12:30 PM - 3:30 PM Eastern

Fueled by the encouragement from regulatory agencies in the U.S. and Europe, the art and science of pediatric drug development has evolved rapidly in pharmaceutical companies over the last few years. Due to recent governmental initiatives such as the Pediatric Research Equity Act (PREA) in the U.S. and Pediatric Investigation Plans (PIPs) in Europe, pharmaceutical companies have been given clear pathways and incentives to develop drug indications and products for this important group of patients. This web seminar will examine these regulatory initiatives and discuss practical and effective development approaches and study designs.

12:00 PM - 1:30 PM Eastern

The Common Technical Document (CTD) format is now the required format for all marketing applications in the U.S., EU, Japan, Canada, and Australia. Clinical Trial Applications (CTAs), the required format of INDs in most countries, are required to be in the CTD format. Currently, the U.S. does not require INDs to be in the CTD format, but rather the traditional format (per regulations in 21 CRF 312.23). However, since all marketing applications are required in the CTD format, it is more efficient to start the IND in the CTD format. If you use the traditional format, the IND and all amendment information must be converted to the CTD format prior to marketing application submission. This conversion time can impact the timeline for marketing application submission, so why not plan ahead for a successful marketing application and start the IND in the CTD format?

1:00 PM - 2:30 PM Eastern

This web seminar will cover the fundamentals of signal detection, and how signal detection can be augmented by the use of data mining techniques. The requirement for companies to perform signal detection is now mandatory in Europe and highly recommended in the U.S. Many simple techniques can be applied to the generation and review of potential signals, which can also be augmented by the application of sophisticated data mining algorithms.

12:30 PM - 3:30 PM Eastern

This web seminar provides a review of FDA requirements for approval of a Biosimilar product. The Biosimilar product approval pathway and the underlying Scientific/Quality/Regulatory principles involved are covered, along with guidelines for each aspect of biosimilar research. Additionally, the FDA Stepwise Approach to demonstrating Biosimilarity will be discussed, as well as general considerations on animal/clinical/in vitro studies. Finally, FDA’s Totality-of-the-Evidence approach will also be covered.

8:30 AM - 11:30 AM Eastern

Register by January 31 for only $1,695.00

The online 10-Week Clinical Research Associate (CRA) “on-boarding” training course is appropriate for individuals who have less than two years experience as a Clinical Research Associate. The course provides practical, hands-on training as it relates to the CRA job function, and covers core sponsor and research site activities that promote the successful monitoring of studies for both drug/biologic and device trials. The course follows an ICH/ISO global GCP framework, and covers how to identify specific country requirements, making it appropriate for both US and global audiences. Core Good Clinical Practice (GCP) skills are reinforced through a combination of activities, including lecture, case studies, and scenario review, as well as application-based homework assignments.

12:30 PM - 3:30 PM Eastern

Street Primed is an interactive web seminar that provides clinical research professionals who have to travel/visit high crime areas with a practical approach to personal safety. The course is based on the every day job of a Clinical Research Associate, life sciences sales rep, medical liaison, and anyone else who needs to travel. You’ll learn how to avoid risky situations within the context of daily tasks: Before you leave home; in the car; getting to and from your car and the healthcare offices/sites; in the healthcare offices. By being READY – ALERT – CONFIDENT with your safety, you can focus on what you do best – your job. (Note: Street-Primed is not a self-defense course.)

9:30 AM - 11:30 AM Eastern

Fraudulent activities in clinical research undermine clinical research professionals’ ability to meet their obligations for ensuring credible data is obtained from protected participants. This web seminar provides an overview of fraud in clinical research and its potential impact on the industry and the public’s health.

12:30 PM - 2:30 PM Eastern

This web seminar includes a detailed review of the FDA’s Compliance Program Guidance Manual (CPGM) on how agency investigators are trained to conduct inspections of sponsors, Contract Research Organizations (CROs), and monitors involved in the conduct of clinical research. The course will look at the FDA’s current focus during inspections and the factors driving these changes. Assessment and discussion of the standard operating procedures that are expected for sponsors and CROs, including registration of trials and informed consent document issues, will be highlighted.

