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Webinars

January | February |

January

January 28, 2015

Barnett International

Quality by Design: A Lean Six Sigma Approach to Risk-Based Monitoring

1:00 PM - 2:30 PM Eastern

Monitoring consumes 30-60% of an operational budget for clinical trials or clinical programs. To sustain growth and reinvest in innovation, sponsors must find viable alternatives to reduce the resource burn, as well as create efficient and effective solutions to increase regulatory compliance, data integrity, and patient safety. By utilizing the combined toolboxes of Lean Six Sigma (LSS) + Quality by Design (QbD), sponsors can continue to invest in innovative products while producing customer-centric/efficient operational processes that are highly adaptable, constantly reproducible, and consume fewer resources. LSS + QbD provides CRAs and other risk-based monitoring staff with an arsenal of analytical tools to conduct fewer on site monitoring visits yet monitor the site more effectively and in real-time.

January 29, 2015

Barnett International

Establishing a Vendor Management Program

9:30 AM - 11:00 AM Eastern

As vendor/contractor/subcontractor/supplier relationships and usage increase in use and complexity, vendor management is receiving more attention as a way for organizations to achieve a competitive advantage and make their outsourcing relationships part of their long-term success plan. However, while the benefits of vendor management programs have been widely reported, many organizations still lack the guidelines and tools to successfully implement such a program. This web seminar is designed to present techniques and best practices to establishing and monitoring a vendor management program. During the course, we will discuss the various roles and responsibilities, strategies to categorize and monitor vendors, and the benefits of a vendor management program.

January 29, 2015

Barnett International

Writing Protocols for Diagnostic Studies

12:00 PM - 1:30 PM Eastern

Diagnostic studies vary greatly from standard pharma and device studies, and the documents generated for these studies differ accordingly. This web seminar presents the basic tools required to generate protocols for sample collection, accuracy, and reproducibility studies. Participants will learn the elements of each of these protocols, how they differ from the standard pharma protocols, the guidances to follow for reference, and the regulatory environment surrounding sample collection and informed consents for de-linked samples.

January 29, 2015

Barnett International

Strategies for Conducting Vendor Audits

1:00 PM - 2:30 PM Eastern

Regulatory agencies hold companies accountable for delivering high quality products that meet all established requirements and specifications. Vendors play a key role in accomplishing these mandates and it is the sponsor’s responsibility to ensure their vendors meet all regulatory specifications for the supplied materials, equipment, and/or services. During this web seminar, we will discuss types of vendor audits, various methods/media to conduct vendor audits, planning for the audit, and follow-up to vendor audits.

February

February 2, 2015

Barnett International

Investigator Initiated Trials: Roles and Responsibilities

9:30 AM - 11:30 AM Eastern

Investigator Initiated Trials (IITs), also referred to as Sponsor-Investigator (SI) Trials are increasing in popularity. A Sponsor-Investigator is anyone who functions as the Clinical Investigator (CI) of a given study and who also holds the investigational marketing application, i.e., the IND or IDE. How does the CI ensure compliance to both the investigator and sponsor responsibilities? This web seminar will present the responsibilities, discuss risk, and provide suggestions for compliance.

February 2, 2015

Barnett International

ABCs of Clinical Research for Clinical Administrative Support Staff

12:30 PM - 3:00 PM Eastern

This course provides the background needed to become an integral part of the clinical research team (for drugs and devices) and explores the need to understand the rationale behind quality performance and team-playing. The roles and responsibilities of Clinical Administrative Support will be discussed in terms of obligations to the study team and the importance of compliance with Standard Operating Procedures and Standard Office Practices. Although the course is designed for administrative staff with less than one year experience, those with some experience may also find this course helpful in providing the rationale for doing tasks in a specific manner, refining their skills, and sharing their experiences and helpful techniques with their colleagues.

