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Advancing Patient Recruitment & Retention Management in Clinical Trials

One of the biggest reasons to clinical trial program failure is due to inadequate patient enrolment and retention in program’s given time frame. The delay in patient enrolment and retaining enough for a successful trial within in a limited time frame adds unbudgeted costs to the already stressed clinical trial budget. Special populations such as minorities, specific age groups or rare diseases add difficulty to getting recruitment campaigns. Research naïve patients still remain within patient populations make it even more difficult to accomplish enrolment goals for less experienced research sites who usually have access to such groups of patients.   Increasing awareness of the risk profiles in minority populations is an essential step toward improving the identification of high-risk patients who should be candidates for treatment pharmaceutical companies hungry to find new strategies to recruiting and retaining patients impact the success of clinical trials.   This professional training course will show attendees how to advance their current Patient Recruitment campaigns and re-tool their current practices to better deliver within set timelines and better manage patient experience and management of the program itself to effectively bring their clinical trial to success.

Turning 'Theory' into 'Practice'?

This program will combine an overview of the ingredients required to manage and run a successful Patient Recruitment and Retention program that will increase enrollment and retention along with the skills required to implement this approach.

Who should attend?

The attendees will result primary from the following 4 areas: Pharmaceuticals, Medical devices, Biotechnology and Academia. The attendees will be executive or senior-level director with responsibilities or involvement in the following areas: ·Clinical Research, Clinical Development, Clinical Trials, Clinical Operations, Clinical Affairs, Clinical Planning, Clinical Performance, Clinical Study ·Patient Enrolment & Recruitment ·Site Management & Feasibility ·Scientific Affairs ·Project Management ·Ethics & Compliance ·Data Management ·Product Development ·Medical Leader ·Regulatory Affairs / Government Affairs/ Medical Affairs

Key areas to be covered in the programme and documentation

Developing a Strategy by Examining what a Successful Clinical Trial Patient Recruitment and Retention Program Looks Like ·Do a proper Feasibility Study to identify your sites and potential problems ·Design and implement a clinical enrollment plan that best fits your trial needs ·Strategize ways to influencing and build buy-in with key players in the recruitment process ·Build a road map for implementation and integration ·Identify and overcome common recruitment and enrollment management pitfalls  

Determining Patient Recruitment Feasibility ·Understand enrollment challenges of patient populations and motivations to a clinical trial ·“Test” your protocol in the “wilderness” ·Validating successful site and enrolment performances    

Investigate Trending Recruitment/Retention Methods and Techniques to Apply to Your Study Needs ·Identify new channels and tools to advance your recruitment and communications strategies to reach a larger and more specified patient audience ·Tapping into healthcare information systems to identify potential clinical trial patients while notifying relevant nurses and physicians of study eligibility ·Use more modern convenient data collection tools (ePRO) ·Leverage social media and mobile technology best practices to support recruiting & communications ·Using additional channels to increase outreach and interaction  

Understanding Commonly Overlooked Specific Approaches and Considerations to Recruiting Special Populations Including Demographic and Rare Disease Categories ·Understanding the need and feasibility to enact a special populations recruitment plan ·Addressing appropriate timings for specialized populations plans in the US and international locations ·Analyzing industry challenges, incentives and requirements ·Examining current study designs to determine potential for success in special populations  

Increase Patient and Professional Understanding through Program Education ·Increase education and program awareness to site professionals and patients ·Educating and engaging physicians to accelerate patient enrollment ·Outlining a patient experience management strategy to improve retention and keep patients informed and out of the dark ·Communicate and manage expectations of the patient experience for increased ·Strategies to reinforce the value proposition, need and success stories to participating in clinical trials  

Investigating Current Ethical, Safety and Regulatory Considerations ·Understanding operational and ethical concerns with long term trials to demonstrate safety in special populations ·Critical regulatory issues facing clinical trials in special populations ·Navigating requirements to prepare effective trial plans within special populations ·Key timing differences with various pertaining regulatory body requirements

Benefits to you

· Develop an effective recruitment strategy that encompasses innovative methods to reach project goals and integrate protocols · Determine patient recruitment feasibility

· Understand where to plan-out and implement recruitment methods that best meets the study needs · Discover approaches to recruiting special populations: minorities, specific age groups and rare diseases

· Recognize practical and proactive strategies for preventing drop outs or lost to follow up subjects · Incorporate patient experience management ,education plan and technology (ePRO) to improve retention

· Leverage social media and new channel opportunities to promote awareness, communication and enrollment

· Identify and understand methods to overcome common problems to getting programs off the ground · Investigate current ethical, safety and regulatory considerations

· How to reward your best and worst performing sites

· Considerations and questions to ask when to utilize an outsourced approach

Information about the Trainer:  

Vadim Paluy, MD has formal training as a Board Certified Internist with clinical practice and research experience in Russia and the US. Dr. Paluy has over 20 years of clinical research experience including all aspects of project management as well as audit and monitoring international and domestic clinical trials from Phase1 to Phase 3, investigator/patient recruitment, protocol and CRF development, SOP writing, and development of study specific educational materials.

Dr. Paluy has had considerable research interests in multiple therapeutic areas including oncology, infectious diseases, autoimmune disorders, psychiatry and neurology among others. In November 1992 Dr. Paluy founded Placet Research that currently offers consulting services to pharmaceutical, biotechnology, and medical device companies domestically and internationally in the capacity of audit, project management and monitoring. He has very extensive experience working with different types of organizations such as academic institutions (Stanford University), sponsor companies (Merck, Genentech, J&J, BMS, Daiichi, PDL, Telik, Ilypsa, Relypsa, etc) and CROs (ICON, PPD, CSMG, i3Statprobe, Covance, Kendle, Quintiles, MDS, Parexel, ClinStar, PRA International, INC Research, etc).

Dr. Paluy is a frequent guest speaker at conferences and seminars as well as a consultant to Guidepoint Global Advisers, an exclusive community of academic and industry professionals who provide consulting services to the financial industry. In 2004 he was one of co-founders of BIORAMA (Biological Russian-American Association). Dr Paluy was a guest speaker at the Optimizing Patient Enrollment in Clinical Trials Forum (International vs. USA-based CRO's), Annual Clinical Research in Emerging Countries Conferences 2011 as well as MAGI East 2012.

Companies already benefiting include:

Duration of Course

2 Days Day Course

Course details

TBA, 2013

For more information about this course and upcoming course dates, please contact Emily Jones at emilyj@marcusevansch.com or call 312.540.3000 ext 6714

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UK Enquiries: +44 (0) 203 002 3057
or dzingim@marcusevansuk.com

Non-UK Enquiries: +420 (0)2 5570 7246
or training@marcusevanscz.com

North American Enquiries: +1 312 540 3000 X6714 or emilyj@marcusevansch.com




Testimonials

"This course will allow my company to develop its existing strategies to a much greater and hopefully profitable level."

Managing Director, Tarmac