Dr. Bierer is the Director of the Regulatory Foundations, Ethics and the Law Program of the Harvard Clinical and Translational Science Center and the Director of Regulatory Policy, SMART IRB.  Previously she served as senior vice president, research, at the Brigham and Women’s Hospital for 11 years, and was the institutional official for human and animal research, for biosafety, and for research integrity.  She initiated the Brigham Research Institute and the Innovation Hub (iHub), a focus for entrepreneurship and innovation. In addition, she was the Founding Director of the Center for Faculty Development and Diversity at the BWH. In addition to her academic responsibilities, she currently serves on the Board of Directors of Vivli, Inc., a non-profit organization founded by the MRCT Center dedicated to global clinical trial sharing; Management Sciences for Health (MSH), an international organization working in partnership globally to strengthen health care, local capability, and access; and the Edward P Evans Foundation, a foundation supporting biomedical research.  Previously she has served as the chair of the Board of Directors of the Association for Accreditation of Human Research Protection Programs (AAHRPP), on the Board of Public Responsibility in Medicine and Research (PRIM&R), and as chair of the Secretary’s Advisory Committee on Human Research Protections, HHS. She has authored or co-authored over 240 publications and has served on the editorial boards of a number of journals including Current Protocols of Immunology, Blood, Therapeutic Innovation and Regulatory Science, Ethics and Human Research. Dr. Bierer received a B.S. from Yale University and an M.D. from Harvard Medical School. Please join me in welcoming Dr. Barbara Bierer on the Clinical Trial Podcast.  This episode is brought to you by Florence Healthcare. To learn more, visit https://florencehc.com/

Clinical Trial Podcast | Conversations with Clinical Research Experts

Diversity, Inclusion, and Equity in Clinical Research with Barbara Bierer, M.D.

This podcast episode highlights the top reasons for patient recruitment failure in clinical trials from an investigator perspective.   The podcast episode will help you understand how Sponsor and CRO personnel including software vendors can best support investigators meet or exceed their patient recruitment.    The goal is to bring more awareness on how to prevent patient recruitment failure and complete enrollment as planned.   Initial funding insufficient to reimburse recruiting staff/sites Context-specific logistic obstacles (e.g., urgent transfers from intensive care, different treatment availabilities at different centers or on weekends) Lack of methodological/logistical support (e.g., from contract research organization or clinical trial unit) Prejudice against effectiveness of trial interventions  New evidence from other study about effectiveness of trial interventions Administrative burden/time constraints  Lack of eligible participants - Overestimated prevalence (mostly reported as overly narrow eligibility criteria) Concurrent competing trials High burden (e.g., many visits, invasive procedure, questionnaires, costs)  To learn more and get detailed show notes, visit clinicaltrialpodcast.com Podcast Sponsor: This episode is brought to you by Florence Healthcare. 

Patient Recruitment Failure in Clinical Trials

Clinical trials are conducted in compliance with regulations.  Simply stated, you need a clinical and regulatory strategy when it comes to conduct of clinical trials for medical devices. As a clinical researcher, there have been times I’ve felt lost because I did not understand the regulatory framework. To close this knowledge gap, I thought it would be great to invite Priya Jagasia, Divisional Vice President (DVP) of Regulatory Affairs at Abbott Vascular on the show. In this episode, Priya shares with us her experience and knowledge on regulatory affairs, specifically focused around medical device regulations in the United States. She does a great job of tailoring our conversation to make it applicable for clinical trial professionals. We cover topics such as working with the FDA, partnership between regulatory affairs and clinical research, career and professional development, and much more. The art and science of regulatory affairs is fascinating and there is no better person on the planet who can educate us on this topic. Please join me in welcoming Priya Jagasia on the Clinical Trial Podcast. Podcast Sponsor: This episode is brought to you by Florence Healthcare. To learn more, visit florencehc.com

