Seminars and Workshops
Contact us to learn more about hosting a seminar, workshop or day-long program at your location. All presentations are customized for your needs. They include insights and practical advice you won't hear anywhere else. Also, they are reasonably entertaining.
Investigative Sites
Sponsors
Clinical Trial Agreements & Budgets
Informed Consent
International
Management
Working Together
Other
Abstracts
Accelerating the Process of Negotiating Clinical Trial Agreements
CTA and budget negotiation is the most common cause of study delays. Like any other business process, it can be acccelerated with Six Sigma, total quality management, and other management methods. These methods can be applied to other clinical research processes as well.
Best Practices for Investigative Sites
Sharing of "best practices" (highly-effective methods) between investigative sites is haphazard at best. In this interactive workshop, the speaker and attendees will present and discuss their best practices for obtaining and analyzing new studies, recruiting and retaining subjects, obtaining informed consent, communicating with sponsors and IRBs, and other critical study activities.
Breaking the Bottleneck in Clinical Trial Agreements
Clinical trial agreement negotiation has become the most common cause of delay in studies, more common even than subject enrollment. The standard negotiation process actually selects for the least productive and lowest quality sites. Simple contract and process improvements can help both parties accomplish their objectives by saving time, reducing risks, and cutting costs.
Clinical Trial Agreements for Sites
Clinical trial agreements are highly complex documents that help define the parties' working relationship, protect their interests, and comply with numerous regulations. Sponsors naturally write CTA templates from their perspective. Sites then have to negotiate uphill. Learn new perspectives on clinical trial agreements and how to negotiate them effectively.
Clinical Trial Agreements for Sponsors
Clinical trial agreements are highly complex documents that help define the parties' working relationship, protect their interests, and comply with numerous regulations. A poorly crafted template sets the stage for protracted negotiations that will not accomplish these objectives. Even with a good template, negotiating in parallel with multiple sites, each with its own requirements, is a challenging process.
Clinical Trial Budgets for Sites
Well-constructed clinical trial budgets help deliver study results, manage costs, and fairly-compensate and motivate research sites. Sponsors naturally write budget templates from their perspective, usually with a one-size-fits-all philosophy. Learn how to analyze a budget template, craft your response, and communicate why your site deserves more.
Clinical Trial Budgets for Sponsors
Well-constructed clinical trial budgets help deliver study results, manage costs, and fairly-compensate and motivate research sites. Once a budget template is developed, sponsor and site negotiate to find the common ground in an timely manner.
Confucius on Clinical Research
Confucius has a lot to say about clinical research. How important is GCP? "When walking, Yan-t’ai will not take a shortcut." In-person investigator meetings? "Mingle not in projects with men whose ways are not thine." How much information should we put in an informed consent form? "Too far is no better than not far enough." In this session, we will interpret his advice.
Effective Public Speaking Is Not That Hard
From business meetings to industry conferences, clinical research offers many opportunities for public speaking. In this workshop, we will discuss positive attitudes and practical tips for effective public speaking. Exercises will develop persona, style, body language, and power.
Faster, Better, Cheaper: Sponsor/Site Partnerships & Collaboration
Investigative sites determine a substantial part of the cost, time and quality of a clinical trial, and directly influence another substantial part. We can improve quality, reduce costs and shorten timelines simultaneously by following the retail, automotive and other industries into customer/supplier partnerships. For example, 70-80% of site study costs are “hidden,” i.e., off budget, and many of these costs can be eliminated with more efficient sponsor/site business processes. Sponsors and CROs are beginning to create preferred provider relationships; the same principles apply to sponsor/site relationships.
Hiring, Training, Managing and Retaining Study Coordinators
Good study coordinators make successful research sites. How do you hire, train, manage and retain study coordinators to ensure success at your clinical research site?
How to Manage Any Organization
Every organization is different, but the management tools are the same: vision, goals, objectives, reports and meetings. A structured, flexible and efficient management system integrates all personnel into a unified vision to maximize organizational effectiveness while minimizing management overhead.
How to Write Informed Consent Forms
Informed consent forms must communicate important information to the subject within regulatory, IRB, legal and medical constraints. In this workshop, we will review the requirements, discuss how to write clearly, and draft some language.
How [Country] Can Succeed in the Global Marketplace for Clinical Research
The clinical research industry is rapidly globalizing. To succeed in the global marketplace, each country must understand the driving forces, future trends, and how to capitalize on its unique competitive advantages.
Informed Consent, Injury, Insurance and Indemnification: The Four “I”s Every Site and Sponsor Need to Understand
When a clinical research subject is injured, someone needs to pay the cost of treatment. If the subject files a lawsuit, it can cost $1 million for even a successful defense. The right insurance policy, clinical trial agreement, and informed consent language becomes very important. Many investigators have malpractice insurance policies that do not cover clinical research at all, either explicitly or through ambiguous wording. Some potential injury claims are not covered by any insurance. Clinical trial agreements often contain loopholes. Learn about the cross-indemnification “magic bullet.”
Informed Consent Form Development Workshop
Informed consent forms have become so long and complicated that they often defeat their own purpose. In this workshop, we will translate a study protocol into an informed consent form, balancing regulatory compliance, risk management, and understandability. (Laptop computers required for participants.)
