Medable

Discover why a digital clinical platform is the best path forward for patients, sites, and sponsors.

https://www.pharmtech.com/pt_w/patient-choice

It’s no secret that the COVID-19 pandemic drove a rapid increase in the adoption of decentralized clinical trials (DCTs), which delivered ample benefits for sponsors, study teams and most importantly, patients. These benefits included:

Simplifying the sponsor technology ecosystem with one enterprise solution.

Reducing patient site visits by up to 75%.

Accelerating enrollment timelines by 50%.

Now that many sponsors are embracing DCTs, these organizations must focus on scaling their approach to ensure long-term success and positive return on investment (ROI). To achieve scale, digital strategies must be embedded early into the pipeline of pharma and biotech companies, requiring the formation of standardized processes and partnerships that work together to achieve a common goal.
To find out more, watch this free webinar with experts from Medable, Gilead Sciences , Syneos Health, and Veeva. The panel discusses best practices and provides examples on how to implement and scale DCTs across large organizations while mitigating potential risks.

Best practices for using digital technologies (ie, eConsent, eCOA, CTMS, eTMF, HHN, etc) and creating operational efficiencies in conjunction with existing processes across the product portfolio.

Examples of how shifting from a study-by-study approach to an enterprise platform approach can maximize ROI from DCT technologies.

How to re-think the end-to-end process and create the right ecosystem of partners to successfully scale a DCT strategy across an organization.

Clinical operations/research/development professionals

Founder/ President/ CEO/ Executive Directors

Chief Medical Officers / Chief Scientific Officers/ Chief Innovation Officers

Clinical trial strategy team professionals


Senior Director, Strategy & Growth
Medable

 is the Senior Director of Strategy & Growth at Medable. In this role, Sam leads the effort to scale the use of digital capabilities with Medable’s customers and partners, focusing on standardization and automation to drive cycle time reduction and increase data quality. Prior to joining Medable in 2021, Sam spent over a decade at Accenture working in roles that span across the healthcare ecosystem—with a focus on developing solutions that bridge the gap between standard of care and clinical trials. Most recently, he led teams with multiple top 20 pharma companies in driving DCT strategies. Sam holds a Bachelor of Science degree in Computer Engineering from the University of Minnesota.




Senior Vice President, Global Client Solutions
Syneos Health

 is an industry veteran, with over 25 years’ experience in the clinical, pre/post approval, and commercial arena. Having worked in large pharma, biotech, and CRO settings, Claire currently oversees strategic partnerships at Syneos Health with focus on bringing innovation and value to her clients by leveraging the full enterprise offerings of Syneos Health and the wider industry, including strategic partners. Claire is passionate about optimizing patient experience, technology offerings, and ways of working to ensure clinical trial execution is optimized without sacrificing quality.




Executive Director, Global RN Strategy and Patient Advocacy
Illingworth Research Group, a Syneos Health Company

 is the Executive Director of Global RN Strategy and Patient Advocacy at Illingworth Research Group, a Syneos Health company. She joined the company in 2011. Juliet has over 20 years’ experience within clinical research, commencing her career in cardiology research covering multiple Phase I-IV trials. More recently, she has specialized in neurology research, in particular, the field of multiple sclerosis. Juliet has wide experience in the management of trial projects, from initiation to close out, as well as experience working with site investigators to improve patient recruitment and patient retention to study protocols. She believes developing a strategy that places the patient in the center of the trial is vital for a successful study.




Vice President, Strategy Vault CDMS
Veeva, 

 is responsible for establishing Vault CDMS as the best-in-class solution for all data acquisition, management, and reporting purposes. This requires the considered provision of thought leadership, developing product and market strategy, and coordinating resources across the customer life cycle. With 25 years’ experience in Life Sciences, Richard is known for his keen executive vision and proven operational experience in data management, eClinical Solutions, and advanced clinical strategies.

