Webinar On Risk Management and Risk Analysis Techniques in Clinical Trials

If you are currently involved in clinical trials either as a CRA, project manager, investigator or sponsor, this seminar will provide you with an overview of risk factors in clinical trials and possible ways to mitigate, control, assess impact, and prevent them in your trial. We would discuss the key elements of risk management such as planning, identification, quantification, action, measurement, outcome assessment, and post-implementation review of various types of risks. Also discussed will be best practices for risk analysis and prospective planning in the project plan. At the end of the seminar, you would be able to review your current project plan for potential issues or help address these factors in the future clinical trial project plans that you may create.  If you are aspiring to be a clinical project manager, are sponsoring a clinical trial, supervise clinical trial operations, or would like to become a clinical site, this course is a must for you.

Managing clinical trials is arguably one of the most difficult jobs in the medical product development industry. Clinical trials are highly complex projects with numerous unpredictable factors that could influence their successful outcome. Several events could adversely affect a clinical trial outcome such as not being able to recruit subjects in a timely manner, managing difficult sites, trial supply issues, biological sample handling, regulatory trouble-shooting, and many more. A key component of clinical project management is the ability to identify potential risks and implementing measures to manage them. This seminar will provide the basics of clinical trial risk management and analysis techniques and practical tips to clinical trial professionals and sponsors using case studies from the presenter’s experiences.

Areas Covered in the Session :

Common risk factors in clinical trials

Retrospective and prospective risk analysis techniques

Risk management: Key techniques in risk reduction, assessment, addressing, training and communication

Risk analysis plan: identification, information gathering, decision, implementation and review

Roles and responsibilities of various personnel in risk reduction

Overview of FDA requirements for risk management                     

Expectations and responsibilities of the clinical project manager

Role of various clinical team members: CRA, coordinators, sponsors and investigators

Challenges of large-scale and international clinical trials

Do’s and Don’ts for risk management of a clinical trial

Who Will Benefit:

Clinical Project Managers

Clinical research associates

Clinical coordinators

Principal Investigators and sub investigators

IRB personnel

Regulatory Vice Presidents, Directors and Managers at sponsors

Attorneys – In-house or Outside Counsel

Price tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299