Trials with Maya Z

In this episode, Maya meets Colin Sholes. Colin is the founder of Cure Clinical Inc., a US-based software company building a comprehensive database for clinical research performance analysis.

Maya and discuss the following topics:

(4:29) Why is a direct-to-consumer business similar to patient recruitment

(8:06) How to balance the pitch to patients with the site demands

(11:23) How to achieve consistency in patient recruitment ads

(14:40) Are sponsors and CROs reacting to clinical sites direct feedback

(16:58) How does Cure Clinical make trials more scalable

(20:50) Do sites need better statistics or better tools

(24:00) The #1 solution to make trials more patient-friendly

Tune in today for a thrilling journey into the world of clinical trials – expand your knowledge! 

Maya Zlatanova, CEO of Trialhub

Colin Sholes, Founder of Cure Clinical

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Cure Clinical

In this episode, Maya meets David Rosenbaum to talk about immigrants in clinical trials. David helps scatter the immigrant bias with clinical trials in Turkey and other Balkan countries. However, it’s an ongoing administrative effort. 

David is the Founder of Rosenbaum Group. It is a CRO operating since 2019 in the south-eastern Balkans and Turkey. The organization focuses on clinical trials in CNS, infectious diseases, and gastroenterology. It also supports BIOTECH research and medical devices with a patient-centric approach.

Maya and David discuss the following topics:

(2:30) Immigrant story from a clinical trial in Turkey

(7:12) What makes immigrants vulnerable patients

(9:50) The situation with immigrants and trials in the Balkans

(12:48) Ways to improve communication with authorities

(16:06) Tech portals vs direct communication with regulatory bodies

(19:40) What can ethics committees improve further

(23:02) The #1 thing to make trial patient-friendly

Tune in today for a thrilling journey into clinical trials – expand your knowledge! 

Maya Zlatanova, CEO of Trialhub

David Rosenbaum, Clinical Trial Manager @ Rosenbaum Group Ltd. 

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Rosenbaum Group Ltd. 

In this episode, Maya meets Dr. Leeza Osipenko. She is the founder and the CEO of a non-profit organization Consilium Scientific. It is dedicated to improving the integrity of clinical research.

Maya and Leeza discuss the following topics:

(2:18) The role of NICE in developing clinical standards

(6:23) Why did Leeza start Consilium Scientific

(9:35) How to avoid suboptimal clinical trials

(19:02) What are the mechanisms that improve clinical research integrity

(25:30) The ultimate goal of Consilium Scientific

(32:47) What is the biggest challenge in clinical trials at the moment

Tune in today for a thrilling journey into the world of clinical research – expand your knowledge! 

Maya Zlatanova, CEO of Trialhub

Leeza Osipenko, CEO of Consilium Scientific 

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Consilium Scientific

In this episode, Maya meets Andreas, who is a part of the new generation of CRO leaders. He has new ideas and concepts of how to bring better clinical research services to the market and make trials more accessible.

Maya and Andreas discuss the following topics:

(2:55) Why aren’t more students pursuing careers in clinical trials?

(6:35) What does the Association of International CROs do?

(10:49) How to balance global trial coverage with local support?

(8:32) Should big companies manage local teams as mini-companies?

(18:38) How to face clinical trial challenges as an international company?

(24:43) What’s the future of clinical research organizations?

Tune in today to catch the latest insights and emerging trends in the world of clinical trials. 

Maya Zlatanova, CEO of TrialHub

Andreas Beust, CEO of GCP-Service International and

President of AICROS

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GCP-Service International 

AICROS

In this episode, Maya meets Till, the founder of TranspariMED. Till is a political scientist by background, now focused on raising awareness about clinical trial transparency. 

Maya and Till discuss the following topics:

(1:19) How to achieve transparency in clinical trials

(3:37) Should all trials be fully transparent

(5:26) The current state of clinical trial transparency

(8:32) Who should enforce reporting clinical trial results

(14:58) Who benefits from opacity in clinical trial results

(20:35) How to foster better transparency in trials

(29:54) What makes or breaks clinical trials

Tune in today for a thrilling journey into the world of clinical trials – expand your knowledge! 

Maya Zlatanova, CEO of Trialhub

Till Bruckner, Founder of TranspariMED

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TranspariMED

In this episode, Maya meets Steve. Steve is the VP of partnerships for 1nHealth. He brings a wide-ranging scope of experience to his role, having worked previously in digital marketing, e-commerce, and education. He is primarily responsible for assessing digital recruitment feasibility and developing external partnerships.

