CenterWatch

Training Programs

To have your training program included, please contact jobwatch@centerwatch.com.

November

Phlebotomy Training in 2 days!

Learn to draw blood quickly. The program consists of one day online training at your own pace and one day hands-on training in the classroom setting. We come to your location. Train now!

www.phleb.com/privategroups.html

November 30 - December 1, 2016

Clinical Project Management: Intermediate
San Francisco, CA

The course builds on project management basics to examine some of the more difficult issues encountered by clinical project managers. It examines approaches for optimizing clinical trial conduct and includes discussion of current hot-button concerns facing clinical project managers.

Take advantage of our $1,595.00 price by registering early! * After October 31, costs are $1,795.00.

December

Phlebotomy Training in 2 days!

Learn to draw blood quickly. The program consists of one day online training at your own pace and one day hands-on training in the classroom setting. We come to your location. Train now!

www.phleb.com/privategroups.html

December 1-2, 2016

Auditing Techniques for Clinical Research Professionals
Philadelphia, PA

This workshop teaches practical, immediately usable techniques that top-notch Good Clinical Practice (GCP) auditors and FDA investigators employ. They include techniques that are useful when auditing clinical trials that employ Electronic Medical Records (EMR) and/or Electronic Data Capture (EDC). When monitors and auditors apply these techniques, they can better detect, correct, and prevent clinical study performance deficiencies at clinical sites and within their organizations. Significant updates to the seminar focus on the development and utilization of Quality Systems (QS) at clinical sites to improve their performance. The workshop will emphasize Simple Efficient & Effective QS processes that clinical site personnel can utilize and how monitors and auditors can help them develop and implement them.

Take advantage of our $1,595.00 price by registering early! * After October 31, costs are $1,795.00.

December 1-2, 2016

Drug Safety and Pharmacovigilance: Effective Drug Safety Reporting and Surveillance
Boston, MA

This course covers the fundamentals of drug safety and pharmacovigilance, including regulatory requirements, adverse event reporting, signaling and risk management. The course addresses the regulatory issues across US and EU agencies that improve safety, but slow down the product approval process. Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence, and regulatory compliance. This course will provide learners with regulatory references, processes, best practices, and analysis and investigation techniques to minimize risk, avoid product recall, and meet US and EU safety reporting standards.

Take advantage of our $1,595.00 price by registering early! * After October 31, costs are $1,795.00.

December 1, 2016

Patient Recruitment and Retention: Successful Planning and Management
San Francisco, CA

What does it take to successfully plan and implement a successful patient recruitment and retention program be it at the local site level or study-wide level? What’s the difference between recruitment sources, strategies and tactics? What are the elements that fundamentally influence or determine a patient’s participation in the trial? When and how should recruitment planning discussions take place vis-à-vis the study feasibility assessment process? What’s the link between site engagement and successful patient recruitment and retention? If you are interested in exploring the answers to these and other questions, then this seminar is for you. Going beyond a discussion of advertising and outreach tactics, this course will systematically evaluate both theoretical as well as practical aspects of all of the factors necessary for an effective patient recruitment and retention program.

Take advantage of our $800.00 price by registering early! * After October 31, costs are $1,000.00.

December 2, 2016

Informed Consent - Beyond the Basics
San Francisco, CA

This intensive course provides a detailed exploration of best practices surrounding the development of informed consent and patient educational materials as well as tools and methodologies for obtaining informed consent. Going beyond the minimum regulatory requirements, this course offers practical as well as theoretical information for enhancing the informed consent process.

Take advantage of our $800.00 price by registering early! * After October 31, costs are $1,000.00.

December 5-6, 2016

Advanced Good Clinical Practice: Practical Application and Implementation
Boston, MA

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 $1,595.00 price by registering early! * After November 4, costs are $1,795.00.

December 6-7, 2016

Adverse Events: Managing and Reporting for Medical Devices
Boston, MA

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 $1,595.00 price by registering early! * After November 4, costs are $1,795.00.