12:30 PM - 2:00 PM Eastern

Human subject protection (HSP) regulations haven’t kept pace with the evolution of clinical research. As a result, the regulatory requirements are unclear, inconsistent, and outdated. In response, the DHHS, the United States’ agency that houses both OHRP and the FDA, recently released its announcement for proposed rule changes to the regulations that govern the conduct of human subject research in an effort to streamline, modernize, and increase their effectiveness.

12:00 PM - 2:30 PM Eastern

The role of the research site is vital in the success of a clinical trial. Quality research sites are in great demand in the current research environment. This web seminar presents an overview of the core components for a successful research site. Examples of successful sites for benchmarking will be included as well as resources for more information.

12:00 PM - 2:00 PM Eastern

During monitoring visits one of the most important and impacting activities that a Clinical Research Associate (CRA) performs is the source document verification of Adverse Events (AEs). The CRA is the eyes for the research sponsor when it comes to proper collection and documentation of subject safety information. Incorrect and inadequate monitoring of AEs can lead to inaccurate labeling for clinical trials and impact market application inspectional reviews, as well as post marketing labeling. The safety regulatory and ICH definitions will be reviewed and applied to the monitoring process. This includes Causality, Expectedness/Unanticipated, and other important concepts. Case scenarios will be used to apply the information for better learning.

12:00 PM - 3:00 PM Eastern

During the course of clinical research, the Investigator’s Brochure (IB) is the data repository for an investigational product; effectively this is the product’s “label” during the investigational stage. The IB is a dynamic document which changes as the information changes. It is critical in clinical research as physicians and Institutional Review Boards (IRBs) refer to the IB on an ongoing basis to answer questions about Serious Adverse Events, Adverse Events, dosing, manufacturing, and clinical and nonclinical study results.

12:00 PM - 2:00 PM Eastern

The Clinical Research Associate (CRA) position is both demanding and extremely rewarding. This web seminar provides tips and strategies to help the new CRA navigate his/her early years in the profession. Topics ranging from the practical (packing and travel tips) to the philosophical (how to earn trust and credibility) are covered. Participants will also learn how to set the stage for success as a CRA from a veteran monitoring professional.

12:00 PM - 2:30 PM Eastern

The generation of queries and updating of the clinical trials database from query resolution and other external sources is a crucial step in clinical data generation. Database updates must link to the proper locations, and data must be checked for validity and consistency prior to updating the clinical trials database.

1:00 PM - 3:00 PM Eastern

RECIST stands for Response Evaluation Criteria in Solid Tumors. The National Cancer Institute is the best resource for information, and defines RECIST criteria as “a voluntary, international standard, and not an NCI standard. They are based on a simplification of former methods (WHO, ECOG) and based on measurable disease, i.e., the presence of at least one measurable lesion.” RECIST criteria provide a way to standardize measurement of solid tumors worldwide for any clinical trials that include this data to define study endpoints.

8:30 AM - 11:30 AM Eastern

Negotiating study contracts and budgets is critical for the future success of the clinical research site. This web seminar provides strategic skills and best practices for contract negotiations and budget development. Learners will also review and practice the art of negotiation.

12:00 PM - 1:30 PM Eastern

Observational studies in the biopharmaceutical and medical device industries encompass various designs and purposes, including post-approval safety studies, product or disease registries, pregnancy registries, medical chart reviews, and cohort studies. This web seminar offers practical approaches to the management of observational studies, focusing on issues and aspects that occur commonly, differ from clinical trial management, and are key to program success. Topics to be addressed include project oversight, ethics/Institutional Review Board (IRB) approvals, data quality management, site and subject recruitment and retention, and protocol adherence.