Maya and Steve discuss the following topics:

(2:00) The common things between patient recruitment and e-commerce

(4:48) The 3 e-commerce tactics that can be applied to patient recruitment

(11:57) Are iterations of patient recruitment ads expensive

(13:53) The #1 platform for patient recruitment 

(19:59) Real-life stories from patient recruitment campaigns

(27:48) What makes or breaks clinical trials

Tune in today and start expanding your knowledge!

Maya Zlatanova, CEO of Trialhub

Steve Wimmer, VP of Partnerships for 1nHealth

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1nHealth

In this episode, Maya and Raymond discuss the following topics:

(2:09) What’s happening right now with clinical sites

(5:23) Should sites choose their own tech stack

(8:24) How to build better ePRO workflows

(13:06) The 1 way to offer global solutions for sites

(16:09) What is the future of sites

(23:09) How can clinical trials get more collaborative 

Tune in today and start expanding your knowledge!

Maya Zlatanova, CEO of Trialhub

Raymond Nomizu, Co-Founder of CRIO

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CRIO

In this episode, Maya sits with Carole Scrafton, Director and Co-Founder of a Patient Advocacy Organisation. They deep dive into the following topics:

(4:00) How has access to clinical trials altered?

(8:36) Do companies approach patients for clinical trials?

(11:47) How to assess proposals from small companies?

(16:13) Who should be more proactive: doctors or patients?

(19:55) Carole’s first experience with a clinical trial

(24:35) How to accelerate change in clinical trials?

Tune in today and start expanding your knowledge!

Maya Zlatanova, CEO of Trialhub

Carole Scrafton, Director & Co-Founder of Flutters and Strutters

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Flutters and Strutters

 In this episode, Maya and Kimberly, Founder and CEO of ESPERO, discuss the following topics:

(2:20) What does a Head of Digital Clinical Trials do?

(4:36) How can we speed up clinical trials?

(7:54) Top inefficient trial processes requiring a shift

(12:00) The main challenge in clinical trials

(15:38) Bridging the gap between companies and patients

(20:00) How to improve protocol design

(23:51) Why the industry is still not ready for AI and ML

Tune in today and start expanding your knowledge!

Maya Zlatanova, CEO of Trialhub

Kimberly Tableman, CEO of ESPERO

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ESPERO

In this episode, Maya and Duncan, president of DTS Language Services, shed light on translations involved in clinical trials. They discuss the following topics:

(2:09) The mission and purpose behind informed consent

(4:35) How to apply D&I to the informed consent 

(6:45) What problems arise in translating consent forms

(10:37) AI and translations in clinical trials

(12:47) Best practices in clinical research and translations

(15:54) Duncan’s experience from working with sponsors

(21:21) What makes or breaks a clinical trial

Tune in today and start expanding your knowledge!

Maya Zlatanova, CEO of Trialhub

Duncan Shaw, President at DTS Language Services

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DTS Language Services

In this episode, Maya and Aaron Horowitz, CEO & Founder of Empath Labs, dive deeper into the role of empathy in clinical trials. They discuss the following topics:

(2:43) Why did Aaron create Emapth Labs?

(4:46) How does the teddy bear from Empath Labs work?

(8:21) How does Aaron get inspired to create these products?

(11:09) How can you engage pediatric patients and understand their experience?

(14:46) How do companies feel toward the product?

(16:43) At what stage do CROs need the Empath Labs products?

(20:11) What is coming up next at Empath Labs?

Tune in today and start expanding your knowledge!

Maya Zlatanova, CEO of Trialhub

Aaron Horowitz, Founder & CEO at Empath Labs 

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Empath Labs

In this episode, Maya and Jennifer discuss the benefits of AI in clinical research and how it can assist medical writers in their day-to-day tasks. They also dive deeper into the cons of AI and the importance of the human-in-the-loop approach.

They thoroughly discuss the following topics:

(4:01) What does Narrativa do?

(6:21) How do people feel about AI entering clinical research?

(9:23) Are people embracing the technology or is there technology fatigue?

(13:25) What are the main challenges for AI?

(19:32) Are people’s old habits a barrier to AI entering the life science industry?

(21:58) Are companies ready to start working with AI?

(25:56) Is AI affordable for small to medium-sized companies?

Tune in today and start expanding your knowledge!