Informed Consent Shoot-out
Three experienced study coordinators will each obtain consent from a potential “subject.” See how well they satisfy the letter and spirit of the regulatory requirements, without intimidation. Our panel of judges will critique their performances for style and regulatory compliance. We anticipate a spirited discussion.(8 presenters required)
Is Everybody Happy? How to Work Effectively with CROs
Despite endless criticism from all sides, CROs play a role in over 60% of clinical studies. The simple fact is that many sponsors and sites don’t know how to work effectively with CROs. This session will review many of the common complaints about CROs, explore their underlying causes, and recommend practical solutions.
Misconceptions in Clinical Research
Misconceptions in clinical research start with the protocol and continue through CRO and site selection, budget negotiations, subject recruiting and retention, and data collection and analysis. These misconceptions have significant impact on the success of a study. Learn how to recognize, avoid and mitigate misconceptions to create successful clinical trials.
Money Doesn’t Grow on this Tree Anymore: Developing & Negotiating Successful Clinical Trial Budgets
Clinical trial sponsors and sites are both under tremendous cost pressures. Sponsors must develop efficient study budgets that the best investigators will accept, while balancing the contradiction of high start-up costs vs. pay-for-value. Sites must understand their costs and persuade the sponsor to pay them more than the average site.
Public Speaking as a Way of Life
Public speaking is not as hard as it may seem. In this workshop, we will learn public speaking principles, skills and techniques that apply throughout life.
The Road to Informed Consent: Can We Get There from Here?
Informed consent begins with an initial contact and ends some time after the study is complete. The study subject must acquire, organize and prioritize complex information, while avoiding potential traps such as medical jargon, undue influence, and test anxiety. It’s a long road from reading and discussing the informed consent form, to understanding and applying its contents, to making a decision, and, finally, to being satisfied with that decision at the end of the study. This session will provide a cognitive framework for informed consent and describe some innovative approaches.
Saving Time with Master Clinical Trial Agreements
Master agreements can dramatically streamline the clinical trial agreement negotiation process. However, like most things in life, they have advantages and disadvantages. Learn why, how and when to implement them.
The Secret Code for Efficient Clinical Research
Existing coding systems can be used to improve communication between sponsors and sites and the efficiency of clinical research. For example, physicians use CPT procedure codes and ICD-9 diagnostic codes for clinical reimbursement. Sponsors can use these same codes to unambiguously communicate eligibility criteria and study procedures to investigators. Four new coding systems will be presented, including: Clinical Research Terminology (CRT) codes specify study activities that are not covered by CPT codes. Protocol Deviation & Violation (PDV) codes differentiate between deviations, violations and other errors. These and other coding systems that will be described facilitate the collection and use of metrics. Metrics are the foundation of systematic management and process improvement. “You can’t manage what you can’t measure.” (This session is not about billing third-party payors.)
Sponsor of Choice: Attracting and Motivating the Best Clinical Research Sites
There is a shortage of good research sites. Attract them to your studies and motivate high performance by becoming a "sponsor of choice." Learn how to recruit sites that are likely to perform well and how to work with them to ensure a successful long-term relationship. We will discuss site identification, recruitment, education, contracting and compensation.
Subject Recruiting: The Missing Links
Subject recruiting delays 94% of clinical trials, so perhaps it is time to consider some new approaches. Four new or uncommon strategies can accelerate subject enrollment: investigator self-selection, point-of-care integration, community outreach, and rapid-response metrics.
Twenty Ways to Fix the Clinical Research Industry
Our industry has serious problems. For example: Over 7,000 investigators leave the industry each year. Subject-recruiting problems delay over 90% of clinical trials, with 10-30% of sites enrolling zero subjects. 70-80% of study coordinator time comprises “hidden costs”. Clinical trial agreement negotiations with academic health centers take over three months on average. We will discuss twenty novel cures for what ails the clinical research industry, addressing problems such as investigator and subject recruitment, training and certification, and electronic data capture.
Up Close & Personal: Dissection of a Clinical Trial Agreement
As with most of life, the devil is in the details of clinical trial agreements. We will examine one under a business and legal microscope. If you think you know what you’re signing, think again; it’s ugly in there. CTA negotiation experience preferred but not required.
We Can Get a Lot Smarter about Site Monitoring and Data Cleaning
Clinical research sites can build quality into the data, or site monitors and data managers can try to inspect the errors out. Statistical modeling indicates that competent sites produce quality data at the lowest cost, and that site monitoring and data cleaning produce it at the highest cost. By applying risk-adjusted, adaptive and other management principles to site and data management, study sponsors can slash the cost of clinical research and redirect those resources far more productively. As changes in the pharmaceutical industry force closer attention to efficiency, the role of the site monitor and data manager, as well as relationships between sponsors and research sites, will evolve dramatically over the next ten years.
You Really Want To Be A Principal Investigator?
Clinical research investigators work within a complex legal and regulatory environment. We will discuss investigator responsibility, accountability, delegation of authority, conflicts of interest, fraud, billing risks, and FDA inspections.
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