Medable

Phase 4 trials have proven to be notoriously difficult for large pharma sponsors and CROs, who often struggle to recruit and retain the necessary patient population. Learn how digital trial solutions that leverage RWD can improve the quality of outcomes and patient experiences during these studies.

http://www.appliedclinicaltrialsonline.com/act_w/supercharge

It’s no secret that Phase 4 trials are incredibly time consuming, costly, and pose major challenges for sponsors and CROs alike. Whether it’s Long Term Follow Up (LTFU), Rollover, and Observational studies, or Registry and Consumer Health studies, sponsors often struggle to recruit and retain large numbers of participants. They also have difficulties addressing post-marketing commitments to assess long term drug safety and efficacy.

For a fraction of the cost, digital trial solutions (e.g., eConsent, eCOA, TeleVisit, Connected Sensors) combined with Real World Data (RWD) can solve traditional Phase 4 trial challenges while capturing the critical endpoint data needed for LTFU studies and informing future protocol designs and trial efficiencies.
In this webcast, Leader of TA Solutions at Medable, Musaddiq Khan, is joined by the Head of Real World Evidence Solutions at Syneos Health, Mike D'Ambrosio, and VP of Growth at Medable, Sam Bavery, to discuss how they have partnered to deploy patient-first digital trial solutions that leverage RWD, transforming it into actionable RWE insights for a sponsor client.

Through this webcast, you will learn how to optimize digital trial solutions in Phase 4 and LTFU studies by:

Transforming RWD into actionable RWE insights that inform future trials

Improving patient safety with remote monitoring and real-time data access

Boosting patient engagement and retention to drive higher quality data capture

Leveraging similar study characteristics to standardize study build and accelerate deployment

VP, Therapeutic Area Solutions
Leader
Medable

Musaddiq (“Muz”) has been involved in clinical research for over 17 years. Most recently, he was Director of Clinical Program Operations in the Exploratory Medicine & Pharmacology group at Eli Lilly, where he led the operational delivery of the First-in-Human study on Lilly’s COVID-19 Antibody programme. Throughout his career, Muz has held various clinical operations roles in pharma, including PAREXEL, Roche, and AstraZeneca.
Muz completed his Executive MBA from the University of Cambridge with a dissertation on “Developing a Digital Health Strategy for Early Clinical Development.”

Sam Bavery 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 standards 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.

Webcasts

Webinar Date/Time: Thu, Mar 16, 2023 11:00 AM EDT


How to Supercharge Real World Evidence Generation in Phase IV Trials

http://www.appliedclinicaltrialsonline.com/act_w/hybrid_decentralized

It’s no secret that hybrid and decentralized trials (DCT) are here to stay.

With EY-Parthenon reporting that more than 50% of trials will be decentralized by 2024, many sponsors and CROs are looking to gain the benefits of increased access to traditionally hard-to-reach patients, improved data, higher patient satisfaction, and more

Yet despite adoption, questions, myths, and rumors about what it means to “decentralize a trial,” persist.

Join us on July 13th at 11 AM EDT, as Andrew Mackinnon, VP & General Manager at Medable identify:

The fact and fiction around decentralized trials,

Why it’s not an “all or nothing approach” and;

The value of decentralization for patients, sites, and sponsors.

An understanding of hybrid and decentralized clinical trials (DCT)

Learn the facts and fiction around decentralized trials

Understand why decentralized trials is not an all or nothing approach

Pharma Sponsors, Biotechs companies, CROs, University Research heads

Clinical operations / development professionals

Founder/ President/ CEO/ Executive Directors

Chief Medical Officers / Chief Scientific Officers/ Chief Innovation Officers

Clinical trial strategy team professionals


Vice President & General Manager, eConsent
Medable


As General Manager for eConsent, Andrew Mackinnon oversees the development of the eConsent product, as well as the implementation of eConsent in Medable studies, ensuring that Medable’s clients can run high quality, effective and efficient 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.


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.

Wednesday, July, 13th, 2022 at 11am EDT | 10am CDT | 8am PDT
It’s no secret that hybrid and decentralized trials (DCT) are here to stay.

Yet despite adoption, questions, myths, & rumors about what it means to “decentralize a trial,” persist. Find out the truth from Medable.

Everything You Need to Know About Hybrid/Decentralized Trials

Articles

Browse your email, attend a conference or read a journal
and you are bound to see terms like ‘digital health’, ‘virtual’,
and ‘decentralized clinical trials’.
What is all the buzz?
Recruitment, retention, diversity,
efficiency, safety and accuracy are all
factors driving the need for radical
innovation. This need is painfully apparent
during the current COVID-19 pandemic.
We can no longer ‘do the same thing
and expect a different result’; it is time
to take some giant steps forward.

Breaking down the basics of decentralized clinical trials

How to create a seamless experience 
across eConsent, eCOA and more. Read our whitepaper to learn more!

