Practical On-Demand Courses On The Business Aspects of Clinical Trials

ClinBiz Masterclass

Clinical Trial Outsourcing - Request for Proposal (RFP) Process

How to Manage End-to-End Qualification and RFP Process for Clinical Provider Selection

This course will cover the clinical trial outsourcing request for proposal (RFP) process and how to manage end-to-end qualification and RFP process for clinical provider selection. The course content and modules will include a mixture of video, slides, quizzes, helpful course materials and bonus content. The course is self-paced which means you decide when you start, finish and how quickly you go through the content. After completing all course content, you will be able to use what you learned to accomplish the following for your organization:

  • Streamline your existing qualification, selection, and request for proposal (RFP) process for clinical providers
  • Develop a robust qualification, selection, and request for proposal (RFP) process for clinical providers
  • Ensure your current processes are aligned with the latest and most current industry best practices for clinical provider qualification, selection, and the request for proposal (RFP) process

How to Develop a Global Clinical Trial Budget Like a Pro

The Role of Trial Design and Protocol Complexity in the Overall Budget for Clinical Studies.

With drug development costs at an all-time high and a big focus on cost reduction, it is important for clinical trial professionals who are responsible for developing and managing clinical trial budgets to be well-equipped with the necessary knowledge to prepare, defend and manage clinical trial budgets that are accurate and robust.

In this course you will learn the following:

  • The different sub-categories within the overall study budget and the main cost drivers of each
  • How each cost driver impacts your overall study budget
  • What questions to ask during the different stages of clinical study planning
  • The operational, scientific and strategic considerations that impact your study budget
  • Special budget considerations for outsourced studies
  • The hidden costs driven by protocol design and complexity
  • Investigator Grants – Main cost drivers, questions to ask, and best practices for what to include within this major sub-category of your study budget
  • And finally… how to develop a global clinical trial budget like a pro!

The History of Research Ethics and Regulations

We find the origin of the need for research ethics as well, sadly in some of the worse examples in our research history.

By exploring the history of human subject research, we find the origin of the need for research ethics as well, sadly in some of the worse examples in our research history. From this interwoven history emerges the complicated regulatory infrastructure and ethical dynamic that now governs our clinical research environment. This course will provide the backdrop of history to highlight the need for all research personnel to fully understand and conduct research at the highest industry standards for both regulatory and ethical reasons.

In this course you will learn the following:

  • Introduction to Early Research
  • Research’s Worst-Case Scenario
  • Persistent Problems in Research
  • Regulatory Infrastructure
  • Reflection and Your Role in Research

Site Budget Development and Negotiation Strategy for Study Sponsors

Recorded Online Workshop Session

This course is comprised of the recorded online workshop session from the Virtual ClinBiz Summit 2020 focusing on clinical trial agreement negotiations with a special focus on site budget development and negotiation strategy from the study sponsor perspective. The video recording goes into a great level of detail on how site budgets are developed by study sponsors with various on-screen examples. The respective speaker slides are also included. For context, the online workshop session took place on September 15, 2020.

The recorded workshop session covers the following:

  • Overview of clinical trial agreement site budgets and special considerations in site budget development and negotiations for study sponsors
  • Standard of Care (SOC) and Fair Market Value (FMV) in investigator site budgets
  • Discuss common challenges associated with site budget development and negotiations, and ways to significantly improve these

Negotiating Clinical Trial Agreements for Study Sponsors

Recorded Online Workshop Session

This course is comprised of the recorded online workshop session from the Virtual ClinBiz Summit 2020 focusing on clinical trial agreement negotiations with a special focus on the contract language. The respective speaker slides are also included. The recorded workshop session covers the following:

  • Overview of clinical trial agreements and areas of negotiations for study sponsors
  • Discuss common challenges associated with clinical trial agreement negotiations, and ways to significantly improve these
  • Explore different industry templates, initiatives, tools and contract language used by study sponsors, study sites and CROs along with the strengths and weaknesses of each

Clinical Trial Digital Patient Recruitment Strategies

The Latest Digital Patient Recruitment Strategies at Your Fingertips

Patient recruitment was tough in the past but it is changing! It is becoming easier to find the right patients for your study.  If you are wondering why, this is because digital methods have opened up precise targeting allowing you to spend less but still receive more. This is unlike TV or radio advertisements. You only pay for people who view or click on your ad.  This allows you to target more people in less time because nearly everyone has a smartphone and a similarly large part of that group is also on social media channels such as Facebook, Instagram or Twitter.

As a clinical researcher, it’s important for you to start implementing digital patient recruitment methods unless you are fine with losing potential patients in your trials. Many in the industry have already implemented digital patient recruitment strategies which include the use of Google ads, Facebook ads and Twitter ads. In this course you will learn the strategies and methods to take your patient recruitment efforts to the next level.