Regulatory Affairs for Medical Device Clinical Trials with Priya Jagasia

The pandemic has helped fast track the adoption of technology in clinical research. This has been a much needed change and we’re headed in the right direction.  The change in turn has led to an increased focus on decentralized clinical trials (DCTs).  But what exactly is a DCT?  To learn more, I invited Derk Arts, Founder & CEO of Castor.  Derk has over fifteen years of experience in medicine, research and technology.  His company, Castor, provides useful technology for sponsors and sites to conduct decentralized clinical trials.  What is great about Derk is that he is a physician by training and now runs a clinical trial software company.  At a micro level, Derk understands the tools a doctor needs to provide optimal patient care in a clinical trial setting.  At a macro level, Derk can see what it takes to conduct a clinical trial with multiple sites/ patients and how technology can solve such complex problems.  This was a fun interview for many reasons.  Derk talks about the future of Electronic Data Capture (EDC), his thoughts on what it means to run a decentralized clinical trial, most misunderstood aspects of DCTs, Castor’s company culture, his favorite books, honey bees, and much more.  I hope you enjoy this conversation with the all amazing Derk Arts on the Clinical Trial Podcast. This podcast is brought to you by Florence Healthcare. To learn more, visit https://florencehc.com/.  

Decentralized Clinical Trials with Derk Arts

My guest for this interview is Rebecca Matthews, Chief Clinical Operations Officer at Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corporation. In this interview, Rebecca shares with us what it takes to conduct clinical trials investigating the use of MDMA, a psychedelic drug, in conjunction with psychotherapy to treat patients with post traumatic stress disorder (PTSD). PTSD can occur after a person experiences a significant trauma, like a sexual assault, severe physical assault, significant threat to life arising from a hate crime, natural disaster, war, or accident. It affects people of all races, ages, and backgrounds.  As you’ll hear from Rebecca shortly, the clinical data from the recent clinical trial looks extremely promising.  This interview will leave you with excellent insights on differences and challenges of conducting research with psychedelic drugs including site selection, patient recruitment, clinical trial design considerations and more.  I am beyond excited to discuss this important topic of psychedelic research on the podcast.  Please join me in welcoming Rebecca Matthews on the Clinical Trial Podcast. Enjoy! Podcast Sponsor This interview you brought you Florence Healthcare. Transform your Clinical Trials with the #1 Platform for Electronic Document Workflows and Remote Site Access. Learn how Florence Healthcare helps over 7,200 research sites, sponsors, and CROs across 27 countries take their day back from paper.

Psychedelic Clinical Trials with Rebecca Matthews

Do you want to enroll a diverse patient population in your clinical trial?  Are you a sponsor looking to develop a solid clinical trial strategy? Are you looking to develop foundational skills as a clinical research scientist? If you answered “Yes” to any of these questions, then this interview with Jennifer Jones-McMeans will serve you well. Jenn currently serves as the Program Director for cardiovascular studies at Abbott Medical Devices.  She has played a key scientific role in some of the largest drug eluting stent clinical trials from trial design to publications and presentations.  It’s because of Jenn’s direct contributions as a scientist and scientific program director, many cardiology medical devices received FDA PMA approval or 510(K) clearance.  Most recently, Jenn has been involved in Abbott’s efforts in designing studies that include a diverse group of underserved clinical trial participants.  As an African American woman, mother, and wife, she is an inspiration and role model for women interested in developing their career in clinical research.  My interview with Jenn touches on a variety of topics including diversity and inclusion in clinical trials, developing a clinical trial strategy, working with key opinion leaders, skills you need to grow your career as a clinical scientist, and much more. I hope you enjoy my interview with Jennifer Jones-McMeans on the Clinical Trial Podcast.

Diversity and Inclusion in Clinical Trials with Jennifer Jones-McMeans, Ph.D.

