Medable

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.

Webcasts

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.

Enriching Oncology Studies with RWD Before, During and After the Trial

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

Within our industry, expertise has consistently proven itself a key driver of innovation. Together we can help guide and share our scientific development model, furthering our vision of opening scientific research to the entire world. Today, organizations worldwide are revamping their research and development engines, adding decentralized capabilities to their traditional suite of services. As a pioneer in this space, Medable is best positioned to help empower this radical transformation to future-proof and enable next-generation clinical research at scale.

In this webcast, here how the Medable Academy:

Provides life sciences companies with specialized tools, knowledge sharing and skills development to rapidly scale decentralized and hybrid trial strategies

Offers education and foundational knowledge of decentralized trials

Certifies roles that an organization needs to design, build, and launch their own studies

Understand how your organization can quickly and easily learn about decentralized fit-for-purpose strategies

Utilize the Medable Academy to codify emerging skills and learning paths that empower individuals and teams to design, build, deploy and support decentralized and hybrid trials

Hear how you and Medable together empower radical transformation to future-proof and enable next-generation clinical research at scale

All LifeSciences: Sponsor, Sites, CRO’s from all market segments and personas

Jared Klingeisen is Senior Vice President at Medable, where he partners with industry leaders to innovate and adopt DCT in clinical trials. He’s served on the Medable team since the early days of the company in 2018 and founded the company’s operational delivery model that has been used to deliver innovative solutions to 150+ clinical trials. Jared has worked at hypergrowth health tech companies for the past decade, previously as Implementation Executive at Epic, the largest medical record provider in the US.

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

Wednesday, September 15, 2021 at 11am EDT | 10am CDT | 4pm BST | 5pm CEST
It’s with this in mind that we invite you to join us in an industry-first training and certification program  that provides the specialized tools, knowledge, and skills necessary to develop and scale decentralized trials. Together, we can help codify new roles and learning paths that empower the industry to design, build, deploy and support decentralized trials. We can scale best practices and shared expertise to help trial teams break down traditional barriers, reduce cycle times, enhance data quality, and improve patient access and experience. But most importantly, in doing this we help scale a more inclusive scientific future for all.

Medable

Articles

Everything You Need to Know About Hybrid/Decentralized Trials

Breaking down the basics of decentralized clinical trials

The Building Blocks of DCT

Tips for tailoring eConsent for Optimal Patient Centricity

Enriching Oncology Studies with RWD Before, During and After the Trial

A New Path Forward to Empower Your Team Utilizing Decentralized Clinical Trials