Events

Conferences

February 7-8, 2018

Investigator Initiated Sponsored Research (IISR) 2018
Boston, MA

CBI’s IISR 2018 — Investigator Initiated Sponsored Research is the only annual event dedicated exclusively to helping you and your organization improve your IISR Programs by providing innovative and forward-thinking approaches to support collaborative partnerships, promote proactive contracting, financial planning and integrate best practices in clinical operations for medical affairs excellence in the global expansion of clinical trials. Now in its 6th year, CBI’s IISR Summit charges forth into 2018 with new collaborative workshops, partner-driven panel discussions and SOP information deep-dive session for all your need-to-know best practices and technical solutions for managing your rapidly evolving IIT portfolio.

For details and registration, .https://www.cbinet.com//conference-registration

February 13-18th, 2018

SCOPE Summit for Clinical Ops Executives 2018
Orlando, FL

The 9th Annual SCOPE Summit, taking place February 13-15, 2018 in Orlando, FL, will offer three stimulating days of in-depth discussions in 18 different conferences, 3 plenary keynote sessions, and the ever-popular interactive breakout discussions focused on advances and innovative solutions in all aspects of clinical trial planning, management and operations: Site Selection and Management, Patient Engagement, Recruitment and Retention, Protocol Optimization, Feasibility, Data Strategy & Analytics, Sensors and Wearables, Project Management, Outsourcing, Forecasting, Resource Management and Capacity Planning, Budgeting and Contracting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Post-Marketing Studies, Observational Research, Clinical Supply Chain, and Precision Medicine.

For details and registration, .http://www.scopesummit.com

April 4-5, 2018

Let’s improve clinical trials today!
Gaylord National Resort and Conference Center, Maryland

Join industry leaders from pharma, biotech, clinical research organizations, health care organizations, and advocacy groups to advance patient and physician participation in clinical trials. The forum will discuss how we can bridge people and processes, technology and regulations. Become a sponsor!

Register Now.www.bridgingclinical.com

Training Programs

December 12-13, 2017

Clinical Project Management: Introduction to Practical Clinical Trial Planning for Project Managers
Philadelphia, PA

This course is an introduction to clinical project management in the pharmaceutical industry. The focus is on individuals who want to learn basic project management skills and how they can be applied to the drug development process, especially in the management of clinical trials. The needs of relatively new project managers who are not familiar, or experienced, with specific technical tasks involved in clinical trial management are addressed. There is specific focus on the need to anticipate, understand, and implement detailed project management activities in a proactive manner. This course includes discussion of a highly detailed and fully developed clinical trial management process map. Discussions of the process map are practically oriented with emphasis given to useful advice that, when implemented, will assist with trial management

December 12-14, 2017

Monitoring Clinical Drug Studies: Beginner
Boston, MA

This fundamental “how to” and “why” workshop focuses on current regulatory requirements to promote successful monitoring of studies. Participants will learn about the role and responsibilities of the monitor, the investigator, and the IRB from pre-study through post study. Best practice techniques for site management will be provided, and activities such as case scenarios and simulation exercises reviewing an informed consent document, investigator study file, subject case report forms, and source documents will reinforce learning concepts. This is a practical, hands-on introduction to the job and how clinical monitoring tasks are performed.

December 12-13, 2017

Preparing IND Submissions: How to Organize, Write, Submit, and Track Submissions
San Francisco, CA

The Regulatory Department is the key contact with regulatory agencies. Regulatory must prepare documents that inform the Agency about the proposed development plan, keep the Agency up to date and answer any questions the Agency has about an on-going investigation, request and prepare for meetings with the Agency to discuss development plans, construct and write the marketing application and submit any updates to the marketing application in a concise and informative manner.

December 19-20, 2017

Monitoring Clinical Drug Studies: Intermediate
Boston, MA

This course reflects current industry trends and challenges for the more experienced monitor/clinical research associate – with a focus on developing tools and identifying challenges for effective monitoring. Industry standards and best practices will be discussed with an emphasis on the relationship between the Sponsor/CRO and the Investigator/site personnel. References and resources (including those available online) will be provided. Topics include site management, developing tools for effective monitoring, comonitoring assessments, challenges in our global environment, and successful time management. Discussion will include how sponsors/CROs interpret and implement various aspects of clinical trials and GCP principles.

Take advantage of our $1,675.00 price by registering early!* After November 17, costs are $1,875.00.