December 6-8, 2016

CRA & CRC Beginner Program
Philadelphia, PA

This beginner course provides an excellent introduction to clinical research and the job responsibilities of Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs). It explores topics relevant to those considering a career as an entry-level CRA or CRC. Specifically, this course is appropriate for individuals seeking a new career or career change, but don’t know which job track within clinical research to pursue. The course includes an appendix of time management and interviewing tips.

Take advantage of our $1,695.00 price by registering early! * After November 4, costs are $1,895.00.

December 6-7, 2016

Developing CRAs as Site Study Managers
San Francisco, CA

The person that has the most contact with the site is the Clinical Research Associate (CRA); they are the “face” of the sponsor, the purveyor of information, and the person that most influences the site’s performance on a study. In a sense, CRAs are the sponsor’s On-Site Study Managers. It is critical that this individual be in a position to positively reflect the sponsor and ensure the site performs to their full potential through training, knowledge, and support. CRAs must understand the data review process, but they must also havethe skills to train, mentor, and communicate with new and experienced site staff, and to navigate the path through challenging situations. In addition, the CRA needs to be equipped and prepared to communicate with the Principal Investigator (PI) and be able to support the site in recruitment efforts and the documentation process. A better understanding of adult learning techniques, unique and thorough approaches to recruitment and retention strategies, carefully developed and implemented communication plans, and an understanding of project management techniques can make the difference between a site meeting enrollment with minimal deviations, and a site lacking in enrollment with multiple protocol violations. This course will focus on a variety of techniques and training to help CRAs move from monitors to on-site study managers in their skills.

Take advantage of our $1,595.00 price by registering early! * After November 4, costs are $1,795.00.

December 6-7, 2016

Medical Device GCP Overview
Boston, MA

This course provides information across the full range of medical device clinical trial activities. It is an ideal source of information for those new to clinical research and those requiring information specifically relating to regulatory and practical aspects of medical device clinical research.

Take advantage of our $1,595.00 price by registering early! * After November 4, costs are $1,795.00.

December 6-7, 2016

Monitoring Oncology Clinical Trials
San Francisco, CA

This course is designed for Clinical Research Associates (CRAs) currently working in the industry who are interested in gaining knowledge about monitoring in the oncology therapeutic area. As the demand for CRAs in the oncology arena continues to grow, this course offers practical, hands-on training covering oncology-specific logistical, clinical, and ethical considerations. The application of clinical monitoring skills to oncology trials is reinforced through interactive discussions, case studies, and practice-based activities. The course content is also valuable to Project Managers and CRA Managers working in the oncology field as they seek to design feasible protocols, clinical monitoring plans, and monitoring tools adaptable to the unique requirements of these study sites and trials.

Take advantage of our $1,595.00 price by registering early! * After November 4, costs are $1,795.00.

December 6-7, 2016

Statistical Concepts for Non-Statisticians
San Francisco, CA

Designed for non-statisticians, this basic statistical concepts workshop has direct applicability to clinical research. The choice of statistical method, the application of statistical principles, and the interpretation of statistical results are the foundation of the design and analysis of clinical trials. It is therefore critical that statistical methods are fully understood before they are implemented. This course is beneficial to all clinical research professionals involved in the design, monitoring, interpretation, and reporting of clinical trials. Please note that this is not a course on statistical formulas or computations.

Take advantage of our $1,595.00 price by registering early! * After November 4, costs are $1,795.00.

December 6-7, 2016

The Highly Effective CRA: Soft Skills for Taking Your Work to the Next Level
Philadelphia, PA

Good monitoring skills are not the only critical skills a CRA needs to be effective in their role. A highly effective CRA is a great communicator; focuses on building relationships and partnership with their key stakeholders to position their projects/studies for success; resolves conflict with confidence, bravery, and laser-sharp solution focus; is able to anticipate potential challenges and barriers to success and takes the steps to remove and/or mitigate them; and identifies and solves problems.