Clinical Trial Financial Management For Study Sponsors

Recorded Online Workshop Session

This course is comprised of the recorded online workshop session from the Virtual ClinBiz Summit 2020 along with the respective speaker slides. The recorded workshop session covers the following:

  • Discussion on the common challenges associated with budgeting & forecasting for clinical trials, and ways you can significantly improve your budgeting effort
  • The different financial accrual methodologies used by different biopharma companies. Multiple accrual models and the respective pros and cons associated with each model are discussed

ClinBiz Summit 2019 Complete Conference Video Compendium

Recorded Online Workshop Session

Get access to watch all the available sessions and presentations from the ClinBiz Summit 2019. PowerPoint slides and handouts are included where provided by the speaker. The following sessions and presentations are included in this package:

  • Opening Keynote Session – Looking Ahead: The Future of Clinical Business.
  • CRO/Vendor Contracting and Negotiations – Strategies That Drive Success.
  • Standardization and Innovation in Clinical Outsourcing – Panel Discussion.
  • The Seven Wondrous Ways to Immediately Improve Your R&D Financial Accruals Process.
  • Budgeting for Oncology and Rare Diseases – Challenges, Best Practices and Lessons Learned.
  • Strategically Controlling Clinical Trial Costs – Panel Discussion.
  • Global Site Contracting and Budgeting Session
  • Clinical Trial Agreement Negotiation – Strategies That Work for US vs. Rest of World (ROW) – Fireside Chat.
  • The Business Case for Investigator Initiated Studies (IIS) Fair Market Value Process.
  • Understanding Medicare Coverage Analysis – Overview for Study Sponsors.
  • Investigator Site Payments and Fair Market Value – Industry Standardization, Processes and Technology Panel Discussion.

The Seven Wondrous Ways to Immediately Improve Your R&D Financial Accruals

Recorded Online Workshop Session

In this session, Chris Chan, Executive Director of R&D Finance at FibroGen delivers a dynamic presentation on proven ways to immediately improve your R&D financial accruals. The session took place at the ClinBiz Summit 2019.

Global Site Contracting and Budgeting Session

Recorded Online Workshop Session

In this session, Donna Libretti Cooke, Head of Contracts & Budgets\\Study Start-Up and Conduct Specialists\\Global Clinical Trial Services at Bayer U.S. Pharmaceuticals delivers a presentation on pressing topics within global site contracting and site budgeting. The session took place at the ClinBiz Summit 2019.

Understanding Medicare Coverage Analysis - Overview for Study Sponsors

Recorded Online Session

In this session, Kelly Willenberg, President of Kelly Willenberg & Associates delivers a dynamic presentation on medicare coverage analysis for study sponsors. The session took place at the ClinBiz Summit 2019.

Looking Ahead: The Future of Clinical Business

Recorded Online Session

In this session, Brigid Siegel, Head of Procurement, Clinical & Patient Services at Montefiore Health System & Albert Einstein School of Medicine delivers the keynote presentation on the future of clinical business. The session took place at the ClinBiz Summit 2019.

The Business Case for Investigator Initiated Studies (IIS) Fair Market Value Process

Recorded Online Session

In this session, John Moose, Principal at IQVIA delivers a presentation on the fair market value process for Investigator Initiated Studies (IIS). The session took place at the ClinBiz Summit 2019.

Standardization and Innovation in Clinical Outsourcing - Panel Discussion

Recorded Online Session

In this session, a panel of seasoned industry executives from Novartis, ACADIA Pharmaceuticals, Montefiore Health System & Albert Einsteing School of Medicine and Strategikon Pharma deliver a dynamic discussion on the topic of standardization and innovation in clinical outsourcing. The session took place at the ClinBiz Summit 2019.

Budgeting for Oncology and Rare Diseases - Challenges, Best Practices and Lessons Learned

Recorded Online Session

In this session, Victor Lucariello, Senior Manager, Business Analytics at Celgene Corporation delivers a presentation on clinical study budgeting for oncology and rare diseases – best challenges, practices and lessons learned. The session took place at the ClinBiz Summit 2019.

Strategically Controlling Clinical Trial Costs Panel Discussion

Recorded Online Session

In this session, a panel of seasoned industry executives from KPS Life, Endo Pharmaceuticals, Celgene Corporation and RHIEOS-Ventures LTtd deliver a dynamic discussion on innovative ways to strategically control your clinical trial costs. on strategies for successful CRO and vendor contract negotiations. The session took place at the ClinBiz Summit 2019.

Clinical Trial Agreement Negotiation - Strategies That Work for US vs. Rest of World (ROW)

Recorded Online Session

In this fireside chat session, Karla Denney, Head of the Investigator Contracts, Benchmarking and Payments at GlaxoSmithKline Pharma and Caroline Thangavelu, Founder and Owner of ENGAGE Clinical Contracts Solutions address key strategies for clinical trial agreement negotiations from US and Rest of World (ROW) perspectives. The session took place at the ClinBiz Summit 2019.

Investigator Site Payments and Fair Market Value Panel Discussion

Recorded Online Session

In this session, a panel of seasoned industry executives from IACT Health, GSK, Bayer U.S. Pharmaceuticals and Hackensack Meridian Health deliver a dynamic discussion on the topic of investigator site payments and fair market value – industry standardization, processes and technology. The session took place at the ClinBiz Summit 2019.

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