January 23-24, 2018

Monitoring Clinical Drug Studies: Advanced
San Diego, CA

This course will focus on more complex and challenging issues affecting the Clinical Research Associate with management/leadership responsibilities. Current hot topics and trends will be discussed. Participants will analyze case studies to identify how monitors/study leaders could have identified, managed, and followed up on under performance or non- compliance issues. Corrective and preventive action plans (CAPA) will be developed as part of the course activities. Training and mentoring techniques will be included to assist training/mentoring sponsor/CRO and site staff.

January 24-25, 2018

Conducting Clinical Trials Under ICH GCP E6
San Diego, CA

This course provides a comprehensive review of Good Clinical Practice (GCP) and FDA regulations and requirements. Participants receive a foundation of knowledge about GCP, practical examples, and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring and preparation of protocols, consent forms, and investigator brochure. Information on maintaining an ongoing relationship with the FDA will also be discussed. This course enables clinical professionals to prepare concise documents and provide their company and the FDA with necessary information for the clinical studies.

February 5-7, 2018

Monitoring Clinical Drug Studies: Beginner
Philadelphia, PA

This fundamental “how to” and “why” workshop focuses on current regulatory requirements to promote successful monitoring of studies. Participants will learn about the role and responsibilities of the monitor, the investigator, and the IRB from pre-study through post study. Best practice techniques for site management will be provided, and activities such as case scenarios and simulation exercises reviewing an informed consent document, investigator study file, subject case report forms, and source documents will reinforce learning concepts. This is a practical, hands-on introduction to the job and how clinical monitoring tasks are performed.

Take advantage of our $1,795.00 price by registering early!* After January 4, costs are $1,995.00.

February 6-7, 2018

Adverse Events: Managing and Reporting for Medical Devices
Philadelphia, PA

This course provides a detailed and thorough introduction of FDA regulations for newcomers in the field of medical device safety: a comprehensive overview of the requirements, current approaches for professionals in the research and post-marketing areas, an overview of the emerging field of devices that deliver drugs or biologics, and an opportunity to discuss the challenges facing those reporting and managing adverse events in the medical device industry.

Take advantage of our $1,675.00 price by registering early!* After January 4, costs are $1,875.00.

February 13-14, 2018

Soft Skills Development for Clinical Research Professionals
Boston, MA

In an environment that is ever-changing with organizational mergers, role revisions, and an emphasis on risk-based oversight approaches, the need for better communication skills and comfort with change is essential. The focus of this course is to enhance communication skills and support personal development while building stronger team relationships in clinical research settings. This course is designed to demonstrate and reinforce techniques such as prioritization, greater effectiveness, flexibility to support work-life balance, communication, and focusing on becoming leaders in our individual areas. Self-evaluation and consideration of “why” we react to things the way we do and how we can implement change will be addressed through various activities. These skills are valuable in addressing many of the everyday stresses faced by those in the clinical research industry.

Take advantage of our $1,675.00 price by registering early!* After January 4, costs are $1,875.00.

February 20-21, 2018

Good Clinical Practice Regulatory Changes, Trends, and Best Practices Implementation
San Diego, CA

This course will review recent FDA guidance documents and general regulatory trends, including revisions to ICH GCP E6 R2 and the repeal of the EU Clinical Trial Directive with replacement with the EU Clinical Trial Regulation 536/2014. With a number of new FDA guidances released over the past several years related to investigator oversight, risk-based monitoring, electronic medical records, and electronic informed consent, the industry must consider the trends and what the regulatory agencies are focusing on. We are seeing revisions in the U.S. and EU related to risk management and oversight that sponsors and sites should be prepared to implement with best practices. With the availability of multiple electronic resources there is an expectation to review information in real time; however, we still need to consider resources, confidentiality, and applications in a global research environment. In this session we will discuss recent trends, upcoming changes and how to design best practices in an evolving clinical research world.

February 20-21, 2018

Monitoring Clinical Drug Studies: Intermediate
Philadelphia, PA

This course reflects current industry trends and challenges for the more experienced monitor/clinical research associate – with a focus on developing tools and identifying challenges for effective monitoring. Industry standards and best practices will be discussed with an emphasis on the relationship between the Sponsor/CRO and the Investigator/site personnel. References and resources (including those available online) will be provided. Topics include site management, developing tools for effective monitoring, comonitoring assessments, challenges in our global environment, and successful time management. Discussion will include how sponsors/CROs interpret and implement various aspects of clinical trials and GCP principles.

