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 doc ...
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The Indian Wedding Podcast show aims to introduce brides, grooms and their families to exceptional people in the Indian Wedding industry. You will hear leading experts in the Indian Wedding industry who can help you design and execute a dream wedding. You will be inspired by how you to make your wedding unique and meaningful. You'll receive insider tips on photography, wedding planning, catering, jewelry, wardrobe, and much more. No promotions - just value. All our guests are handpicked base ...
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Clinical Trials in Saudi Arabia with Dr. Majed Al Jeraisy
1:15:38
1:15:38
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1:15:38Saudi Arabia’s modern healthcare system, diverse patient population, and research-savvy healthcare professionals make it a great place to conduct clinical trials. To learn more about the clinical trial requirements in Saudi Arabia, I invited Professor Majed Al Jeraisy on the show. Dr. Al Jeraisy is an Associate Professor of Pharmacy Practice, Colle…
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Cardiology Clinical Trials with Dr. Gregg Stone
1:09:14
1:09:14
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1:09:14To learn more about this important field of cardiovascular clinical research, I invited Dr. Gregg Stone on the podcast. Dr. Stone is an Interventional Cardiologist and Director of Academic Affairs for the Mount Sinai Heart Health System and Professor of Medicine (Cardiology) and Professor of Population Health Sciences and Policy at the Icahn School…
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In this episode, you will learn about what type of insurance (if any) is needed to conduct a clinical trial. We also discuss different insurance provisions, choosing the right insurance partner, regulatory requirements that dictate insurance and much more. Dan is a seasoned insurance professional with 10+ years of underwriting and broking experienc…
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How a Wedding Planner Can Save You Time Money with Vidhi Kshatriya
37:28
37:28
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37:28Are you unsure whether you need a wedding planner? Will hiring one be an extra expense, or could it actually help you save time and money? In this insightful podcast episode, we delve into what it truly means to work with a wedding planner and explore the invaluable support they can provide. Our guest today is Vidhi Kshtritye, the founder of The Ma…
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Should you Hire a Bridal Stylist? Expert Advice with Tina Bhardwaj
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43:15
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43:15Have you ever wondered what goes on behind the scenes when you see a picture-perfect, beautifully styled wedding? If so, you’re going to love this interview because we’ll be meeting with a stylist who has years of education and experience styling for events, including weddings. Our guest today is Tina Bhardwaj, a certified fashion designer, wardrob…
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Diabetes Clinical Trials with Dr. Stayce Beck
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17:26
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17:26To learn more about clinical trials in diabetes, I invited Dr. Stayce Beck, Global Vice President of Clinical Affairs at Dexcom Inc. on the podcast. Dr. Beck currently oversees clinical operations, clinical strategy and science, biometrics and human factors at Dexcom Inc, a leading manufacturer of continuous glucose monitors (CGMs) Prior to joining…
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Achieve Unforgettable Wedding Videos with Arina Balerina
43:36
43:36
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43:36Welcome to the Indian Wedding Podcast with your hosts Kunal and Jinal Sampat. In this podcast, we share insider tips for a magical wedding. Arina Balerina, CEO and Videographer of Balerina Films. Arina and her team have been featured in leading fashion and wedding magazines like Vogue, Over the Moon, and many more. Most importantly, her work speaks…
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Access to Novel Medical Products with Dr. Alison Bateman-House
1:13:43
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1:13:43Providing patients access to novel medical products can be challenging to navigate for sponsors and trial participants alike. To learn more about expanded access, compassionate use, Right to Try laws, I invited Dr. Alison Bateman-House, PhD, MPH, MA, an Assistant Professor in the Division of Medical Ethics at NYU Gross…
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Clinical Research as a Profession with Erika Stevens
1:28:35
1:28:35
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1:28:35Unlike an electrical engineer or a plumber, clinical research roles are not explicitly defined or categorized as such, in government employment databases. There are no certification or degree requirements to work as a clinical research professional either. To explore the topic of clinical research as a profession, I invited Erike Stevens on the pod…
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Community Engagement in Clinical Trials with Chris Komelasky
1:20:33
1:20:33
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1:20:33To learn about community engagement in clinical trials, what it means, recent regulations and guidance documents, I invited Chris Komelasky, CEO and Co-founder of SiteBridge Research, on the podcast. SiteBridge Research is an Integrated Research Organization (IRO). Chris and his team help connect physicians and their patients to clinical trials and…
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Community health system-based research with JoAnne Levy
1:32:40
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1:32:40Community health system-based research continues to become an important focus area for pharmaceutical and medical device sponsors given the recent FDA guidance on diversity in clinical trials. Our guest for this episode is JoAnne Levy, Vice President at Mercy Research, a part of Mercyhealth. Mercy Research is one of the largest fully integrated, co…
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Postmarket Surveillance Studies with David Rutledge
1:21:02
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1:21:02In this episode, we’re going to talk about Postmarket Surveillance Studies. In light of the EU Medical Device Regulation (MDR), medical device manufacturers are required to implement a Postmarket Surveillance (PMS) plan, which in turn may require them to conduct Postmarket Surveillance Studies. The importance of such studies has grown in recent yea…
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Human-centered design role in clinical trials with Bruce Hellman and Ben James
1:21:21
