Webinar Replays

Jan 1, 2019 ‐ Dec 31, 2019



Sessions

Webinar Replay: Feasibility Questionnaire Completion: Effective Strategies for Site Success in a Highly Competitive Industry

Dec 19, 2018 3:21pm ‐ Dec 19, 2018 3:21pm
Expiration Date: Jun 20, 2019

Identification: WR07

Credits: None available.

Completing a feasibility questionnaire is something that any successful research site is doing on a consistent basis. The question remains: how does a research site put their best foot forward in an increasingly competitive environment? This webinar will break down the basic and not-so-basic tactics that any motivated site should be practicing in completing feasibilities. Understanding what a sponsor is looking for in an ideal site, leveraging your site’s overall experience and past study metrics, and even when to accept or decline a study and why doing so would be beneficial to your site in the long run are all topics that will be discussed in this webinar.

Learning Objectives

  • Understand what sponsors are looking for in a feasibility questionnaire.
  • Identify strategies to increase a site’s chances of getting awarded a study.
  • Know when and how to convey information to a sponsor that may not be explicitly asked on a feasibility questionnaire.

Speaker(s):

Webinar Replay: Careers in Clinical Development: Working at Syneos Health Japan

Dec 19, 2018 3:21pm ‐ Dec 19, 2018 3:21pm
Expiration Date: Jun 21, 2019

Identification: WR08

Credits: None available.

Primarily for clinicians in Japan and the surrounding region, this webinar presents Syneos Health talent acquisition, leadership and employees who will discuss therapeutic expertise, trial management, and career development within Japan’s first and only biopharmaceutical accelerator. Note that this webinar is in Japanese.

Who should attend?

This webinar is intended for those in Japan and the surrounding regions, interested in entering the clinical research field, as well as experienced professionals looking to expand their expertise in the industry. CRAs/Clinical Monitors, Coordinators, Clinical Project Managers and Project Directors.

This webinar is sponsored by Syneos Health. For more information about careers at Syneos Health, visit: https://www.syneoshealth.com/careers

    Speaker(s):

    Webinar Replay: Waiving or Altering Consent for Minimal Risk Trials

    Dec 19, 2018 3:21pm ‐ Dec 19, 2018 3:21pm
    Expiration Date: Jul 11, 2019

    Identification: WR09

    Credits: None available.

    FDA regulations and the Common Rule share the same definition for “minimal risk,” but while the Common Rule allows a waiver of informed consent for minimal risk research if specific criteria are met current FDA regulations do not.  FDA indicates that waiver of informed consent for certain FDA-regulated minimal risk clinical investigations will facilitate investigators’ ability to conduct studies that may contribute substantially to the development of products to diagnose or treat diseases or conditions, or address unmet medical needs.  FDA intends to revise its informed consent regulations in response the 21st Century Cures Act.  Learn what the FDA is requiring, via recent Guidance in order for minimal risk research to be conducted with an alteration or waiver of informed consent. Be sure you are prepared for the new opportunities this policy change will open to your research teams.

    Learning Objectives

    • Describe existing regulatory exceptions to informed consent.
    • Define minimal risk as it pertains to waiver or alteration of informed consent by the IRB.
    • List the four criteria the IRB must document in order to grant an alteration or waiver of informed consent.

    Speaker(s):
    • Glenda Guest, CCRA, RQAP-GCP, TIACR, President, Assured of Quality Consulting & Training

    Webinar Replay: Consorting with Consortiums: Multi-Centered Trial Management

    Dec 19, 2018 3:21pm ‐ Dec 19, 2018 3:21pm
    Expiration Date: Aug 15, 2019

    Identification: WR11

    Credits: None available.

    Research Consortiums provide opportunities for investigator initiated multi-centered clinical trials. This webinar will consist of a panel of experts providing best practices and the pitfalls of these types of trials from both the lead site and site coordinator perspective. Training coordinators may be difficult since consortium studies rarely have formal investigator meetings or site training. Best practices for training, mentoring and networking that have been successfully implemented will be explored. Data (pre/post survey) from consortium coordinators will be presented and project management checklists will be provided.

    Learning Objectives

    • Describe consortium based research trials from both the lead site and participating site perspective.
    • Differentiate between pharmaceutical trials and consortium research projects and examine key differences.
    • Develop strategies to manage consortium trials by evaluating tools and appraising the evidence regarding coordinator mentoring, training and networking.

    Speaker(s):

    Webinar Replay: Therapeutic Frontiers of Clinical Research

    Dec 19, 2018 3:21pm ‐ Dec 19, 2018 3:21pm

    Identification: WR10

    Credits: None available.

    There are many reasons for the design and conduct of clinical trials. The most recognizable objective of clinical trials is to collect and analyze data to demonstrate safety and efficacy to either gain or maintain regulatory approval for use. There are continual attempts to improve the drug development process by focusing on designing and conducting more fruitful trials that generate superior information on safety and/or efficacy in an ever increasing efficient manner. Such improvements are the logical focus of pharmaceutical industry particularly as technology advances and therapeutic areas of research evolve. Therefore, a better understanding of the costs, efficiencies, and barriers incurred during contemporary drug development process provides both insight and a rational benchmark for the stakeholders involved in various aspects of clinical trial processes. When equipped with these perspectives, clinical research stakeholders may be better equipped to identify opportunities for potential improvements and corrective actions to improve clinical research conduction.