Take advantage of our $1,675.00 price by registering early!* After January 19, costs are $1,875.00.

February 26-27, 2018

Advanced Good Clinical Practice: Practical Application and Implementation
Philadelphia, PA

This course provides an advanced, in-depth review of the structural elements of Good Clinical Practice (GCP). Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to how quality systems, or a lack thereof, impact overall data quality and regulatory risk. This program is designed for professionals with at least two years of experience in the clinical research industry.

Take advantage of our $1,675.00 price by registering early!* After January 25, costs are $1,875.00.

Webinars

December 12, 2017

Barnett International

Monitoring Reports: 10 Rules of Effective Report Writing

8:30 AM - 11:30 AM Eastern

The Clinical Research Associate (CRA) creates reports that have many audiences, one being regulatory authorities reviewing essential documentation of clinical trials linked to marketing application approvals. This web seminar presents 10 categories of scientific report writing in the context of the role of the CRA and the reports that they write. The applicable reports are monitoring visit reports, e-mails, telephone reports, Memos to File, and more. The concepts of writing in a scientific voice versus first person, objective versus subjective, and many more are presented. This course is invaluable for the CRA, as well as the individual who critiques the various reports.

December 13, 2017

Barnett International

Introduction to Statistics for Non-Statisticians

12:00 PM - 3:00 PM Eastern

This web seminar is intended for clinical research professionals who have little or no background in statistics. In it, we will cover the basic statistical concepts needed to understand the roles statistics play in health research. The topics addressed include types of variables, levels of measurement, descriptive statistics, precision, confidence intervals, and an introduction to hypothesis testing. This web seminar is beneficial to all clinical research professionals involved in the design, monitoring, interpretation, and reporting of clinical trials. Emphasis will be placed on understanding statistical information and not on calculations or statistical formulae.

December 14, 2017

FDAnews

Global Regulation Under Gottlieb-Trump and a Look Ahead

1:30 p.m. - 3:00 p.m. EST

A year into the Trump administration, there’s a lot you know by now — and a lot more you still don’t ...Will Scott Gottlieb’s FDA push to modernize Hatch-Waxman rules on generic approvals? What is the extent of FDA “untapped authority” to increase Rx-vs.-generic competition? What about expedited ANDA review? The agency has not received ANDAs for some 10% of brand-name drugs with expiring patent and exclusivity protections. The four new draft guidances are the work of a tight-knit team of senior staffers hand-picked by Comr. Gottlieb. Which Gottlieb brain-trusters are calling the shots? Most important of all: Will you benefit from Gottlieb’s moves ... or vice versa?

December 14, 2017

Barnett International

Case Narrative Writing for Reporting Adverse Events

1:00 PM - 2:30 PM Eastern

A narrative is a short document that is required by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to briefly describe the events in the life of a patient. These narratives are required when a patient enrolled in a study, after taking the study medication or approved drugs (post-marketing), has discontinued the study because of an adverse event, had one or more serious adverse events, or died. FDA, EMA, and International Conference on Harmonization (ICH) guidance documents call for the submission of a study subject’s experience in narrative form for those who meet these specific criteria. This web seminar will provide a set of guidelines, instructions, and templates for the writing of clinical and post-marketing case narratives for reporting adverse events.

December 15, 2017

FDAnews

How to Build A World-Class Audit Team

1:30 p.m. - 3:00 p.m. EST

The secret? A super-strong internal audit team — one that spots the issues most often cited in warning letters and nips them in the bud. Not following SOPs. Data integrity and good documentation practices. Incomplete investigations. Ms. Schniepp, a QA expert and award-winning author with 35 years’ experience, walks you through the steps that counter such errors and teaches you: Elements of an effective audit program, including naming members who not only know SOPs, but know whether you’re really following them. Better utilizing internal audit observations to drive continual improvement and remediate shortcomings before it’s too late. Qualities of effective auditors and team leaders — and how to spot them. Good documentation practices — the best prevention against warning letters and other regulatory headaches

December 15, 2017

Barnett International

CAP and CLIA Requirements for Clinical Research Laboratories

1:00 PM - 3:00 PM Eastern

This web seminar will provide a general overview of the College of American Pathologists (CAP) and Clinical Laboratory Improvements Amendments (CLIA) requirements for laboratories that perform routine and non-routine testing of clinical samples for clinical trials. We will review the laboratory requirements for patient care and the requirements for clinical research. Similarities and difference of CAP requirements from ISO 15189 Medical Laboratories Requirements for Quality and Compliance, as applicable, will be discussed. This web seminar provides training for the auditor/inspector assessing clinical laboratories for compliance.