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1:21:21In this episode, we explore the role of design in clinical trials. Most clinical research professionals are so focused on protocol design, data collection, and analysis that it’s easy to overlook the importance of well-designed technology that supports clinical trials. One such technology product is electronic Patient Reported Outcomes or ePROs. eP…
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Clinical Trial Site Networks with Christian Burns
1:28:50
1:28:50
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1:28:50There are advantages and disadvantages when it comes to being a standalone clinical trial site. Standalone clinical trial sites enjoy the freedom of running their own operations. But they may face challenges with executing some parts of a clinical trial. This is where site networks come in. For example, a site can run more efficient marketing campa…
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Medical Imaging for Clinical Trial Sites with Kelie Luby
1:22:19
1:22:19
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1:22:19To learn more about site reads and the role of medical imaging software, I invited Kelie Williams Luby, Vice President of Clinical Trials at Mint Medical. Kelie has 24 years of experience as a clinical trial researcher, first as a medicinal chemist, and for the past 19 years as a clinical trialist in medical imaging-based endpoints. She is passiona…
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Risk Management for Clinical Investigators with Bijan Elahi
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1:05:00This is a special episode on risk management. It is important to understand what dictates the work we do as clinical research professionals and how our work fits into the bigger picture of medical product development. This episode serves exactly that purpose. You’ll be introduced to ISO 14971 Application of risk management to medical devices and le…
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5 Strategies for Investigator and Steering Committee Meetings with Kunal Sampat
34:49
34:49
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34:49In this episode, I’m excited to share with you 5 Strategies for planning and conducting investigator and steering committee meetings. Now that the world is starting to re-open after the COVID-19 pandemic, more sponsors are conducting in-person meetings with key opinion leaders (KOLs). These meetings are exceptionally critical to the success of any …
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Clinical Trial Outsourcing with Anca Copaescu
1:00:10
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Complexity in Early Phase Clinical Trials with Dr. Oren Cohen
1:20:24
1:20:24
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1:20:24When a new drug or device undergoes “first in human” experience, the primary focus is on participant safety. How will the drug or device interact with the human body? And will this interaction be safe? To answer these two questions, regulatory authorities around the world require medical product manufacturers to conduct Phase I, also known as early…
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Patient Recruitment in Phase I Studies with Dr. Graham Wood
1:06:51
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1:06:51Phase I trials are generally conducted in healthy participants or in patients with no treatment options such as oncology patients. Unlike late phase trials, Phase I (also known as early phase) studies have different patient recruitment challenges. To learn more, I invited Dr. Graham Wood, Executive Vice President, USA at Nucleus Network. Dr. Wood i…
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Medical Imaging in Clinical Trials with Elizabeth Dalton
1:09:50
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1:09:50Medical Imaging in Clinical Trials with Elizabeth Dalton In this episode, I’m excited to talk about medical imaging in clinical trials. We’ll discuss the role of a medical imaging CRO, imaging endpoints in clinical trials, expensive mistakes to avoid as a trial Sponsor/ CRO, saving money on medical imaging services, imaging data collection process,…
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Clinical Research Data Transparency with Darshan Kulkarni
43:38
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43:38Who owns the clinical trial data generated in industry sponsored or investigator initiated clinical trials? What responsibilities do Sponsors, CROs, or Sites have when it comes to sharing clinical trial results with patients? Should a Sponsor get access to patient data collected outside a clinical trial setting? To answer these questions and more, …
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Launching an NIH Funded Study with Dr. Manish Shah
56:38
56:38
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56:38In the fiscal year 2021, the National Institute of Health (NIH) funded only 16,959 out of 80,878 research project grants. In other words, the success rate was 21%. And the total funding amount was $8,827,444,624. The question I had was, “What does it take to get grant approval and launch an NIH funded research project?” To answer this question, I i…
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Introduction to Coverage Analysis with Kelly Willenberg
54:32
54:32
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Clinical Data Management with Mariam Mirgoli
55:51
55:51
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55:51By Kunal Sampat
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Clinical Research Billing for Small to Medium Sites with Kristi Etchberger
59:17
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59:17A big part of managing clinical research at any site is managing clinical research billing. If you don’t keep track of your research finances, it can end up costing you a lot of money in the long run. To understand clinical research billing, how to manage billing activities, the role of a clinical trial management system (CTMS), differences between…
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Integrating EHR and EDC Systems with Hugh Levaux
1:10:23
1:10:23
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Software Solutions for Clinical Research Sites with Ryan Jones
57:24
57:24
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57:24As the clinical research ecosystem becomes more site and patient centric, I was curious about what an ideal software stack looks like for clinical research sites. It goes without saying you need a laptop and stable internet connection to do business in this day and age. But what else do you need to keep yourself organized as a clinical research sit…
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Indian Pakistani Vegan Wedding with Heer Parikh
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36:02In this episode, we explore what it takes to plan an Indian-Pakistani vegan wedding. Veganism is not a trend or fad. It is here to stay. There are couples who do not want to consume animal products for ethical and health reasons. These couples are bringing their love and passion for vegan lifestyle to their weddings. To learn more about vegan weddi…
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Diversity, Inclusion, and Equity in Clinical Research with Barbara Bierer, M.D.