One of the biggest challenges in clinical study start-up and conduct is “training.” A few factors that impact training include the clinical site personnel’s ability to retain and understand key study information, staff turnover at the site, individual learning style and preferences and much more.  With many clinical research and trial activities going virtual, having an online platform to train research staff on the protocol and trial operations is useful and necessary. In this podcast interview, I speak with Joel Selzer, CEO & co-founder of ArcheMedx. Joel shares with us how the ArcheMedx team is using technology and behavioral science to improve clinical trial operations with a focus on study training. We also discuss the importance of adequately preparing sites and site personnel to conduct a clinical study, how sponsors and CROs can effectively deliver study content and much more. I hope you enjoy my conversation with Joel Selzer on Clinical Trial Readiness.   

Clinical Trial Readiness with Joel Selzer

Many people tout about technical skills in clinical research. You need to know Microsoft Excel. You need to understand Good Clinical Practice. You need to memorize the FDA guidance documents. Have you ever heard someone talk about soft skills in clinical research? I realized the importance of soft skills after joining Abbott in 2007 as a Clinical Project Manager. When you work with a diverse team, you must master soft skills. Soft skills, also known as “real skills”, help you learn, adapt and grow.  In this interview, I invited Ed Hogan, Executive Vice President (EVP) at Invicro, to talk about soft skills in clinical research. Ed and I first met in 2005. He was the Director for Medical Imaging at PAREXEL/ Perceptive Informatics, my first job out of college. Ed is now responsible for overseeing the clinical services team which includes project management, imaging services, data management and reader management for early and late phase clinical trials. Ed has close to three decades of experience in clinical research, managing, and executing Phase I through Phase IV imaging trials in both the Pharmaceutical and CRO space.  He is THE expert when it comes to medical imaging operations. Ed has progressive business experience in building and managing global cross-functional teams supporting clinical trials focusing teams on delivery, accountability, and customer satisfaction while driving quality and process improvements. For these reasons, I invited Ed to talk to us about soft skills including negotiating contracts, how to develop a successful manager-employee relationship, what Ed looks for when he is wanting to promote someone on his team, leading effective meetings and much more.  I hope you enjoy my conversation with Ed to the Clinical Trial Podcast [3:50] Soft skills and project management [4:54] Negotiating contracts with Sponsor including cost, study design, and operations [7:25] Offer Sponsors what they need and not nice-to-have elements  [8:24] Clinical project managers are involved in finances   [10:22] Ideally Sponsor should ideally have a direct communication with imaging CRO [11:59] Example of risk mitigation in clinical trials  [13:39] Developing soft skills through PMP certification and courses and on the job training [14:45] Managing and working with project team members [17:21] Developing a strong team with diverse and complementary skills [19:01] Putting in time and practice to develop your skills [21:01] Soft skills are not easy to do [22:28] Key ingredients that make a successful manager-employee relationship [23:52] Giving direct and timely feedback  [25:37] Feedback “sandwich” [26:32]  Managers can plan and prepare before giving feedback. (a) State the outcome, (b) state the issue, (c) listen, (d) reinforce your intent to help, (e) repeat the end goal and expected outcome, (f) followup with an email [28:51] Practical advice on managing up [31:54] Giving and getting feedback from your colleagues  [34:06] Developing writing skills [36:01] Understand pain points to create winning proposals [37:23] Finance skills such as dealing with budgets, ability to write and communicate effectively, multitasking, time management, learning styles are some of the skills Ed focuses on when  promoting or hiring someone new [40:41] Getting your foot in the door with entry level clinical research roles  [45:54] Dealing with emotional employees when giving feedback    Resources Mentioned: Never Split the Difference with Chris Voss Project Management Professional (PMP) curriculum Radical Candor by Kim Scott StrengthsFinder 2.0 by Gallup (Author) The Five Dysfunctions of a Team: A Leadership Fable by Patrick Lencioni Myers Briggs Personality Test Official Microsoft Excel Video Training The 7 Habits of Highly Effective People by Stephen R. Covey Harvard Business Review for managers Atomic Habits: An Easy & Proven Way to Build Good Habits & Break Bad Ones by James Clear James Clear’s newsletter