    Learning Objectives

    • Identify barriers and opportunities associated with clinical research of emerging drugs
    • Describe the business and financial aspects of contemporary drug discovery and development
    • Summarize the major therapeutic areas with active clinical investigation

    Speaker(s):

    Webinar Replay: Simplified and Harmonized Studies in the EU

    Dec 19, 2018 3:21pm ‐ Dec 19, 2018 3:21pm
    Expiration Date: Aug 22, 2019

    Identification: WR12

    Credits: None available.

    This course will address the following topics: EU single authorization process for CT applications include two parts for scientific - Part I - and local/ethical considerations - Part II; EU portal will be used for sponsor and EMA/MS communications; Member States and Concerned Member States, CMS, will review responsibilities, submissions and amendments; Investigator/sponsor roles related to CT activities; Key highlights surrounding study management, monitoring and reporting; and Authorization of investigational medicinal products for use in CTs. 

    Learning Objectives

    • Understand Clinical Trial Applications and recognize investigator/sponsor roles related to CT activities.
    • Identify the requirements for conducting clinical trials in the EU and understand expectations for mandatory adherence by trial sponsors to the EU CTR Annexes.
    • Identify key highlights surrounding study management, monitoring and reporting.

    Speaker(s):

    Webinar Replay: INDs and the eCTD Submission Mandate

    Dec 19, 2018 3:21pm ‐ Dec 19, 2018 3:21pm
    Expiration Date: Sep 12, 2019

    Identification: WR13

    Credits: None available.

    This program will introduce attendees to the FDA mandate for all submissions (including commercial INDs) to be provided in the eCTD (electronic Common Technical Document) format. It will review the mandate, terms, terminology, key concepts and steps to enabling the FDA electronic submissions gateway.

    Learning Objectives

    • Understand the FDA mandate for submissions in eCTD format.
    • Comprehend the basics of CTD and eCTD.
    • Understand key terms, terminology and requirements for eCTD.
    • Initiate processes to comply with the eCTD mandate.

    Speaker(s):
    • Jim Nichols, Chief Operations Officer, Cunesoft, Inc.

    Webinar Replay: Is Your Website Making or Breaking Your Business? How to Improve Your Research Site’s Website and Online Presence

    Dec 19, 2018 3:21pm ‐ Dec 19, 2018 3:21pm
    Expiration Date: Sep 19, 2019

    Identification: WR14

    Credits: None available.

    A research site’s website is key to establishing a positive first impression on both patients and sponsors. A website presents an opportunity to convey experience and set a reputable and professional tone. Today more than ever, people search for information about their health online; the quality of a research site’s website could be what draws patients to your site or pushes them away.

    Learning Objectives:

    • Why your research site’s website is so important.
    • What patients and sponsors are looking for in a website.
    • How to make sure your website is making a positive impact on your recruitment efforts, and business overall.

    Speaker(s):

    Webinar Replay: How Can Real World Data Improve the Early Clinical Development Process?

    Dec 19, 2018 3:21pm ‐ Dec 19, 2018 3:21pm
    Expiration Date: Oct 3, 2019

    Identification: WR15

    Credits: None available.

    We will review in detail the types of Real World Data (RWD) sources available in the US, Europe and Asia, both proprietary and government-sourced, that can be leveraged to inform trial design and execution.

    TPPs and CDPs – Country-level incidence/prevalence and treatment rates can now be calculated real-time using a combination of medical claims, EMR, and longitudinal prescription data.

    Addressable patient population for a trial: once a protocol is defined, one can produce attrition tables that can filter these large data sets with the relevant inclusion & exclusion criteria. This can offer an accurate estimate of the likely available patient population for the trial.

    Other insights: RWD can also be leveraged to refine country and site selection. In this presentation, we will provide examples of this type of work in several countries, for several conditions. We will also give some insights on how the regulatory bodies are beginning to accept RWD as evidence in clinical trials.

    Learning Objectives

    • Understand the types of Real World Data available in the US and ex-US
    • Understand how these can be used for the development of TPPs and CDPs, and protocol assessment
    • Understand how these can be used to refine country and site selection

    Speaker(s):
    • Michel Denarie, MBA, Senior Principal, Strategic Drug Development, IQVIA

    Webinar Replay: Attaining the Perfect Balance: Objective Protocol Feasibility Scoring

    Dec 19, 2018 3:21pm ‐ Dec 19, 2018 3:21pm
    Expiration Date: Oct 24, 2019

    Identification: WR16

    Credits: None available.

    Increasing clinical trial complexity with leaner budgets demand the clinical trial site be more agile than ever. Sites must balance needs to effectively staff trials and distribute workload between team members or justify increasing staff to support growing demands. In order to do this, it’s critical to have methods to evaluate, quantify, and document how much effort will be required to execute a project. Protocol scoring or feasibility tools allow objective assessment toward operationalizing a trial and will aid in enhanced justification for protocol acceptance, workload leveling to increase investigation quality and overall participant subject safety.

    Learning Objectives

    • Examine and understand the rationale for detailed protocol analysis to determine decision points for protocol acceptance and more effective workload distribution.
    • Evaluate how feasibility and proactive planning can assist in overall work performance, raising workload quality, enhancing subject safety, and responsible financial management
    • Discuss some of the current feasibility, scoring, and clinical trial tracking tools and their utilities

    Speaker(s):
    • Christina Talley, MS, RAC, CCRP, CCRC, Director, Office of Regulatory Affairs and Translational Management, Houston Methodist Research Institute
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