Maya Zlatanova, CEO of Trialhub

Jennifer Bittinger, President at Narrativa

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Narrativa

NEJM AI

In this episode Maya and Michelle Shogren, CEO of Innovate in What You Do? LLC, are discussing the importance of innovation in clinical research. Michelle has been on both sides of clinical trials - as a patient and as part of the operations teams. She has almost 20 years of experience in different roles -  caregiver, research coordinator, site and marketing director, CRA, and multiple roles in Pharma. Michelle is now running her own company with the same goal of helping people navigate and improve clinical trials.

They dive deep into the following topics:

(2:51) Top 3 Difficulties in Clinical Trials

(5:23) How do you find innovative and sustainable solutions?

(7:11) How do you integrate new solutions?

(10:01) Incubation period when implementing a new change

(14:09) How do you innovate while running a trial?

(16:14) Common mistakes when integrating new solutions

(18:10) How do you approach innovation in a small company?

(22:19) How do you pitch your solutions in the best way?

Tune in today and start expanding your knowledge!

Maya Zlatanova, CEO of Trialhub

Michelle Shogren, CEO of Innovate in What You Do! LLC

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Innovate in What You Do? LLC

In this episode, Maya is discussing the pros and cons of the Clinical Trials Information System (CTIS) with the Managing Director of FGK Clinical Research GmbH, Martin Krauss. By background, he is a trained statistician with more than 25 years of experience in the clinical research industry. 

They dive deep into the following topics:

(1:01) Who is Martin Krauss?

(3:34) Has the CTIS improved transparency and centralization in clinical trials?

(5:40) What are the strengths of the CTIS?

(7:19) What are the weaknesses of the CTIS?

(11:12) How does the CTIS help you as a CRO?

(14:17) What is the impact of the CTIS on the sponsors?

(15:38) Do you receive technical support from the CTIS?

(19:19) The UK is outside the CTIS. Is that a plus or a minus for them?

(21:18) Development of clinical trials in Europe vs USA

(24:30) Martin’s recommendations for working with the CTIS

Tune in today and start expanding your knowledge!

Maya Zlatanova, CEO of Trialhub

Martin Krauss, Managing Director of FGK Clinical Research GmbH

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FGK Clinical Research GmbH

In episode 7 Maya is talking to the founder and CEO of Bezyl Inc, Esther Howard. She has more than 20 years of experience in the health economics of developing countries and oncology clinical research operations. Her personal and professional experience inspired her to create her own company where she can focus on the mental health journey of every clinical trial patient. 

Maya and Esther deep dive into the following topics:

(2:23) What is Bezyl Inc.?

(4:16) What is the story of Bezyl Inc.?

(10:36) Given your background, what would you change in clinical trials?

(13:21) What practical advice would you give to address the patient’s and the site’s needs?

(17:13) How can we make sure we consider the patient’s input in the best way possible?

(19:46) What is the site’s role in patient engagement?

(22:00) What is Esther’s project related to diversity in clinical trials?

(27:48) The importance of focusing on the patient’s life and experience

Tune in today and start expanding your knowledge!

Maya Zlatanova, CEO of Trialhub

Esther Howard, SEO of Bezyl Inc.

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Bezyl Inc.

In this episode, Maya’s guest is Alexander O’Leary, Director of the PBC Group which hosts the Clinical Outsourcing Group (COG) event series with events in the UK, Europe, and the USA. He has close to 14 years of experience in organizing and running clinical research events. 

Maya and Alex discuss clinical research events both from the perspective of organizers and attendees. They deep dive into the biggest challenges and mistakes when planning and executing industry events 

Here are the key topics that they discuss:

(2:17) How do you find out what the most important topics for events are?

(3:57) Do events only cover topics on a superficial level?

(5:51) What makes or breaks a clinical trial (event)?

(8:54) Is it possible to create a synergy among the three stakeholders at events?

(13:09) How do you bridge the communication gap between patients and the industry?

(14:15) Why do people choose the attend a certain clinical research event?

(17:27) How do I select the right clinical trial event for my needs?

(19:34) Can events accelerate change in the clinical research industry?

Tune in today and start expanding your knowledge!

Maya Zlatanova, CEO of Trialhub

Alexander O’Leary, Director of PBC Group

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PBC Group

In this episode, Maya and Toni Perez discuss the challenges that small biotech companies face on a daily basis. Toni Perez has more than 36 years of experience in the clinical research industry. He has worked with both big and small pharmaceutical companies. Since 2007 he has been working as a consultant to smaller biotech companies with a headcount of 2 to 10.