Clinical Research Soft Skills with Ed Hogan

In this episode, I had an opportunity to speak with Maha Dakhloul on the topic of Patient Support Programs (PSPs) in the Middle East and North Africa (MENA region). Maha does a great job of explaining with us how PSPs are set-up, how one can develop a PSP, the lesser known components of a PSP, how to measure a successful PSP, how to evaluate a PSP provider, the interdependence of clinical trials and PSPs in the MENA region and much more. This interview was recorded shortly after the explosion in Beirut in August 2020. I’d like to thank Maha for taking the time to chat even though her city was experiencing such pain. Maha has a bachelor’s degree from the Arab University of Beirut. She has worked as Clinical Research Coordinator, Clinical Research Associate, Regulatory Affairs Manager, Clinical Project Manager and is currently the Clinical Operations Manager at Phoenix Clinical Research . Please join me in welcoming Maha on the Clinical Trial Podcast. Maha Dakhloul on LinkedIn

Patient Support Programs in Middle East and North Africa (MENA) with Maha Dakhloul

Starting a career in clinical research with little or no experience can be difficult. Equally challenging is for hiring managers to find candidates that are a cultural fit for the organization. In this interview, I invited my close friend and mentor Chris Lewis to talk about his process of attracting, hiring, and retaining talent in clinical research.  We talked about the future of the CRA role and what skills are needed to succeed in today’s marketplace.   Chris has over 20 years’ experience leading teams and managing clinical trials in the medical device, biotech, and pharma industry.   At IntersectENT, he serves as Vice President, Clinical and is responsible for developing and managing clinical programs.   Chris graduated from the University of Louisiana, where he received his Bachelor's degree in Biology and an M.S. degree from George Washington University. During his spare time, Chris enjoys vacationing in our national parks with his family, trail running, camping, and pretty much every other outdoor activity under the sun. Please join me in welcoming Chris Lewis on the Clinical Trial Podcast.  Chris Lewis on LinkedIn Trainual software for onboarding and SOP training How to Win Friends and Influence People by Dale Carnegie Good to Great: Why Some Companies Make the Leap and Others Don't by Jim Collins Show notes: 1:52 Chris unconventional path to clinical research career  2:38 Journey from research coordinator to vice president  3:18 Impact of rise in technology, remote monitoring and risk based monitoring on the CRA’s role 5:49 Who is responsible for proctoring clinical trial cases? CRA or Field Clinical Engineer (FCE) 6:49 Importance of relationship management, technical expertise, problem solving skills and staying calm in the operating room   8:05 Building interpersonal skills through partnership and collaboration 9:34 Consolidation of electronic systems and access to sites  12:25 Process of hiring, interviewing and finding right talent 14:31 Leveraging social media (LinkedIn) and internal human resources systems for hiring 16:12 Getting to know someone through their hobbies, mannerisms, eager to learn, work hard, and ability to getting along with the rest of the team 18:03 The importance and process for having difficult conversations   22:53 Getting the new job posted  Creating clear job description Making a request for requisition Getting it approved through HR and executive 23:29 Making an offer Confirm with HR is the requisition is still valid  Obtain executive approval stage Clean communication between the candidate and hiring manager throughout the process  25:58 Onboarding new employees needs to be planned  Create an onboarding plan Clearly articulate and set expectations Training Plan Assign a mentor/ buddy (not their manager) Weekly meetings  Access to systems 28:34 Providing ongoing leadership and management  32:33 Core skills i.e. soft skills needed for a  clinical research professionals How to get along with people and see their viewpoints  How to manage a challenging situation 36:30 You don’t need two years of experience to get a job in clinical research  38:03 Getting into clinical research career with no experience Getting a masters degree in clinical research  Making contacts and exploring LinkedIn 39:19 How does living on the farm impact Chris’s life at work ? 41:00 Take control of your career, have patience, get your manager to understand your career aspirations Resources Mentioned Abbott Trianual - software solution for onboarding and SOPs [Book] The 7 Habits of Highly Effective People by Stephen Covey [Book] Good to Great by Jim Collins The Clinical Research Administration Program at George Washington University  