This course is for the CRA who wants to build upon their existing communication, problem solving, and conflict resolution skills, and ultimately increase their effectiveness at the study site. Through highly interactive role-play and real-world case study activities, we will address:

  • How do I drive results when I do not have direct authority over the investigator?
  • How do I have the tough conversations with the investigator and her/his staff?
  • How can I move from reacting to challenges to anticipating and removing barriers to success?
  • How do I take my work to the next level of effectiveness?

Take advantage of our $1,595.00 price by registering early! * After November 4, costs are $1,795.00.

December 7-8, 2016

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.

Take advantage of our $1,595.00 price by registering early! * After November 4, costs are $1,795.00.

December 7, 2016

Case Report Form Design, Strategy, and Standards
Philadelphia, PA

According to the Society for Clinical Data Management (SCDM) Good Clinical Data Management Practices (GCDMP): “…no document in a clinical trial (other than the study protocol) is more important than the instrument designed and used to acquire data. The quality of the data collected relies first and foremost on the quality of this instrument. Regardless of the time and effort spent conducting the trial, the correct data points must be collected; otherwise, a meaningful analysis of the study’s outcome may not be possible. Therefore, it follows that the design, development, and quality assurance of such an instrument must receive the utmost attention.”

Other regulations, such as the ICH E6 Good Clinical Practice guidelines, identify the Case Report Form (CRF) as one of the essential documents for a clinical trial. Therefore, it is imperative to understand and implement the best practices of the CRF design process. That includes making sure all the protocol-required data are collected, ensuring the design of the CRF minimizes errors, and keeping the study coordinator in their normal workflow.

It is also important to consider the future compilation of data from multiple clinical trials for agency submission and the assurance that data collection is consistent, concise, and compatible, hence, the need for standards. CDISC and CDASH are instrumental in the establishment of these standards.

This workshop will discuss the principles of good CRF design, the timing of CRF design in relation to clinical trial start-up, and the team that will contribute to the data collection recommendations. Participants will review a sample protocol and determine which CRFs will be required to collect the appropriate data. We will discuss design philosophies and rationales and apply these principles in reviewing CRFs to critique design. We will also discuss the resources that are utilized in determining what data collection is required and the current standards for CRF data content.

The module based on best practices for CRF design as documented in the SCDM GCDMP will provide the understanding of the expectations for purposeful CRF design.

Note: This workshop will deal with the principles and fundamentals relating to data elements for good CRF design. It is not intended as a training in a software application to create the CRF.

Take advantage of our $800.00 price by registering early! * After November 4, costs are $1,000.00.

December 8, 2016

How to Write Great SOPs and Work Instructions
Philadelphia, PA

Standard Operating Procedures (SOPs) and Work Instructions are of high value when they are written properly. Too often authors leave out the right details to make these documents user-friendly and add-in items can cause confusion and lead to misunderstandings and at worse, non-compliance. This course presents a best practice for developing SOPs and Work Instructions starting with the critical technique of process mapping. In this seminar, learners will be taught the various components of each document and tips on how to write effective, user-friendly SOPs and Work Instructions. Participants will have an opportunity to bring a draft SOP and/or Work Instruction to the class and obtain feedback.

This is a highly practical course with real-world tips from persons in the field who create, review, and audit these documents.

Take advantage of our $800.00 price by registering early! * After November 7, costs are $1,000.00.

December 8, 2016

How to Write Effective Monitoring Reports and Communications
Boston, MA

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.

The monitor visit starts with a well-written Confirmation Letter informing the investigator and investigator’s staff of the expectations of the upcoming visit. An accurate and complete Monitoring Visit Report details all of the activities of the monitor in meeting the sponsor’s obligation during the actual monitor visit, including action items and demonstrable management of the site by the monitor. Queries must be well-written if they are to be understood by the study coordinator or Principal Investigator at the site. The Follow-Up Letter, which must detail the progress made on this visit and highlight any deficiencies for which the monitor expects resolution must agree with the action items listed in the Monitoring Visit Report. Written documentation of Telephone Contacts must be direct, accurate, and timely; other communications between monitor visits need to be associated with the proper events as well. This module will provide an understanding of the information required, importance of timely and well-documented discussions, and proper methods of filing this key documentation. This workshop is invaluable for the CRA as well as the individual who critiques the various reports.