Maya and Toni dive deep into topics of leadership, trust, and teamwork when it comes to doing clinical research. Having the right expertise in your team is crucial for the successful completion of clinical trials.

Here are the key topics that they discuss:

(3:36) What are the top challenges that small biotech companies face?

(5:03) What resources do you need when planning clinical trials as a small biotech?

(7:49) How do you plan a clinical trial without much experience in the industry?

(10:28) What type of professionals do you need in your team?

(12:18) Pros and cons of hiring part-time vs full-time professionals

(15:24) When should you work with a big CRO vs a small CRO?

(20:40) What is Toni’s advice to CEOs without a clinical research background?

Tune in today and start expanding your knowledge!

Maya Zlatanova, CEO of Trialhub

Toni Perez, Founder of Toni Perez Pharma Consulting

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TrialHub

Looking to enhance your knowledge of planning clinical trials? Tune in to this insightful podcast episode with Maya and Dan as they discuss practical ways to plan better clinical trials.

Discover the crucial roles that feasibility teams and CRAs play in clinical trials and how their involvement can significantly improve the success of the study. Additionally, learn about the importance of diversity in clinical trials and how we can make trials more accessible for a variety of populations. This can lead to better participant engagement and ultimately result in more accurate and reliable data.

Don't miss out on this opportunity to learn practical ways to improve your clinical trial planning. 

Tune in now and take the first step toward planning more successful clinical trials!

Here are the key topics that they discuss:

(2:28) How are feasibility teams involved in the planning process

(6:26) Do we need to work more closely with the coordinators?

(8:03) Should sites turn to the CRAs to discuss any issues with the trial?

(11:25) Are any extra endpoints discussed in the preliminary questionnaires?

(13:38) Do these endpoints apply to diversity in clinical trials?

(17:53) How can we shorten the distance between the sites and the decision-makers?

(20:54) What would you change when planning clinical trials?

Tune in to learn more!

Maya Zlatanova, CEO of Trialhub

Dan Sfera, Co-Founder and Site Director at Yuma Clinical Trials

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Yuma Clinical Trials

In this episode, Maya and Jacqui provide invaluable insights into the unique considerations that go into designing and executing pediatric clinical trials. 

From navigating ethical concerns to ensuring that children are properly represented in study populations, they cover all the key factors that can make or break a trial. But it's not just about the technical details – Maya and Jacqui also bring a human touch to the conversation. They discuss the impact that clinical trials can have on children and their families and share personal anecdotes that highlight the importance of putting the needs of patients first. 

Tune in today and start expanding your knowledge!

Here are the key topics that they discuss:

(3:34) Challenges in planning pediatric clinical trials

(8:30) Are decentralized trials improving pediatric research?

(13:30) What should we change in pediatric trials to make them more successful?

(18:49) Lack of resources and awareness in planning pediatric clinical trials

(22:11) Differences between trials for adults, adolescents, and children

(28:11) Problems in communication in the healthcare industry

(29:06) Helping with anxiety and trauma in clinical trial patients

Tune in to learn more!

Maya Zlatanova, CEO of Trialhub

Jacqui Whiteway, Senior Director & Pediatric Strategy Liaison at ICON plc

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ICON plc

Maya Zlatanova speaks with the CEO of Pharmaxi LLC, Yuriy Lebed. Pharmaxi is a clinical research organization based in Ukraine and operating in the Eastern European market. It was one of the first clinical organizations to restore clinical trials after the war began. Maya and Yuriy examine the clinical trial process during the war in Ukraine and the challenges in patient recruitment. They dive deeper into success factors in clinical trials, patient and data safety, etc. 

Here are the key topics that they discussed:

(2:34) How were clinical trials run prior to the war in Ukraine

(4:09) Factors that make Ukraine an appealing clinical trial destination

(8:45) How the clinical trial landscape changed after the war

(11:16) What factors are relevant to Ukraine’s success today?

(14:45) What are Ukraine’s current challenges in running successful clinical trials?

(17:48) What extra measures are taken to ensure patient and data safety?

(19:34) What was the approval procedure for the first clinical trial after the war started?

Tune in to learn more!

Maya Zlatanova, CEO of Trialhub

Yuriy Lebed, CEO of Pharmaxi LLC

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Pharmaxi LLC