Career Development in Clinical Research with Chris Lewis

I’m always excited to speak with software entrepreneurs in clinical research and this episode is no excpetion. Our guest on today’s show is Maya Zlatanova, CEO of FindMeCure.  Maya and her team are creating a “google” for clinical trials.  She is on a mission to make it easy for patients to find ongoing clinical trials She wants to solve patient recruitment challenges enabling patients and doctors to connect with each other She believes in the power of stories, not just facts, something unheard of (but much needed) in clinical research. FindMeCure is dedicated to simplifying the patients' journey while volunteering for a clinical trial while helping the industry plan their trials with the full picture of country capacity, sites' experience and patients needs and journey. Maya is a healthtech entrepreneur, clinical research expert, and pharma industry speaker with over 15 years of global experience in clinical research regulations, patient recruitment, and engagement, clinical trial feasibility, and operations.  Maya’s strongest skill is empathy.  Her principles in life are to be trustworthy, care for other people and give first.  She also cherishes her never-ending curiosity about how life and the universe work, how to improve ourselves and our environment.  Please join me in welcoming Maya Zlatanova on the Clinical Trial Podcast. [2:25] About Maya’s company FindMeCure, Maya’s experience working on clinical research software for the British government and first online GCP training [4:14] Maya’s sister was diagnosed with an eating disorder and struggled to find treatment. This let to Maya looking at clinical trials from a patient perspective [6:06] Creating a global platform for patients to find out about alternative treatments in clinical trial setting [8:29] Connecting patients in one country with clinical trials in another country [9:55] Challenges for patients include: Human factors such as need to be close to family Traveling long distances to participate in clinical trials Being treated by different doctor (trial investigator) than their primary physician  [13:01] Patient recruitment process can benefit from change. Currently we first select sites and then bring patients into these sites [14:26] We need to break things to innovate [15:25] In an ideal world, we would have a centralized electronic health record, we know where patients are, patients are monitored with telehealth solutions, central site that is leading other sites  [16:55] Everyone wants to go to the experienced sites [19:43] Hybrid clinical trials [20:28] Need to support sites and investigators by questioning what sites should and shouldn’t do [24:05] convincing decision makers to select sites in other geographies using financial metrics [28:03] Language is not an obstacle at most sites. Ethical considerations can pose an issue.  CRO with local office  Site Management Organization (SMO) Own CRA networks [32:00] Adoption of technology in clinical research such as sites being open to new remote solutions [33:35] Whatever works for clinical research will work for the healthcare sector [34:03] ACRES helping sites getting accredited and certified if they follow certain standards for clinical trials [36:32] GCP is the only standard in clinical research. For example, it is not sufficient for patient centric trials [38:02] Need to align on initiatives such as patient engagement guidelines in EU and USA [39:45] Empathy is a feeling for people and imagining yourself in their shoes. Being open to the fact that you could be wrong. Listening to people, hearing you are wrong, and converting to the right thing [42:42] Maya’s secret weapon is speaking with different people with different backgrounds to learn and grow Resources mentioned: Society of Clinical Research Sites (SCRS) Association of Clinical Research Professionals (ACRP) Food and Drug Administration (FDA) Alliance for Clinical Research Excellence and Safety (ACRES) TransCelerate - Pharmaceutical Research and Development Pharmaceuticals and Medical Devices Agency (PMDA) EUPATI: Patient Engagement Through Education - EUPATI  