Webcasts

Webinar Date/Time: Thursday, May 11th, 2023 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

The Digital Future is Now: Making Patient Choice a Reality

Many industries are adopting enterprise platform technology to reduce costs, streamline processes, and improve overall experiences. So, what is stopping life sciences? Discover why a digital clinical platform is the best path forward for patients, sites, and sponsors.


Research shows that the global decentralized clinical trial (DCT) market will reach $14B by 2026, but studies also suggest that up to 90% of clinical trials are at risk of failure. Faulty trial designs, patient retention, hidden costs, and flawed data collection determine the failure rate in clinical trials. However, the risks of study failure are reduced by taking a patient-first enterprise platform approach. By putting patients at the center of clinical trial design, they remain more engaged, becoming less likely to drop out whilst providing higher quality data.


Additionally, the financial returns of a platform approach are most evident across a portfolio of studies. Returns 5x greater than the initial investment for phase II trials and 13x greater than the initial investment for phase III trials were witnessed in the first financial model on DCTs from Tufts.
A study-by-study methodology presents many challenges, including soiled systems, inconsistent deployment processes, and disparate data sources. Solving these problems using platform technology is not a new concept, but it's only just gaining momentum in life sciences. Join this webinar to hear how top pharma teams have adopted digital platforms to reduce costs, improve patient experiences, and accelerate time to market.



The foundations of a platform technology approach and how to apply them to clinical research

How a tech model will help you generate greater ROI for clinical studies

The benefits of a clinical platform approach over siloed solutions

Real-world examples of top 10 pharma adoptions of a decentralized platform


General Manager, Decentralized Clinical Care
Medable

 is focused on the creation and execution of strategic programs which aim to serve the needs of patients, sites, and sponsors. Mo has over 21 years of industry experience across multiple pharma organizations and key stakeholders. He has led major technological transformations across the industry, aiding and leading to the adoption of several e-Initiatives to help facilitate the scalability of DCTs and digital applications. He has a background in pharmacology and is currently serving as a board of trustee member for the ACRP and the GM for Decentralized Clinical Care at Medable.




VP of Product Management
PlatformMedable



is Senior Vice President of Product at Medable. Before joining Medable, Shubha was Sr. Director of Product Management at Twilio and led the growth of Flex, a customer service engagement platform product by building a strong product practice and team of product leaders. Prior to joining Twilio, she was at AWS in core compute EC2 and storage S3 teams leading product areas to empower cloud-native builders and to drive on-premises cloud migration. In her product career, she spent over 11 years at Cisco leading several product lines as Director of Product Management, including @CiscoDevNet, Cisco WebEx, and Telepresence. Outside of work, Shubha is passionate about mentoring and runs and participates in several formal/informal programs to help people reach their goals.

The Platform Shift is Here How Pharma Sponsors Can Realize ROI Across Their Portfolio of Studies

The paper-based informed consent process is one of the most common causes of clinical trial failure. Find out how Medable’s Total Consent solution keeps patients engaged and reduces drop-out, whilst achieving compliance with global regulations.

For decades, issues with paper-based consent have been the source of the most common and most significant violations raised by Global Health Authority inspectors. In 2019 alone, more than 1/3 of all issued US Food and Drug Administration (FDA) Form 483s were related to informed consent findings. Additionally, the European Medicines Agency (EMA) reported that consent issues represented the 4th highest cause of critical inspection findings and the 5th highest cause of all site inspection findings.

These errors are costly, time-consuming and can jeopardize the completion of a trial. And these issues cannot be remediated with the continued use of paper-based consent, as they stem from the physical properties of paper itself.

That is why more and more sponsors have switched from paper consent to eConsent. But making this change must be more than just digitizing paper consent forms, the need for a complete informed consent process that better educates and retains patients while minimizing errors is key.

Join this webinar as industry experts identify the most common issues with the paper-based consent process and highlight what to look for in a complete consent management solution that reduces quality issues while improving oversight.