December 18, 2017

Barnett International

Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155

9:30 AM - 11:00 AM Eastern

Both ICH GCP E6 Guideline and ISO 14155 address the elements of Good Clinical Practice in the design, conduct, recording, and reporting of human subject research. Although many sponsors of medical device studies use the ICH GCP E6 Guideline as an ethical and scientific quality standard, ISO is written specifically to protect the rights, safety, and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and Principal Investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

December 19, 2017

Barnett International

Understanding the FDA/OHRP Joint Draft Guidance on Minutes of IRB Meetings

12:30 PM - 2:30 PM Eastern

Institutions and institutional review boards (IRBs) are responsible for oversight of human subject research under HHS and FDA regulations. As part of meeting this responsibility, IRBs must prepare and maintain adequate documentation of IRB activities, including minutes of IRB meetings. Unfortunately, IRBs have routinely been cited in OHRP Determination Letters and FDA Warning Letters for failing to prepare and maintain adequate minutes. In this web seminar, we will discuss the FDA and OHRP Joint Draft Guidance on Minutes of IRB Meetings recommendations and the responsibilities of institutions and IRBs in the preparation and maintenance of minutes of IRB meetings to ensure compliance with regulatory requirements.

December 20, 2017

Barnett International

Use of Electronic Health Record Data in Clinical Investigations

12:30 PM - 2:30 PM Eastern

The FDA recognizes Electronic Health Records (EHRs) as data originators and in many cases, source documentation, which therefore subjects them to inspection. In its draft guidance for the Use of Electronic Health Record Data in Clinical Trials, the FDA expands upon prior guidance and provides its recommendations on the use of EHRs as source, and also outlines the responsibilities for ensuring quality and integrity of EHR data. As such, EHRs should be able to be obtained from multiple sources, they should be shareable, interoperable, and accessible to authorized parties. This web seminar will address recommendations for the use of EHRs as source data in clinical trials.

January 8, 2018

Barnett International

Clinical Trials and the Sunshine Act: The Effect on the Clinical Research Industry

1:00 PM - 2:30 PM Eastern

In an effort to increase transparency, highlight potential conflicts of interest, and ultimately decrease healthcare costs, one element of the Patient Protection and Affordable Care Act (PPACA) – the Sunshine Act – requires disclosure of payments or transfer of value to physicians. These physicians can also be involved in clinical research as Investigators, in which case additional information is required to be reported. Released in February 2013, the final rule requires applicable manufacturers of covered drugs, devices, and biological supplies to gather and report information to be listed on the public website. This web seminar will address the requirements for reporting of information derived from clinical research as well as exceptions for reporting.

January 9, 2018

Barnett International

Risk-Based Auditing: Effective Compliance Strategies

12:30 PM - 2:30 PM Eastern

An audit is defined as a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, the sponsor’s standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). Auditing focuses on the systems that generate this data, whereas monitoring tends to focus primarily on the data. Risk-based approaches to auditing, such as focusing on the most critical data elements, are more likely to ensure subject protection and overall study quality, and will permit sponsors to focus their compliance efforts more effectively. This web seminar will provide an overview of risk-based auditing skills and techniques, and a review of recent GCP audit findings from Clinical Investigators (sites), sponsors, and Institutional Review Boards (IRBs).

January 10, 2018

Barnett International

Good Clinical Practice: Practical Application and Implementation

12:30 PM - 2:30 PM Eastern

This web seminar provides an overview of the structural elements of Good Clinical Practice (GCP). Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to how quality systems, or a lack thereof, impact overall data quality and regulatory risk. This web seminar is designed for professionals with at least two years of experience in the clinical research industry.

January 11, 2018

Barnett International

Introduction to Clinical Research

1:00 PM - 2:30 PM Eastern

Have you ever wondered what clinical trials are and how they are conducted? This web seminar is designed to answer those basic questions. We will look at how drugs progress from discovery to testing in humans, and learn what it takes to obtain approval to treat a disease or condition. We will discuss the similarities and differences between drug and medical device development. Finally, we will review how Good Clinical Practice (GCP) is applied to clinical trials around the world and how it is designed to protect clinical trial participants and ensure that the information obtained during a clinical trial is accurate and reliable.

