🚨📩 In the July edition of Trial Talks, we’re breaking down the latest news for diagnostics manufacturers on Laboratory Developed Tests (LDTs): ➡️ In May, the #FDA released its Final Rule, subjecting LDTs to the same enforcement approach as other IVDs. ➡️ Shortly after, the American Clinical Laboratory Association (ACLA) sued the FDA in an effort to stop the new LDT rule. ➡️ In July, the House Appropriations Committee expressed concern about implementing the final rule, stating that it has "the risk of greatly altering the United States' laboratory testing infrastructure." ➡️ Presently, The final rule's implementation has been halted until the FDA partners with Congress to revise it. Find out everything you need to know about the new FDA regulation, why many industry leaders are opposed to the ruling, and how you can start preparing here: https://bit.ly/3YlY3mu
Medrio
Software Development
San Francisco, CA 9,676 followers
Powering your research potential.
About us
At Medrio, we're fueled by an ambitious vision: to improve 100 million lives by enabling secure, reliable, and efficient clinical trials. Since 2005, we have cultivated a thriving network of individuals who share a common goal of making a positive impact - including our dedicated team of Medrians, valued customers, and trusted partners. Our eClinical solutions are flexible and configurable to meet the needs of any clinical trial - from traditional to fully decentralized. Our solutions are easy to learn, easy to use, scalable and connected through one unified platform, providing unmatched efficiency, reliability, clarity and sophistication. As an employer, our core values are rooted in a customer-first approach, an A-player mindset, and a sprinkle of quirkiness to keep things fun and interesting. We are dedicated to powering the potential of clinical research - and we invite you to be a part of our mission. Visit our website to learn more, request a demo, or apply to join our team.
- Website
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http://www.medrio.com
External link for Medrio
- Industry
- Software Development
- Company size
- 51-200 employees
- Headquarters
- San Francisco, CA
- Type
- Privately Held
- Founded
- 2005
- Specialties
- Electronic Data Capture (EDC), eClinical, Electronic Case Report Forms (eCRF), Electronic Patient-Reported Outcomes (ePRO), Data Management, Clinical Research Organization (CRO), Phase 1-4, patient centricity, eCOA, eSource, Clinical Trials , Easy-to-use, RTSM, Randomization and Trial Supply Management, Electronic Consent (eConsent), Electronic Data Capture (EDC), and Clinical Data Management
Locations
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Primary
345 California Street
Suite 600
San Francisco, CA 94104, US
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1 St Katharine's Way
London, England E1W 1, GB
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2nd floor
Sai Apex 201, Viman Nagar,
Datta Mandir Chowk, Pune 411014, IN
Employees at Medrio
Updates
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📆 Day in and day out, every Medrio employee makes a unique contribution towards better experiences for clinical trial researchers and participants. This week at #MedrioRetreat, we're celebrating the hard-working Medrians who've been making those contributions for years. Medrio has grown significantly in recent years, and this committed group has been there there every step of the way, helping the team leap into the future with confidence. Join us in recognizing the outstanding winners of our 2024 service awards who have hit the milestone of either 3 years or 5 years with Team Medrio! ⭐ 3 Years of Service at Medrio: Amanda Bise, Andrea Mills Andrew Ferrin, Rebecca Jones, Bhavani Jaikaria, Cody Pearce, Danielle Plucinski, Dawn Al-Ardhromli, Ed Gould, Hamsa Kumar, Jessica Guardado, Juhi Shah, Ileana Acebo Ellis, Kate Peterson, Kathy Cole, Lindsay Washick, Matt Cockayne, Prachi Patel, Rebecca Conover, Rod McGlashing, Nicola Alexander, Simone Anell, Ian Davison, Graeme Ferguson, Brent Harlow, Stuart Henderson, Marcin Jerwan, Christopher Johnstone, Cameron Kinnear, Vaidehi Patel, Megan Ruiter, Shyamala Veerasamy, Laurence Woodward, Jason Hill, Tyler Ellis, Roshni Lauber Seth Kohlbrand, Sunil S. ⭐ 5 Years of Service at Medrio: Alanna Rhine, Anita Wong, Muhammad Bilal Martin Hochberg, Mike Lewis
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🔵 #MedrioRetreat 2024 is officially underway! 🔵 The biggest takeaway from our first day in Park City? Team Medrio is one resilient and inspired group. Due to global tech outages, many had to journey longer and farther than expected, and some had to cancel their travel plans altogether. But when things don’t go as planned here at Medrio, our agile instincts kick into action. We adjusted agendas, shifted content planning, and set up virtual meeting options on-the-fly so everyone could participate together. Whether you were attending virtually or in-person, you could feel the positive energy at Nicole Latimer's opening address and the excitement for what’s to come this week. Here’s to you, Team Medrio 👏 Check out some pictures from Day 1 below, courtesy of remote and in-person attendees, and stay tuned for more Retreat updates!
