- Legal

Breakout Sessions I
April 29, 2021 • 0 Comment

Staff Retention Strategies for a New Era

*Human Resources
In an increasingly competitive workforce, site employees are looking for additional benefits beyond just financial. Learn how your site can retain and engage talent for the long run.

FACILITATOR 
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PANELISTS 
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How & Why to Set Up a Regulatory Team

*Regulatory
Does your site need a regulatory department? Understand when your site may need a regulatory department and the evolution of regulatory needs. This session will help you formulate a training program for your site’s regulatory team and effectively manage the transfer of knowledge between a central office and local site operations.

FACILITATOR 
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PANELISTS 
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Contracts & Clauses: What They Really Mean

*Legal
In this session, you’ll get the ABCs and 123s of contracts. You don’t need to have a legal degree to understand a contract and its clauses, but you do need to have the tools and insights to know how to identify the major components of a CTA and how to fulfill contractual obligations. Get all you need to know in this session.

FACILITATOR 
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PANELISTS 
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The First Frontier: Explore Entry Into Phase 1 Trials

*Operations
There are tremendous nuances with phase 1 clinical trials. This session will explore the foundational understanding for breaking into phase 1 clinical trials. Learn how to maintain quality throughout the implementation and execution process and set your site up for success.

FACILITATOR 
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PANELISTS 
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Enabling a Low-Burden DCT Experience: Wins & Losses

*Operations
How can we lessen the burden of decentralized clinical trials (DCTs) on sites and patients? This session will discuss and analyze what we’ve learned from using DCTs over the past several years. Understand how DCT elements affect our patients and determine which DCT tools may be easiest to implement and manage at your site.

FACILITATOR 
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PANELISTS 
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I’ve Tried It All! Recruitment Struggles & Modern Solutions

*Recruitment & Retention
When it seems like you have tried everything with recruitment, what do you do next? How do you address challenges with recruitment in modern times with modern solutions? Learn best practices, trends and innovative ideas for recruitment from sites and industry partners.

FACILITATOR 
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PANELISTS 
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Study Budgets: Back to Basics

*Finance
It’s not about building a better mousetrap, but it is about knowing how to build a better study budget. Join this breakout to understand the costs related to clinical trials and learn how to invoice for your study-related activities. Leave with supporting forms and templates that will strengthen your budget negotiations and your bottom line.

FACILITATOR 
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PANELISTS 
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Survival of the Fittest: Strategizing Business Development

*BD & Relationships
This session will discuss innovative methods to revolutionalize your business practices. Learn how to succeed in creating a successful site that will have you choosing which studies to take. Understand how to utilize collaboration and understand the dynamics that get you picked for that study!

FACILITATOR 
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PANELISTS 
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Breakout Sessions II
April 29, 2021 • 0 Comment

Demystifying the Onboarding Experience

*Human Resources
Your site’s staff onboarding process can make or break a new employee’s success. Identify what types of trainings are needed and when, as well as programs and processes sites have used to successfully onboard staff. Discover strategies to help your new employees work independently as quickly as possible.

FACILITATOR 
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PANELISTS 
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FDA Inspections: How to Prepare

*Regulatory
Are you certain your site is ready for an FDA inspection? This session will include insights from FDA inspectors and sites that have been inspected. Learn what measures they have implemented to ensure you are inspection ready.

FACILITATOR 
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PANELISTS 
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Enabling Patients: Best Practices for Ensuring Patients Participate

*Recruitment
Join us to hear proven best practices to take patients from initial interest to trial enrollment. This session will explore modern stipend practices, patient engagement strategies, and how to align your site’s processes to increase trial awareness and participation.

FACILITATOR 
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PANELISTS 
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How to Build Strong Relationships of Trust

*BD & Relations
Join this panel discussion on how to build strong industry relationships and explore the communication fundamentals. Learn how to develop genuine rapport with contacts for reciprocal alliances.

FACILITATOR 
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PANELIST 
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Site Director Toolkit: Creating Resources to Run a Successful Site

*Operations
What do you need in your toolkit to be a successful and long-term site director? This session will help you interpret gaps in your operations, how to fill those gaps, and tools to deploy at your site to ensure long-term success. Learn how to integrate strong business practices into your site to ensure accountability and profitability.