How a digitally enabled consenting process solves these issues

How to ensure quality by standardizing processes and deploying effective good clinical practice (GCP) training

How to deploy eConsent globally with regulatory compliant configurations and workflows

As General Manager for Consent Management, 

oversees the development of Medable’s Total Consent solution, as well as the implementation of eConsent in Medable studies, ensuring that Medable’s clients can run high quality, effective and efficient patient-first decentralized clinical trials. Andrew has 20 years of experience in managing clinical trials at large pharma, biotech and CRO companies, most recently as a Senior Director in one of Covance’s therapeutic area delivery groups and as Head of Business Performance. From his involvement in one of the earliest deployments of decentralized methodologies, he has been passionate about the benefits that this approach can bring in reducing the burden of clinical research on both sites and patients and looks to leverage his broad operational expertise to improve how this approach is utilized.




has over 20 years of pharmaceutical drug development experience in the areas of Global Clinical Operations, Global Clinical Development, and Quality Assurance. Over the course of her career, Shyanne has led Global R&D Quality organization at Boehringer Ingelheim, Intercept Pharma and tech start-up, TrialSpark. Prior to her leadership roles in Quality Assurance, she held leadership roles in global clinical operations functions at Abbott Laboratories, Novartis Oncology and Novartis Vaccines.


Webinar Date/Time: Tuesday, February 21st, 2023 at 11am EST | 8am PST | 4pm GMT | 5pm CET

The Importance of Quality in the Informed Consent Process for Pharma Sponsors

Articles

Traditionally, Oncology trials placed a heavy burden on patients due to travel burden, poor patient experience and multi-year clinical trial commitments. Sites also struggle with cancer trials due to enrollment delays, complex data workflows, and multiple amendments requiring re-consents. Today, we have a more effective, patient-first solution.

Optimize patient choice, improve retention and safety with Patient-
First Oncology solutions that meet patients where they are.

Optimizing Choice, Flexibility and Outcomes With Patient-First Data Collection for Oncology

With more than 50% of trials expected to be decentralized by 2024, many sponsors and CROs are learning that decentralizing clinical trials is not just for a pandemic. But despite adoption, there are still questions, myths, and rumors about what it means to “decentralize a trial”.
Listen in as experts from Medable and Incyte compare traditional trials (design first, patient second) with patient-centered trials (patient first, design second) and discuss how adopting a decentralized approach can help any organization, regardless of size or therapeutic areas focus, reimagine their existing approach to choreograph a masterfully designed patient-centered trial.




In this on-demand webinar, you will learn:


The fundamentals of decentralized clinical trials

Use cases for hybrid and fully decentralized approaches

Benefits of designing patient-centered clinical trials

Pharma Sponsors, Biotechs companies, CROs, University Research heads

Clinical operations / development professionals

Worked in the industry for over 25 years across all phases of clinical development in multiple sectors including Big Pharma (GSK, Pfizer, Novartis, Bayer), Biotech (Alnylam, Lexicon) and within the CRO space (Quintiles/IQVIA, Covance/LabCorp). Over the past 15 years have led Global teams in Project Management (Cardiovascular/Metabolic), Project Costing and Operational Strategy & Design and been instrumental in seeking, designing, and executing innovative solutions for client portfolios to meet the evolving and future needs of drug development. In her role within Medable, Claire will be collaborating with our clients and internal teams to shape DCT solutions that are designed around the patient to optimise inclusivity and operational efficiency to transform drug development and registration.




Senior Medical Director, US Medical Affairs
Incyte

Dr. John Galvin MD, MS, MPH is a hematologist in Chicago, IL and is Senior Medical Director, US Medical Affairs for Incyte Pharmaceuticals. Dr. Galvin is also affiliated with the University of Illinois Cancer Center. He has been in practice 11 years. He also has an affiliation with Northwestern University’s department of Immunology & Microbiology. He specializes in hematologic oncology with a focus on stem cell transplantation and graft versus host disease.

Thursday, October 20, 2022 at 11 AM EDT | 10 AM CDT | 8 AM PDT

It’s no secret that hybrid and decentralized trials (DCT) are here to stay. Make sure your organization is ready for the shift towards clinical trials that put patients first.