Solving Patient Recruitment Challenges with Maya Zlatanova

Patient Centricity in Clinical Trials with Craig Lipset

Clinical trial finance is a key area of clinical trials and clinical research.  Human beings are innately not good with numbers and clinical trial finance is no exception.  Creating study budgets, forecasting clinical trial costs, and managing trial finances are essential skills for any clinical research professional.  This is true for sites, vendors, CROs, and Sponsor personnel, irrespective of whether they have direct responsibility for clinical trial finances.  In this episode, I had the opportunity to speak with my friend Blake Peters who is exceptional at what he does with clinical trial finances.   Blake is currently an Associate Director, Clinical Research at Abbot Labs.   I’m excited to bring Blake on the show given his extensive experience managing multi-million dollar clinical trial budgets.  We had an excellent conversation on a variety of topics such as careers, being resourceful, clinical trial finance, storytelling and presentation skills, and much more.  I hope you enjoy this interview with Blake.  Blake Peters on LinkedIn. How does one make a transition into clinical research? Core skills Bringing value to your team Helping clinical project managers forecast and estimate clinical trial costs Excel skills Data analytics Financial mindset Continued curiosity to learn and grow Transitioning from finance to clinical research  Learning about the conduct of clinical trials Therapeutic knowledge On the job training A clinical research training conference Working with clinical project manager on finances  Challenging clinical trial assumptions to optimize financing Historic data on benchmarking Hospitals are required to publish procedure costs Collaboration with finance on clinical trials and research Alignment on vocabulary, a common understanding of what each if try to talk about Maslow’s Law of Hierarchy for Clinical Trial Costs  Cost of the clinical trial - a list of expense type Cost driver - how to multiply the expense, scales with sites and/or patients or fixed expenses Timing of these expenses  Factors that change the cost Total trial cost  Clinical Research Organization (CRO) budget - ensuring you are not overspending when you decide to outsource Review project management fees Review monitoring costs Categorize costs into buckets or functional costs (safety, data management, operations, etc.) Becoming proficient in Microsoft Excel  What do you find yourself doing manually and/or repeatedly? Be resourceful Spending 5-10 minutes can save you tens or hundreds of hours Research solutions (Youtube, Google) and implement Powerpoint skills in clinical research  Understanding the message Meeting with the stakeholders Think about table vs. graphs vs. graphics Don’t overdo animations First, get the content on the slide and then focus on the aesthetics of your slides Iterate, hit save and look at it again the next morning Types of PowerPoint slides Speak for itself with clean design Reference manual  Different audience/ use cases Slides are an outward representation of the person who built them. They serve as an opportunity to show your creativity and can open doors for you Valuable skills for clinical research professionals Listening Public speaking/ storytelling Passion and inspiration Managing stress with diet, meditation, drinking a lot of water  Resources mentioned: Abbott What Got You Here Won't Get You There: How Successful People Become Even More Successful by Marshall Goldsmith

Managing and Communicating Clinical Trial Finances with Blake Peters

Today we’re in the midst of the pandemic and virtual clinical trials are likely going to be a big part of our post-COVID-19 world.  In this interview, I had the pleasure of speaking with Mike Novotny about virtual trials i.e. decentralized trials.  Mike is the founder and CEO of Medrio. Mikes brings over 20 years of experience in research and software to his eClinical SaaS vision.  Prior to founding Medrio, Mike was president of Ninaza, an EDC software company, and had previously held roles as a research associate at the U.N. and a manager of the fraud database at VISA.  He holds a BA from Stanford University and an MBA from Columbia University. Mike founded Medrio in 2005 in San Francisco. I hope you enjoy my conversation with Mike. What is a decentralized or virtual clinical trial?  Benefits of a virtual clinical trial in patient recruitment The current model of clinical trials where recruitment is done through the doctor What does it mean to conduct a decentralized or virtual clinical trial? Case Study - CNS trials and how they can benefit from going virtual A limited number of patients (smaller patient pool)  Use of social media to find eligible patients The patient does not need to travel to the doctor’s office, the caregiver goes to the patients home Medrio as a technology provider for virtual studies  eConsent Electronic data capture (EDC) Direct Data Capture (DDC) Randomization with EDC  Case Study - Cholera vaccine study in Yemen Collecting clinical data without an internet connection The downside of paper data collection DDC is a subset of eSource eSource can be EHR, DDC, ePRO, eCOA Future of EDC as we get more integrated with EHR Patient recruitment New efforts through AI Efforts through social media Genetic profiling Enabling participants to be anywhere in the world to participate in the trial Barriers to adoption Importance of monitoring in a virtual clinical trial to prevent fraud  The downside of a virtual clinical trial is the implementation Patients want their doctor to be involved New tools lead to new complications The trial does not match the decentralized model Common concerns from Sponsors Storing data on the cloud is risky Offline data management - what if the wifi goes down or there is no cellular signal Data loss - what if the tablet break Thinking in terms of relative risk Clinical trials fail 90% of the time Trial data is never looked at again Need to standardize audits to bring the cost down and improving the quality of the audit Medrio is focused on:  Speed Great tool for early phase diagnostic and device studies Customer service measured using net promoter scores eSource - Direct Data Capture (DDC) Optimism, focusing on the positive, not watching/ reading the news 