Take advantage of our $800.00 price by registering early! * After November 7, costs are $1,000.00.

December 13-15, 2016

Comprehensive Monitoring for Medical Devices
San Francisco, CA

This course provides an in-depth overview of the medical device development process and the role of the Clinical Research Associate (CRA) in managing and monitoring medical device studies. This course is ideal for CRAs new to the device industry, as well as experienced CRAs who are transitioning from monitoring drug studies to monitoring device studies.

Take advantage of our $1,695.00 price by registering early! * After November 11, costs are $1,895.00.

December 13, 2016

Medical Writing Fundamentals: How to Write Regulatory Documents
San Francisco, CA

This Medical writing has its own standard practices and idiosyncrasies. Knowing what to write, how to format, and how to navigate corporate processes can require a big learning curve. This seminar will give learners a broad understanding of writing practices, formatting, working with tables and figures, and communicating effectively. Practical applications of these skills will be described as they apply to writing all types of documents for submission to global regulatory authorities, including protocols, clinical study reports, investigator’s brochures, data management plans, statistical analysis plans, documents for modules in the Common Technical Document (CTD) format, and briefing books. In addition, real-life examples of strategies for generating a great document each time by understanding the what and why of the different documents will be presented.

Take advantage of our $800.00 price by registering early! * After November 11, costs are $1,000.00.

December 13-15, 2016

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. References and resources (including those available online) will be provided. Best practice techniques for site management will be provided. 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.

Take advantage of our $1,695.00 price by registering early! * After November 11, costs are $1,895.00.

December 13-14, 2016

Working with CROs: Building a Partnership for Project Success
Philadelphia, PA

This course provides an in-depth overview of Contract Research Organization (CRO) evaluation,selection, management, and trouble shooting. Various types of CRO relationships will be addressed including outsourcing to lab vendors,niche specialty providers, data management,and overall study management and monitoring. Beginning with a review of the Request for Proposal (RFP) process, the course will take you through follow-up analysis and debriefing of the CRO partnership.

Take advantage of our $1,595.00 price by registering early! * After November 11, costs are $1,795.00.

December 14-15, 2016

Effectively Writing Clinical Trial Protocols
San Francisco, CA

The basis and success of any clinical development program is the study protocol. Clinical trials conducted under an IND or IDE cannot begin without a protocol. However, there is considerable variability between companies and individuals regarding the approach to writing this critical document, even with a good understanding of ICH guidelines. 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 achieving IRB and ultimately market approval. Over the course of development, new protocols, protocol amendments, and protocol concept sheets are needed on an ongoing basis. Though they require similar information, protocols for drugs, biologics, and devices require different approaches, and may be dependent on phase of development. Moreover, amendments, however unwelcome, are a necessary part of the development process. Amendments must be managed efficiently to avoid costly implementation or delays to the ongoing trial.

Take advantage of our $1,595.00 price by registering early! * After November 11, costs are $1,795.00.

December 15-16, 2016

Strategic Clinical Research Operational Planning: Applied Techniques for Cost Estimation, Risk Management, and Quality Assurance
San Francisco, CA

This course is an integrative learning experience, combining a comprehensive review of the Good Clinical Practice core principles and project management strategies applicable to clinical research during the new drug development process. We will examine the concepts and applied techniques for cost estimation (PERT analysis, bottom-up, top-down, etc.), risk management, and quality assurance. We will focus on the principles and methodology of planning, controlling, and coordinating individual and group efforts. Key topics include organization strategy and project selection, developing a project plan, scheduling resources, project risk analysis, work breakdown structures, and project networks. Mastery of key tools and concepts introduced in this course and development of the skills vital to effective management of multidisciplinary tasks will provide clinical research professionals a significant competitive advantage in the marketplace.

