segway for our guest, Diamond Walker, to walk the audience through her unique project case study. She discussed the challenges she experienced while managing a New Web-Based Application project.

Ms. Walker described the scope of the project, and how she and her team navigated stakeholder change resistance and low engagement, constantly changing requirements, heavily skewed timelines, and limited resources. Diamond reviewed the relevant factors pertaining to the background of the project and how things evolved amidst the challenges. She provided the audience with advice on approaches to employ if they are faced with similar challenges.

Some of the recommendations provided included:

• Analyzing each stakeholder’s communication style, to know how to best address and respond to concerns
• Implementing team-building activities to foster cohesion when team morale is at risk due to adverse stakeholder influence/behavior
• Communicating openly and frequently when faced with conflict
• Being proactive and providing solutions or alternatives to address concerns
• Seeking mediation or neutral third-party facilitation to assist with resolving conflict
• Prioritizing tasks when faced with limited resources and changing requirements
• Leveraging technology to optimize resource utilization
• Eliminating inefficiencies to streamline processes and improve project efficiency

When bringing key stakeholders up to speed in an environment of constantly changing requirements, many stakeholders on Diamond’s project had competing interests. In this type of situation, a Project Manager must negotiate with stakeholders in a way that encourages their buy-in without introducing scope-creep or sacrificing other elements of the project like requirements, timelines or resources.

Takeaways

• Do not take things personal and make every effort to understand your stakeholders
• Gird your loins and keep all lines of communication open and document efforts taken to resolve conflict
• A Win is a Win and celebrate all team accomplishments, no matter how small
• Understand your “Why” and keep team morale high and remind them of the benefits to a successful project outcome

Next Event

Join us at the next PMI Atlanta Agile Forum on Tuesday, August 20, 2024

Register at www.pmiatlanta.org/events/event-calendar 

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