Virtual Clinical Trials with Mike Novotny

In this interview, I had the opportunity to speak with Ahmed Hamouda.  Ahmed is the Head of Clinical Operations at RAY-CRO in Egypt and a certified clinical research professional with more than 10 years of experience within the clinical research field. I’ve been intrigued and fascinated by the Middle East and have wondered how trials are conducted in the region.  If you’ve been site and country selection meetings trying to determine whether you want to conduct trials in Egypt but have more questions than answers, this interview is for you.  You’ll hear Ahmed breakdown the exact clinical trial conduct process in Egypt step-by-step. Ahmed has worked in a wide variety of professional capacities over different regions and markets in the Middle East, Gulf, Europe, and Asia. He is a pharmacist by education and received his MBA in 2013. Aside from being a clinical research professional, Ahmed likes to dive and explore new cultures. Show Notes: Ahmed Hamouda on LinkedIn Ahmed’s background and experience working in the Middle East  Value of conducting trials in the Middle East A large population of over 300 million people 21 countries in the region Prevalence of diseases such as cardiovascular and hypertension Reasons why some Sponsors and CROs are not doing research in Egypt Lack of awareness of Egypt’s capabilities  Long approval times for exporting blood samples  Importation process for medical products in Egypt Certificate of Analysis and quality documents Site Start-up Process Select sites Secure IRB approval (~1 month) Ministry of Health Approval i.e. MoH (~2 months) Observational trials can start right away Interventional trials require additional review (see below) Interventional trials (~2 months) Biological are submitted to The National Organization for Research and Control of Biologicals (NORCB) Non-biological are submitted to The National Organization for Drug Control and Research (NODCAR) Importing investigational medical product (IMP) Central Administration of Pharmaceutical Affairs (CAPA) Role of MoH vs. NORCB/ NORDCAR MoH will review study-specific documents such as protocol, eCRFs, CVS, patient-facing materials, insurance, patient diaries, signed contracts, etc. NORCD/ NODCAR will review information specific to the investigational product Process for adding more sites midway through the study Trial classification in Egypt - Phase I, II, III IRB rejections (decline) and how they are managed Product approval and commercialization  The concept around open-box vs. close box Pricing file is the limiting factor Naming list Pharmacovigilance (PV) files Contracts and Budgets Required at the time of IRB and/or MoH submission  Exceptions are handled via Sponsor/ CRO generated commitment letters Clinical Trial Research Units in Egypt  Allocation of budget and distribution between the site and the investigator Use of clinical trial contract templates  Contracts are in English and Arabic High-quality translations are achieved with the help of medically trained and certified translation company Site selection process  Lack of computerized system at the site can cause issues Career advancement for clinical research professionals in Egypt Social responsibility on part of CRO Other Resources: RAY CRO Pharma Med, a medical translation company ICH GCP Guidelines 

Conducting Clinical Research in Egypt with Ahmed Hamouda

Clinical research and clinical trial management form the backbone of drug and device approvals worldwide. Learn from the leading industry experts to build and advance your clinical research career. You'll hear from sponsors, clinical research organizations, and clinical trial sites around the globe. This show is for all current and aspiring clinical research professionals including clinical research associates (CRA), clinical operations managers, study managers, biostatisticians, medical doctors, safety monitors, clinical scientists and other healthcare professionals.

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Clinical Trial Podcast | Conversations with Clinical Researc...

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