Effective Strategies for Successful Remote Monitoring of Clinical Studies
Why this training?
It has been just over 2 years since novel coronavirus came & disrupted our lives. Interestingly disruption fuelled many new strategies to do conventional work remotely. Although remote monitoring of clinical trial existed in theory for many years now, but its become a adopted practice by many sponsors, CRO after the onset of coronavirus. Moving forward, we will see remote monitoring as a part of successful strategy for managing clinical trials. This training will focus on different tips and strategies of successful remote munitioning of clinical trials.
Mode of training : Online LIVE (Using Teams platform)
Course Fee : 250 USD ( for participants registering from outside India)
8000 INR (for participants registering from India)
( including complete training material and certificate)
Course Agenda :
Fundamentals of De-centralized Trials
Day 2 & Day 3
Risk based remote monitoring planning & implementation
Technologies for virtual risk based monitoring and De-centralized trials
Q & A session
Training will focus on group discussion, case studies etc.
Trainer's Profile : Bhumi Vyas
Bhumi Vyas is a qualified QA professional with 17 + years of experience in the field of Pharmaceutical, Biotechnology & Clinical Research industry making a difference in the organizations by initiating the new era of linking technology with research science.
Significant & Successful track record in establishing & implementing Quality Management System. Having wide range of experience in performing and managing clinical & analytical audit program and ensuring compliance to US FDA Code of Federal Regulations (CFR), EU, ICH GCP and global regulatory requirements. In depth analysis with solutions of CAPA systems, investigations & root cause analysis.
Successfully handled regulatory inspections (and has lead inspection readiness program) from DCGI – India, UK MHRA, US FDA, EMA, Thailand-MoH, Turkey-MoH, ANVISA – Brazil, WHO, MCC – South Africa and Kazakhstan – MoH.
Past Training Feedback on the same topic :
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GCP: Project Management during these challenging period
Project management is crucial for success of any research projects and especially when they are in healthcare. Managing the projects within the framework of guidelines, regulations and compliance needs meticulous planning and through understanding. The challenges are many and current worldwide situation is test of our skills and knowledge. New insights with changing times always help. Get yourself ready for the new NORMAL of the project management.
This training will help you assess understanding the crucial issues, the roles and responsibilities and the effectiveness of the monitoring process. It will help you devise new strategies for remote monitoring with identifying and flagging the key areas for corrective measures. Afterall, each step is important and must be executed meticulously.
Date : 28th, 29th and 30th September, 2020
Duration : 7.5 hours
Time : 5 pm to 7.30 pm IST (7.30am to 10am Eastern time)
Mode of training : Online LIVE (Using Zoom platform)
Course Fee : 95 USD or 6500 INR ( including complete training material and certificate)
Course Content :
Key aspects of project management as per GCP
2. Challenges in conducting clinical trials
3. Emerging additional challenges during the pandemic and lock-downs
4. Identifying the key problem areas
5. Finding innovative solutions
6. Tools for effectiveness
7. Key learnings
Trainer's Profile : Dr. Manjusha Rajarshi, Ph.D
Dr Manjusha Rajarshi has got more than 25 years of working experience in the pharmaceutical industry. She was working with multiple pharma companies in the past like Serdia, Bayer, Aventis Pasteur, Unichem, B. Braun. She had adopted multiple roles in the past, her career moved from training department to medical department to clinical operations and regulatory affairs and medical affairs.
Dr Majusha holds master degree in pharmaceutical science from University of Mumbai and PhD in Pharmacology from University of A.M. Kolkata. She has more than 25 publications in various journals like American Journal of Cardiovascular Drugs, Neurology, International Journal of Cardiology, Diabetes Research etc. She is now a consultant & trainer in the area of regulatory affairs, clinical research, Medical writing, audits and compliance.
Feedback of previous same training :
All went well. learned a lot and the course met my expectation" - Olebogeng Jokane; Project Manager, The Aurum Institute
"Presenter was subject matter expert. Examples were relevant to the industry of clinical research. Throughly enjoyed this training."- Giuseppe de Gouveia, Clinical Operation manager, University of Cape Town
"Very high standard. Really helped with equipping me to manage project better going forward. Helped to identify weak links and how to improve. Looking forward to going back to work and implementing."- Dr Sharon Booysen, Medical Officer-Sub Investigator, Perinatal HIV Research Unit
"Presentation was well planned and the faculty have ensured that participants are all actively involved."- Selomang Malepe, CRA, PRA International
Topic : Remote Monitoring during clinical trial : a risk based approach
With the global COVID-19 pandemic, sponsors and sites are faced with circumstances that may slow clinical research. Travel restrictions have made it difficult for subjects to get to sites for their study visits. CRAs too are unable to conduct onsite monitoring visits. As a result, sponsors are exploring remote monitoring solutions.
This course looks at implementing the shift from traditional monitoring to remote monitoring and how these visits may be conducted in the changing environment. It includes reassessing ways to collaborate virtually with sites and completing the report.
Date : 21st and 22nd July, 20 20
Duration : 4 hours
Time : 6 pm to 8pm IST (8.30am to 10.30am Eastern time)
Mode of training : Online LIVE
Course Fee : 45 USD or 3000 INR ( including complete training material and certificate)
1. Introduction to Remote Monitoring
2. Planning a Remote Monitoring Visit
3. Conducting a Remote Monitoring Visit
4. Report and Follow-up
Trainer's Profile :
Suheila Abdul-Karrim is an independent clinical research consultant providing services & training to Pharma, CRO and Medical Institute. Based in Johannesburg, she has got over 21 years of clinical trial experience as clinical research manager, GCP trainer & auditor. She is currently the Vice-Chair of ACRP Professional Development Committee. She travels extensively to Africa, Asia, India, USA & Europe for training & auditing activities.
Please send the filled up registration form to firstname.lastname@example.org to register and call us at +91 804169 2453 / +91 9945318216 for any query or registration help.