February 3, 2015

Barnett International

Placebo Trials for Medical Devices: FDA's Steps to Ensure Reliability of Medical Devices

9:30 AM - 11:00 AM Eastern

As of 2014, device companies must consider the placebo effect in clinical trials and how placebo controls will affect their regulatory approval pathway. Randomized, placebo controlled trials are not new to those in the pharmaceutical industry, but they have not traditionally been the norm for device trials. Approval in the EU does not assure approval in the U.S. Will Congress be asked “to ensure that all devices provided to patients be safe and effective” rather than “reasonably” safe and effective? What are the ethical considerations? How will this issue affect conducting medical device clinical trials in the U.S. and abroad? Sponsors should be prepared to discuss and defend their position on the necessity of a placebo controlled trial.

February 4, 2015

Barnett International

Establishing a Risk Management Framework for Clinical Trial Conduct and Oversight

1:00 PM - 2:30 PM Eastern

As many organizations move to, or contemplate, a risk-based approach to trial conduct and quality management, the published regulatory agency documents and industry think tank publications fall short in providing sponsors, CROs, and clinical vendors the framework—a comprehensive, systematic, structured approach to implementing risk management. This web seminar will provide an overview of a risk management reference model for use that has been adopted by other industries and is referenced in the FDA Guidance of 2013, “Oversight of Clinical Investigations — A Risk- Based Approach to Monitoring.”

February 5, 2015

Barnett International

Data Quality in Clinical Trials: Rationale and Impact

12:30 PM - 2:30 PM Eastern

Good Clinical Practice (GCP) is the universal ethical and scientific quality standard for conducting clinical trials. The GCP standard applies to all aspects of the clinical trial process. Adherence to the GCP quality standard during the clinical trial process provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of the trial subjects are protected.

February 6, 2015

Barnett International

Monitoring Phase I 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 specific components for monitoring studies in this phase of research. References from GCP to support monitoring activities will be presented, as well as case studies to apply presented concepts.

February 9, 2015

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.”

February 10, 2015

Barnett International

Use of Notes to File in Clinical Trial Essential Documentation

8:30 AM - 10:00 AM 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.

February 10, 2015

Barnett International

Monitoring Oncology Clinical Trials

9:30 AM - 11:30 AM Eastern

This web seminar will provide attendees with a general overview of oncology clinical trials and their distinct characteristics. We will review how oncology clinical trials differ from those in other therapeutic areas, with a special emphasis on the unique challenges of monitoring oncology clinical trials. Distinctions will be drawn between early and later phase trials. Attention will be paid to Adverse Event (AE) and Serious Adverse Event (SAE) reporting. All aspects of oncology clinical trials and how to successfully monitor them will also be discussed.

February 10, 2015

Barnett International

Monitoring Reports: 10 Rules of Effective Report Writing

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.

February 10, 2015

Barnett International

Managing CRAs to Improve Study Outcomes

12:00 PM - 2:30 PM Eastern

Monitoring a clinical trial is a required activity completed by sponsors of FDA regulated research that significantly affects the outcomes of product development and approval. Effectively managing the performance of Clinical Research Associates (CRAs) by sponsors is essential. Performance Management and Improvement is a science involving logical processes and applications. This web seminar will present the concepts of the Human Performance Improvement (HPI) Model and apply it directly to the management of the CRA to promote improvements. The HPI CRA Management Model will be presented and applied via case scenarios for better understanding.

February 11, 2015

Barnett International

Subject Recruitment: Proactive Project Plans and Issues Management

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, insourcing and outsourcing options, and social media considerations. Included in the program are discussions for handling tough populations and the ethics of participant recruitment in clinical trials.

February 11, 2015

Barnett International

Writing and Updating the Investigator's Brochure

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.

February 12, 2015

Barnett International

The CRA Role in Risk-Based Monitoring: Strategies for Effective Remote Monitoring

9:30 AM - 11:00 AM Eastern

Strategies for saving time and money, without compromising oversight and quality, are an ongoing challenge within the industry. In an age where technology is ever present from ordering medications online, consulting with a physician, and having “live” conversations in chat rooms about medical issues, the clinical research industry has been slow to maximize the use of technology. With sponsors/CROs implementing the FDA’s final guidance on a risk-based approach to monitoring, time on site is being reduced to one day visits and/or on-site visits are scheduled few and far between per monitoring plans. Better utilization of remote monitoring is critical to ensure sites are compliant and the data is accurate and consistent. During this web seminar, strategies for remote monitoring will be discussed, including the review of data for trends, how to make the most of writing queries, and what “red flags” to look for that may indicate issues on site.