12:30 PM - 2:00 PM Eastern

Widely reported industry statistics suggest that some 86% of trials fail to meet their enrollment goals. Inevitably, one intervention that is often considered is whether or not to hold a study rejuvenation meeting or site engagement meeting as a means for re-motivating investigators to accelerate enrollment. This web seminar is designed to help clarify what is an effective rejuvenation meeting, what goes into the planning, how it should be structured, and what the expected outcome looks like. At the heart of the matter is diagnosing and troubleshooting the enrollment or site engagement issues, and applying some specific parameters around the decision-making to determine whether the time and resource investment to hold a rejuvenation meeting (or series of meetings) is warranted for the potential return on investment.

12:00 PM - 3:00 PM 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.

12:00 PM - 1:30 PM Eastern

As adult learners, clinical research professionals are motivated by an understanding of how training interactions directly impact their work lives. The use of job aids and checklists can serve to satisfy this need by providing a resource to someone performing a task exactly when and where they need it. These tools can also serve to reinforce the training as participants return to the workplace, resulting in a greater likelihood that the organization’s performance goals will be met. In some cases, a job aid alone can replace unnecessary training expenses.

12:00 PM - 2:00 PM Eastern

According to both U.S. regulations and the ICH Good Clinical Practice: Consolidated 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. However, unapproved protocol deviations occur in every study and at every site.

12:00 PM - 1:30 PM Eastern

The ability to negotiate effectively is a core competency for all clinical research professionals. Yet many people find negotiating to be an intimidating experience. Take this interactive web seminar and dramatically improve your ability to negotiate in any situation. With specific examples and real world case studies drawn from clinical research, you will be able to immediately implement the skills you learn with ease. This web seminar will provide a rich learning experience in implementing negotiation best practices.

12:30 PM - 3:30 PM Eastern

This web seminar provides an overview of the drug development process. Included are the Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) regulations and how they interact in the drug development process.

9:00 AM - 4:00 PM Eastern

Clinical Monitors (CRAs) must document many details of the happenings at investigational sites, including Confirmation Letters to sites, Monitoring Visit Reports, Follow-Up Letters to sites, Telephone Contact Reports, Email/Faxes to sites, and Queries and Notes to File (NTF). All of these become essential documents as they demonstrate the compliance of the monitor and, thus, the sponsor in the conduct of the clinical trial. These are all eligible for inspection by the regulatory authorities at any time both during and after the study is completed and submitted for product approval. This is the same regulation for drugs, biologics, and devices. Effective writing skills are, therefore, extremely important so that we show the diligence and detail involved in effective monitoring. Increasingly, we notice that the Confirmation Letters, Monitoring Visit Reports, and Follow-Up Letters have discrepancies. This may be simple date inconsistencies, or critical data credibility issues. It is important that the monitor be aware of the importance of these issues in the review of study documentation. This module will provide some practical solutions to addressing document deficiencies as well as provide a practical understanding of how these documents provide evidence for the regulated activities of the investigator and the sponsor.

12:00 PM - 1:30 PM Eastern

The FDA has announced the release of a guideline for informed consent, “Guidance on Exculpatory Language in Informed Consent.” The guidance is aligned with the Office for Human Research Protections’ (OHRP) recommendations, and many useful examples are included. In this web seminar, we will review examples of Informed Consent Form (ICF) language, and discuss how to apply the recommendations of the guideline to ICFs.

12:00 PM - 1:30 PM Eastern

Notes to File (NTF), also known as Memo to File, are commonly used as essential documentation in sponsor and site files. Many times the content of the NTF does not serve the purpose for use or serves no purpose at all. This web seminar will discuss the appropriate and inappropriate uses of NTF, the questions to ask to determine if NTF would be beneficial, and the components of a quality NTF, if being used.

9:00 AM - 10:30 AM Eastern

The FDA’s Guideline for the Monitoring of Clinical Investigations (1988-2010) has been removed from the FDA list of guidance documents. Instead, the FDA has released an updated version of the Bioresearch Monitoring (BIMO) Compliance Program Guidance Manual for Sponsor/CRO and Monitoring, and most recently the agency released a draft guidance to reflect their expectations and recommendations related to monitoring investigation sites, monitoring systems, and investigative site oversight. In this web seminar, the content and the implications to sponsor monitoring and clinical investigation sites will be discussed.