1:13:57
1:13:57
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1:13:57Dr. 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 a…
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Planning a Wedding in Southern California with Shumaila Panhwar
38:41
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38:41Southern California offers great weather, delicious food, and exceptional venues to plan a magical wedding. In this episode, we invited Shumaila Panwhar from SoCal Event Planners to share her expertise on planning a South Asian wedding in Southern California. Shumalia shares location and multicultural cuisine options, wedding planning tools, why yo…
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Patient Recruitment Failure in Clinical Trials
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42:57This 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…
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Regulatory Affairs for Medical Device Clinical Trials with Priya Jagasia
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44:54
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44:54Clinical 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 woul…
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Decentralized Clinical Trials with Derk Arts
1:09:48
1:09:48
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1:09:48The 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 ove…
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Almost Free Luxury Honeymoon Travel With Trevor Wright
34:51
34:51
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34:51Most couples are excited about their honeymoon travel. It’s something couples look forward to after a busy wedding. A comfortable air travel experience paired with a beautiful and romantic hotel stay can create lasting memories for you and your loved one. But luxury hotels and business class flight expenses can add up quickly to an already expensiv…
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Pre-Wedding Skin Care for Indian Brides with Abhilasha Singh
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28:08We know how important it is for a bride to look and feel fabulous on her wedding day. An important aspect of overall health and well-being for brides is taking care of their skin, which is the largest organ of the human body. To share with you more about pre-wedding skin care, we interviewed Abhilasha Singh, a celebrity makeup and skin artist based…
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Psychedelic Clinical Trials with Rebecca Matthews
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56:12
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56:12My 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 trea…
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Diversity and Inclusion in Clinical Trials with Jennifer Jones-McMeans, Ph.D.
59:50
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59:50Do 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 c…
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Understanding Diamond Quality and Gemstone Certification with Tom Shane
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23:05This episode is a special one. It’s a flashback from our efforts trying to set-up a podcast in 2016. Back then, Jinal and I met the famous Tom Shane from Shane.co at a jewelry conference in Las Vegas. You may have hear Tom’s ads on radio with the tagline “Now you have a friend in the jewelry business” Tom’s speech at one of the conference events wa…
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Clinical Trial Readiness with Joel Selzer
1:00:46
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1:00:46One 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 goi…
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Clinical Research Soft Skills with Ed Hogan
49:42
49:42
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49:42Many 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 P…
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Patient Support Programs in Middle East and North Africa (MENA) with Maha Dakhloul
52:39
52:39
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52:39In 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 …
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Career Development in Clinical Research with Chris Lewis
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42:52
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42:52Starting 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 resear…
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Solving Patient Recruitment Challenges with Maya Zlatanova
44:58
44:58
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44:58I’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 recr…
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Small Intimate Indian Wedding with Nimi Mehta and Prabs Uppal
43:58
43:58
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43:58Planning a Big Fat Indian wedding is one thing. Planning a small intimate wedding with people you love and care about is another. Yes, you can attempt to have the best of both worlds but it’s harder to execute a meaningful wedding with a large guest list. In this episode, we feature a couple who planned and experienced a small, intimate, cross-cult…
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Patient Centricity in Clinical Trials with Craig Lipset
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Jewelry can take many forms. There is fine jewelry made with real diamonds and gold. Then there is costume jewelry made from synthetic gemstones and mixed metal. And then there is floral jewelry made from beautiful flowers. In this episode, we invited Leesha Arora from Prune India to share with us everything families planning for an Indian wedding …
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Planning an Indian wedding is not for the faint heart. Even if you have all the financial resources at your disposal, your wedding partners can elevate your wedding experience. One lesser-known wedding partner is your honeymoon travel advisor. Honeymoon travel planning can be stressful, even if you know how to book flights and hotels with a click o…
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Managing and Communicating Clinical Trial Finances with Blake Peters
57:19
57:19
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57:19Clinical 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,…
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Pre-Wedding Engagement Photoshoot with Peter Nguyen
33:23
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33:23In this episode, LA-based photographer, Peter Nguyen shares with us great insights on pre-wedding photoshoots (also known as engagement photoshoots). You’ll hear Peter talk about his process for choosing a beautiful location and deciding outfits the couple will wear for the photoshoot. We also discuss how storytelling is done for pre-wedding video …
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