February 12, 2015

Barnett International

CRO Selection Criteria, Evaluation, and Establishing the Relationship

1:00 PM - 2:30 PM Eastern

Outsourcing to Contract Research Organizations (CROs) to complete studies has become a foundation for pharmaceutical and device companies. With the lengthy drug development and approval process, it is nearly impossible to have complete study teams kept as full-time employees as the workload continually ebbs and flows. One of the challenges of outsourcing is selecting the right partner and then maintaining a team atmosphere where everyone takes ownership of the study. Key considerations when collaborating successfully with a CRO are selecting the right partner by knowing what questions to ask; establishing a foundation for the partnership with clear expectations, goals, and communication; and maintaining a sense of ownership in the work that has been outsourced. This web seminar will address the key criteria in selecting a partner, as well as review the necessary processes to foster positive relationships and allow for high quality performance of the CRO.

February 13 - May 1, 2015

Barnett International

10-Week Clinical Research Coordinator (CRC) On-Boarding Program

8:30 AM - 11:30 AM Eastern

The Clinical Research Coordinator (CRC) has a vital role in the conduct of a clinical trial and is a key liaison between the investigator, subject, IRB, and sponsor. The online 10-Week Clinical Research Coordinator (CRC) On-Boarding Program will provide a comprehensive introduction to clinical research and the job functions of the CRC for both drug/biologic and device trials. This program will provide core skills and encourage critical thinking to those individuals looking to support, facilitate, and coordinate the daily activities of clinical trials. Case studies and industry best practices will be presented to underscore how the learning objectives apply directly to the responsibilities of the CRC.

February 13, 2015

Barnett International

Approaches to Address Challenges in Vendor Management

12:00 PM - 2:30 PM Eastern

Outsourcing in clinical development continues to grow and so do the challenges of ensuring quality outcomes. Managing a vendor vs. micro-managing a vendor will be discussed with some practices to improve the relationship. Recommendations for sponsor oversight practices are discussed with a review of helpful tools.

February 17, 2015

Barnett International

Detecting Risk Signals in Protocols, Data, and Monitoring

9:30 AM - 11:00 AM Eastern

In an environment where remote monitoring and management techniques are becoming the daily practice, preventative measures need to be implemented to identify risks. You need to be able to identify protocol data thresholds and parameters for risks to establish management and escalation triggers. As data becomes available in real time, you should not be waiting to intervene until deviations become a “trend” before intervention is implemented; you need to know how to look for outliers and “red flags” on a daily basis. With the increasing use of CROs and vendors, it is essential that best practices are established for identifying risk signals in management and monitoring practices. In this web seminar, we will discuss how to detect risk signals in protocols, data, and monitoring based on risk-based quality management, industry guidances, and practical application.

February 17, 2015

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.

February 17, 2015

Barnett International

RECIST 1.0 and 1.1: Overview and Data Challenges in Oncology Clinical Trials

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.

February 18, 2015

Barnett International

Principal Investigator Oversight and the Appropriate Delegation of Tasks

12:00 PM - 1:30 PM 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.

February 18, 2015

Barnett International

Adequate Sponsor Monitoring Systems in Anticipation of FDA Sponsor GCP Inspection

12:30 PM - 2:30 PM Eastern

In the current regulatory climate, sponsors should anticipate more FDA sponsor GCP inspections and information requests regarding monitoring practices. Many monitoring systems lack components that ensure proper management of the research site without relying on the “star performer.” Monitoring systems should include specific components to ensure control of investigational product, data integrity, oversight of vendors, as well as other areas. The components of a quality monitoring system will be presented so that participants can assess their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections of sponsor monitoring programs.

February 18, 2015

Barnett International

HIPAA Team Training: Fundamental Training Specifically for Clinical Research Setting

2:00 PM - 5:00 PM Eastern

HIPAA Team Training has been designed as a course presenting concepts and terminology of HIPAA specific to conducting clinical trials. The web seminar presents the core elements with methodologies for blending the concepts into established clinical trial best practices. The focus of the course is to train sponsors/CROs and site clinical researchers HIPAA concepts for later application in day-to-day roles.