12:30 PM - 2:30 PM Eastern

This web seminar is designed for sponsor/CRO personnel responsible for protocol design and development, country allocation, site selection, and study feasibility assessments. It’s a welldocumented fact that the current study feasibility assessment process is inefficient and is incapable of identifying the best investigative sites to conduct a clinical trial. Feasibility questionnaires and the current process are often not effective in predicting site success in implementing a given clinical trial. This session will explore novel approaches and technologies that can be used to significantly improve the feasibility assessment process at the protocol, country, and site level. Examples of the use of these novel techniques and their excellent results in practice will be provided.

1:00 PM - 2:30 PM Eastern

Protocols are rising in complexity, length, and numbers of procedures. Protocol training is trending toward webinars vs. live meetings where questions are more limited and less likely to be asked. With more to do and less time and instruction, taking on new and challenging protocols can be daunting. This web seminar will focus on some introductory steps to taking a protocol apart and making it operational and executable without deviations at a site. Topics to be addressed include how to get the most out of the initial protocol review, understanding and putting into practice the patient flow, and how to ensure protocol adherence in a busy, ever-changing site environment.

9:00 AM - 10:30 AM Eastern

Principal Investigators (PIs) are required to provide adequate oversight of all clinical research activities at the site, whether the activity is conducted by the PI, by study team members, or by applicable third parties. Adequate oversight encompasses many activities and obligations, such as ensuring regulatory compliance, staff training, and subject medical care. In this web seminar, we will discuss the regulatory requirements and guidance regarding adequate investigator oversight and appropriate delegation of study tasks, review documentation requirements, and determine strategies for appropriate delegation of tasks.

12:00 PM - 2:00 PM Eastern

This web seminar presents an overview of the patient recruitment arena, and focuses on strategies for successful clinical trials including systematic protocol feasibility, pre-screening approaches, and insourcing and outsourcing options. Included in the program are discussions for handling tough populations and the ethics of participant recruitment in clinical trials.

12:00 PM - 2:00 PM Eastern

Phase I trials require an additional monitoring skill set. The Clinical Research Associate (CRA) assessment focus changes in many monitoring practices, from the Informed Consent Form to data review of PK sampling. Most CRA trainings do not test or provide practicum for the unique focus of a Phase I trial. This web seminar will identify the differences in skills and review certain components of this type of monitoring. Tools to support the activities will be presented, as well as case studies to apply certain concepts.

12:00 PM - 2:00 PM Eastern

Investigator non-compliance to the Statement of Investigator commitments has increased in many areas. One of the identified causes has been monitoring. Investigator compliance issues are great risks to product development success, but an even greater risk to sponsors is the lack of formal systems to manage compliance at research sites. With the promise of more sponsor inspections, the sponsor management of investigator noncompliance is an obligation that requires comprehensive management approaches that lead to control of investigational product, data integrity, and adequate documentation for regulatory inspection of sponsors monitoring programs and/or investigative sites. Seven steps in compliance management of research sites will be presented for the participants to assess their current practices for gaps and risks for preparing for potential regulatory inspection evaluating compliance management of research sites.

12:00 PM - 2:30 PM Eastern

The Clinical Research Coordinator (CRC) can be a key liaison between the investigator, subject, Institutional Review Board (IRB), and sponsor. The CRC assists the investigator to ensure that the clinical trial is successfully implemented and completed. This web seminar presents the core skills and activities performed by the CRC and the documentation requirements that come along with clinical trials.

1:00 PM - 3:00 PM Eastern

This web seminar provides newcomers a thorough introduction of FDA regulations in the field of medical device safety. The course includes a comprehensive review of the requirements, current compliance approaches for professionals in the research and post-marketing areas, and opportunities to discuss the challenges facing those reporting and managing Adverse Events in the medical device industry.