The Building Blocks of DCT

Informed consent used to take place on lengthy, hard to comprehend paper consent forms, during inperson
for patients who were within travel distance to a physical site. Today, we have an easier, more
accessible solution called eConsent.
Optimize patient access to clinical research with a modern eConsent
platform that delivers an engaging, flexible and scalable user experience.

Tips for tailoring eConsent for Optimal Patient Centricity

http://www.appliedclinicaltrialsonline.com/act/RWD

The fragmentation of health data is one of the greatest challenges facing healthcare today. Patients have dozens of interactions with healthcare systems throughout their lives, and that information is retained in siloed databases across disparate institutions. With clinical trials being one of the most critical sources of evidence on drug effectiveness and safety, especially in oncology trials, it is imperative that we bridge the gap between clinical trial data and real-world data (RWD) to expand and extend trial value.

In this webinar, experts from Medable, Datavant and Parexel discuss how enriching oncology clinical trials with RWD generates deeper insights and improves operational efficiency to achieve better patient outcomes. By combining the power of a SaaS DCT platform with real-world data connectivity, therapies and new interventions can be approved faster and brought to market with higher fidelity evidence of their effectiveness and safety in a well-defined group of patients. This unlocks better outcomes, faster research, and healthcare at a lower cost.

By linking RWD with clinical trial data, sponsors can:

Optimize protocol and study design by adding richer clinical details about the patient's health

Ensure appropriate trial continuation by explaining and understanding patient response

Differentiate with a safe and effective intervention by observing long-term effectiveness

Simplify research by combining a decentralized clinical trial platform with the linkage of real-world data

Make the research experience frictionless for patients and sites by relieving them of the burden of clinic visits and manual data collection

Improve the quality and duration of evidence at a fraction of traditional trial costs

Clinical Operations/Development, Oncology Leads, R&D, Study Management, Chief Medical Officers, Chief Scientific Officers, Medical Affairs at Large Pharma and Mid-Market Biotech

Archana Sah is a clinical development thought leader with 26 years’ of experience and a passion for developing lifesaving medicines and products for patients. Having led and contributed to 15 FDA/EMEA drug approvals (12 in Oncology and Immuno-Oncology), Archana is widely recognized as a strategic expert on emerging topics ranging from therapeutic landscape and treatment trends expertise to innovation in clinical excellence. Archana has held leadership roles at Genentech/Roche, Bayer Oncology, Johnson & Johnson, ICON, and two oncology startups, CTI Biopharma and Tizona Therapeutics.

A leader in driving industry-wide strategic collaborations, Archana is passionate about bringing innovation and efficiencies across the entire clinical trials ecosystem with a patient-centric approach.

● Founding Chair, Oncology Board, Society for Clinical Research Sites

● Founding Chair, 2019, 2020, 2021 Annual Global Oncology Site Solutions Summit focused on delivering oncology clinical research best practices and solutions for operational excellence between Sites, Sponsors/CROs, Patients and Oncology Vendors

● Advisor, American Cancer Society Cancer Action Network focused on multiple topics including: Barriers to Clinical Trial Enrollment-policy implementation, Integrated Trial Matching for cancer patients and providers, Clinicaltrial.gov Modernization, COVID-19 Adaptation and Cancer Treatment Act

● Past Advisor, Forum on Drug Discovery & Development, National Academy of Sciences: Clinical Trial Site Standards and Harmonization

Vera Macoj is the Chief Scientific Officer at Datavant. Datavant is the leader in healthcare data connectivity, with the mission of "Connecting the World's Health Data to Improve Patient Outcomes". She leads a team focused on developing and defining key use cases for connected health data in research, including driving the connection between clinical trial data and real-world data. Vera is a scientist by training, and holds a BA in Biochemistry from Harvard College, and a PhD in Cell and Molecular Biology from the University of Pennsylvania Perelman School of Medicine. She has authored multiple peer-reviewed scientific papers in cancer research. Prior to joining Datavant, Vera worked at McKinsey & Company, where she supported pharmaceutical clients on growth strategy, business development, and M&A.

Michelle Hoiseth has been working in the drug and device development industry for 30 years. She has enjoyed a variety of positions that allowed her to create product development plans, run study operations, and support product commercialization objectives. Ms Hoiseth presently leads PAREXEL’s Scientific Data Organization and Real World Data Services team, working closely with her colleagues to solve the challenges to the use of real world data in clinical research.

Rizk joined Medable as the Chief Strategy Officer after leading the digital R&D cloud strategy at IQVIA for two years. Prior to that, Rizk was global vice president of CRO partnerships for Oracle for five years and previously was a director at Medidata Solutions and a project manager at Merck. In August, Rizk was named a PharmaVoice 100 leader. She is also a member of the Healthcare Businesswomen’s Association, Prix Galien Foundation Digital Advisory Board and Society for Clinical Research Sites (SCRS) Innovation Council.

Thursday, March 17, 2022 at 2pm EDT | 11am PT | 6pm GMT | 7pm CET

Oncology trials of the future are enriched with real-world data. Learn how to unlock better patient outcomes, faster research, and lower healthcare costs by combining a SaaS DCT platform with real-world data connectivity.