Take advantage of our $1,595.00 price by registering early! * After November 11, costs are $1,795.00.

December 19-20, 2016

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 $1,595.00 price by registering early! * After November 18, costs are $1,795.00.

December 20-21, 2016

Advanced Post-Marketing Pharmacovigilance Auditing
San Francisco, CA

The European Medicines Agency’s (EMA) post-marketing Pharmacovigilance (PV) regulations known as the EMA PV Modules are designed with the expectation that companies adhere to this new global “gold” standard regarding the receipt, processing, managing, maintenance, and submissions of Adverse Event (AE) data to the relevant health authorities. Not only are these standards applicable to EU-based companies, but any company marketing products (drugs or devices) on a global level. We will review the FDA and EMA expectations, and apply them to the various PV audits.

This course is designed for those that already have some post-marketing PV experience (either experienced auditors or practical hands-on PV staff ). Learners will receive training on how to audit PV at the local level, but to do it with a global perspective. The course will focus on understanding PV agreements, and reporting to health authorities and the relevant auditing mechanisms, including the generation of the annual audit plan based on a risk assessment; generating audit agendas once the plans are put into play; understanding Safety Data Exchange Agreements (SDEA); understanding Periodic Safety Update Reports (PSURs); requesting pre-audit information of PV departments in-house, at a license/marketing partner, vendor, or distributor; and generating the correct categorization of findings for the audit reports.

Take advantage of our $1,595.00 price by registering early! * After November 18, costs are $1,795.00.

December 20-21, 2016

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.

Submissions to a regulatory agency involve more than just writing. They also encompass strategy, editing, publishing and systematic tracking of key information. Through lectures, case studies, and hands-on exercises, new and experienced regulatory professionals learn how to work with the regulations, guidance documents and style guides to produce submissions that comply with the requirements and are clear to the reviewers.

In this practical course, approved drug labels and summary basis of approvals are used to help students acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including pre-marketing (IND), and marketing (NDA/CTD) applications. Participants also gain experience with tools that help manage timelines and sections needed from contributors.

Take advantage of our $1,595.00 price by registering early! * After November 18, costs are $1,795.00.

January

January 24-25, 2017

Conducting Clinical Trials Under ICH GCP
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.

Take advantage of our $1,595.00 price by registering early! * After December 23, costs are $1,795.00.

January 24, 2017

Developing Clinical Study Budgets
San Diego, CA

This course provides the practical skills needed to construct and negotiate study budgets that appropriately compensate investigative sites for resource needs required as a result of clinical research protocols.

Take advantage of our $800.00 price by registering early! * After December 23, costs are $1,000.00.

January 24-25, 2017

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.

Take advantage of our $1,595.00 price by registering early! * After December 23, costs are $1,795.00.

January 30-31, 2017

Optimizing Protocol Design and Strategies to Achieve Efficient, Lower Cost Trial Execution
San Diego, CA

This course will explore the challenges clinical teams face in developing protocols to ensure that the right patients are enrolled and that the right data are collected to demonstrate a drug is safe and efficacious, while at the same time managing study costs and study complexity, especially in trials that involve imaging and interventional procedures. Key factors to consider when developing protocols and techniques to minimize complexity, while at the same time ensuring trial success, will be discussed. This course will also identify pre-award processes and institutional approaches to increasing fiscal return and mitigating fiscal compliance risk for clinical trials. The ability to develop comprehensive budgets and ensure billing compliance for clinical trials is challenging for many clinical sites. Poor financial planning/forecasting and undefined billing compliance practices are associated with increased risk leading to deficits and Office of Inspector General (OIG) investigations. Strategies for covering true costs related to protocol design and multi-disciplinary approaches will be discussed.

Take advantage of our $1,595.00 price by registering early! * After December 23, costs are $1,795.00.