January 16, 2018

Barnett International

The Revised HHS Common Rule: What You Need to Know Now

9:00 AM - 11:30 AM Eastern

In January 2017, the Revised Common Rule (45 Part 46) was published, providing an update to GCP. The Rule is notable as much for what it does not contain as for what it does. This web seminar reviews the following changes: New/modified definitions; biospecimens and identifiable information; informed consent; broad consent; IRB continuing review; IRB limited review; new/modified exclusions and exemptions, and single IRB requirements for cooperative research.

January 17, 2018

Barnett International

Writing Clinical Study Protocols

12:00 PM - 3:00 PM Eastern

The basis and success of any drug or device development program is the clinical trial protocol. Clinical trials conducted under an IND or IDE cannot begin without a protocol, and yet there is variability between companies and individuals on how to approach writing this critical document. Clinical trials and entire programs have failed because the protocol was not scientifically sound. Knowing how to effectively research and write a clinical trial protocol is essential to a compound achieving IRB and market approval.

January 18, 2018

Barnett International

Protocol Deviations: Documenting, Managing, and Reporting

1:00 PM - 3:00 PM Eastern

According to both U.S. regulations and the ICH GCP E6 Guideline, Clinical Investigators are required to conduct a clinical trial in compliance with the investigational plan/protocol. Protocol deviations should not be implemented without sponsor agreement and the prior approval/favorable opinion from the IRB/IEC, except when necessary to eliminate an immediate safety issue for research subjects.

January 19, 2018

Barnett International

Trial Master Files: Why They Are Important and How to Organize Them Workshop

9:00 AM - 4:00 PM Eastern

The Trial Master File is a collection of the essential documents for a sponsor to record how they have fulfilled their obligations for a clinical trial. The Code of Federal Regulations states in 21 CFR 312.50 that, “Sponsors are responsible for… ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND.” The European Directive 2005/28/EC states that, “the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.” ICH GCP E6 Guideline, Section 8.1 defines these essential documents as those that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.

January 22, 2018

Barnett International

Strategies for Managing Difficult Clinical Research Sites

12:00 PM - 2:00 PM Eastern

Many Clinical Research Associates (CRAs) ask: “How do I best handle a difficult site?” In this web seminar the question is addressed through real life case scenarios that deal with the different kinds of “difficult” sites, for example: The overwhelmed site, the unmotivated site, the passive aggressive site, the research naïve site. All of these types of behaviors at sites can lead to poor performance that does not respond to typical CRA action item management. Hear ideas on how to successfully work with the difficult site to promote efficiency and positive study outcomes that include helpful job aids, soft skill coaching, and diagnostic techniques to help improve approaches to interventions and management of the “difficult” site.

January 29, 2018

Barnett International

Investigational Product Accountability Best Practices

12:00 PM - 2:00 PM Eastern

One of the top regulatory findings both in the U.S. and in global inspections is related to investigational product (IP) accountability. In this web seminar, we will discuss the common sources of error, recommend procedures and training techniques, and evaluate the differences in investigational and non-investigational products. Investigator and sponsor responsibilities will be described, as well as “best practices” for implementation of those responsibilities.

January 30, 2018

Barnett International

Electronic Informed Consent Guidance: Regulatory Updates

11:00 AM - 12:30 PM Eastern

Conducting the informed consent process is one of the most critical tasks to be completed by a research site. It’s essential that a subject clearly understands the information and language in the consent form and that their rights, safety, and welfare are not jeopardized. This web seminar will review the essential language in the informed consent document through review of the FDA regulations and guidance documents, including the December 2016 final guidance, “Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers.” Additionally, there will be discussion of some of the challenges faced in consenting pediatric subjects in trials of greater than minimal risk, the use of translators, and review of the use of electronic informed consent and electronic signatures.

January 31, 2018

Barnett International

Overseeing Teams and Projects

1:00 PM - 3:00 PM Eastern

According to a survey by Ernst & Young, 80% of the issues surrounding project failure are people issues. Project success requires that project managers not only manage projects, but lead people. To do so effectively, they must gain the knowledge, skills, tools, and experiences of other leaders to enable them to manage and lead both the technical and the people side of project management. In this web seminar, participants will review key components of effective communication skills to achieve peak team performance. Team leadership and management, negotiation and influencing skills will also be covered through the examination of different leadership styles and qualities that are required for successful project delivery.