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🌱⭐ Did you know that using ePRO in your clinical trials can help protect the environment? By digitally collecting patient-reported outcomes, sponsors can reduce or even eliminate their paper waste and the environmental impact associated with traditional paper PRO methods. Discover how to make your trials more sustainable and other ePRO advantages in our paper vs. ePRO guide: https://bit.ly/3xNUVoy #ClinicalTrials #ePRO #EarlyPhaseTrials #DataQuality
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📢 Put an end to costly delays caused by mid-study updates! Join our product demo tomorrow for an exclusive look inside Medrio CDMS/EDC. You’ll see how Medrio puts you in control of the implementation, validation and deployment of protocol changes after your study is live. The result? Minimal downtime and a faster return to collecting vital study data. Register now: https://bit.ly/4d0pje4 #EDC #CDMS #ProductDemo #ClinicalDataManagement #ClinicalTrials
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👉 Why are industry leaders wary of the FDA’s final rule on Laboratory Developed Tests (LDTs)? According to the #FDA, the new policy will help ensure LDTs are safe, effective, and accessible to patients. But until recently, this category of in vitro diagnostics was exempt from FDA oversight. Industry leaders argue stricter standards could create barriers for patients who need access to LDTs. Get all you need to know about the FDA's ruling on LDTs and how the House Appropriations Committee has responded in the latest edition of Trial Talks.
The Future of Laboratory Developed Tests Under FDA Scrutiny
Medrio on LinkedIn
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👋 Small research team with big ambitions? Simply put, you need to build a database that can keep up with the growing demands of your research. Working with hundreds of emerging research teams has taught us a valuable lesson: it’s never too soon to start planning for scalability. Before you know it, your research will involve more participants and larger volumes of data. Making intentional database decisions now ensures you get the most out of your data and stay compliant in the future. ➡️ Read the full eBook with expert guidance from Rochelle Shearlds, MBA, Charles G., and Tony Brown to see what’s important to consider when designing your database: https://bit.ly/3W8dlbI
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Don’t want the pressure of committing to a one-on-one product demo? Get an inside look at Medrio’s EDC/CDMS with our virtual product walkthrough! Take a tour inside our EDC/CDMS software with Tony Brown and more Medrio experts to see how you can: 🔵 Stay in control, on time, and on budget 🔵 Mitigate the impact of mid-study changes on existing workflows 🔵 Safeguard your live study environment 🔵 Test new Medrio features Join us for the webinar on July 23rd to get all the value of a demo without the commitment: https://bit.ly/4d0pje4 #EDC #CDMS #DataQuality #ClinicalDataManagement #ClinicalTrials
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📣 Our partners at Swing Therapeutics, Inc. just made a huge leap forward for managing chronic pain caused by fibromyalgia! Last week, they announced the publication of data in The Lancet from their Phase 3 trial of Stanza, a new behavioral therapy for fibromyalgia treatment. Stanza is truly groundbreaking. It delivers acceptance and commitment therapy (ACT), a type of cognitive behavioral therapy that’s been validated as an effective treatment for fibromyalgia, but that’s largely inaccessible to patients. Now via Stanza, patients can access ACT directly from their smartphone, and the results are overwhelmingly positive. A multi-center, randomized controlled trial clinically validated Stanza’s benefits, including improvements in well-being, severity, and major symptoms. It’s also the largest study on an FDA-cleared medical device for fibromyalgia that has ever been undertaken. ⭐ We’re proud to partner with Swing on this journey to create more accessible treatment options and healthier lives for people living with chronic pain! Dive into findings from the pivotal Phase 3 study on Stanza here: https://bit.ly/4bKo2H6
Swing Therapeutics Announces The Lancet Publication of Data from Phase 3 Trial of Stanza™ - a Digital Behavioral Therapy for Fibromyalgia Symptoms
https://swingtherapeutics.com
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Why choose a CDMS/EDC partner that prioritizes data accessibility? Whether you’re working alone or with a small team, oversight can help you monitor progress and identify actions to stay on track as your research operations grow. 🔻 See at-a-glance below what features and functionalities you should look for in a CDMS/EDC to support real-time, data-driven decisions. Read the full eBook on strategic scaling for emerging companies here: https://bit.ly/3XjTrN5 #EDC #CDMS #ClinicalTrials #ClinicalDataManagement #DataQuality