FACILITATOR 
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PANELISTS 
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Tactics to Improve On-Time Payments

*Finance
Many sites only have three months or less of operating cash. This session will discuss the hurdles that impact delayed payment terms and recognize the downstream implications that can make or break a site’s success. Learn how to improve on-time payments and who is responsible for what in the payment process.

FACILITATOR 
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PANELISTS 
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Uncovering the Hidden Costs of Hybrid Trials & DCTs

*Finance
Join us as experts in the field identify all the different costs associated with hybrid decentralized trials. Understand how hidden costs are affecting your site’s bottom line and how to justify additional budget line items to ensure your costs are covered.

FACILITATOR 
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PANELISTS 
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Diverse Patient Recruitment & Engagement

*Diversity
This case study review of diversity in action will feature a panel discussing examples of success and learnings for patient recruitment and engagement. Review recent case studies as speakers share best practices and pitfalls to avoid for study recruitment

FACILITATOR 
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PANELISTS 
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The Record Retention Burden: Balancing Regulations & Your Agreements

*Legal
Post-study record retention is more challenging for sites than ever before. The expertise needed for today’s record archiving now includes more sophistication in inventory management, electronic document security and preparation for medium degradation and technology obsolescence. Additionally, sites are now seeing increased requirements for record retention from sponsors and CROs. Join us for a session that will explore what the actual regulations for record retention are, what is required to be a long-term record storage vendor and how to set mutually beneficial agreements with sponsors and CROs.

FACILITATOR 
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PANELISTS 
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Breakout Sessions IV
February 21, 2023 • 0 Comment

Risks of DCTs & How to Mitigate Them

*Legal
What CTA clauses do sites need to consider to mitigate risk when participating with DCTs? This session will evaluate potential risks, such as PI oversight, to help you construct a risk mitigation plan for your site.

FACILITATOR 
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PANELISTS 
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Site Optimization to Maximize Profitability

*Finance
With inflation and costs at an all time high, it’s critical to evaluate your site’s fixed costs and identify opportunities to reduce them. This session will share cost-saving methods and how to modify site operations to maximize site efficiency and profitability.

FACILITATOR 
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PANELISTS 
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eRegulatory and eSource: The Pros & Cons

*Operations
As eRegulatory and eSource systems become more common at sites, it is important to understand the differences between electronic and traditional regulatory processes as well as source data collection. This panel will discuss barriers to moving to electronic regulatory and source document platforms and if they are right for your site.

FACILITATOR 
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PANELISTS 
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Understanding Different Site Operation Models: Balancing Relationships & Success for Growth

*Operations
Join us for an open discussion on the pros and cons of site operation models and how they affect relationships with sponsors, CROs, and other sites. How do you differentiate your site so everyone wins? This session will unpack learnings from operating different site models so you can determine the best way to organize your site business.

FACILITATOR 
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PANELIST 
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Privacy, Data & Protection: What You Need to Know

*Regulatory
The need for privacy protection and secure information disclosure for clinical trials is an ongoing challenge. This session will discuss how HIPAA, protected health information (PHI) and personally identifiable information (PII) apply to your site and prepare you for EU privacy regulations that impact sites globally.

FACILITATOR 
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PANELISTS 
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How to Stand Out as a Site & Be Selected for Studies

*BD & Relations
Do you want your site to stand out during feasibility? Come learn from successful sites and sponsors on how to become a partner site of choice. Understand the key elements of the study startup process and get tips and metrics from sponsors and CROs to help improve your site’s visibility.

FACILITATOR 
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PANELISTS 
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The Foundations of Consenting in Modern Times

*Recruitment
What do we need to do to assure our patients continue to be consented in the right way, given the tremendous increase in trial complexity? Join us for an engaging discussion as we compare traditional consenting practices with modern consenting needs. Leave this session understanding the basics of consenting effectively and translating that to compliance.

FACILITATOR 
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PANELISTS 
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Financial Implications of Diversity, Equity & Inclusion Strategy

*Diversity
This hot-topic panel discussion focuses on the financial implications of incorporating diversity into your organization’s strategy. We know that new diversity requirements will come with financial needs and changes at the site level, and this session will discuss what some of those changes are and how we ensure they are addressed.

FACILITATOR 
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PANELISTS 
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