Is your organization ready for the changes that are going to impact your biospecimen management processes when the European Medicines Agency (EMA) officially adopts ICH E6(R3) on July 23, 2025? Failure to adapt could eventually result in: ➡️ Increased audit findings and regulatory scrutiny ➡️ Data integrity concerns that impact trial outcomes ➡️ Delays in study timelines due to noncompliant biospecimen ops ➡️ Financial and reputational consequences from failed inspections Read the blog below to stay ahead of the curve and ensure compliance.
Slope
Biotechnology Research
Richmond, Virginia 13,660 followers
A global provider of biospecimen lifecycle software, data, and services for complex clinical trials.
About us
Slope is a global provider of biospecimen lifecycle software, data, and services for clinical trials. With a focus on tech-enabling the full biospecimen lifecycle, Slope offers expertise that empowers sponsors to make informed decisions using high-quality, real-time sample data. Slope has supported thousands of the most complex, sample-intensive trials worldwide and has been adopted by nearly 80% of NCI-designated cancer centers. Biospecimen360™ is a biospecimen lifecycle software solution that provides sponsors with real-time, compliant, and traceable sample data to inform timely study decisions. The software controls sample metadata capture and orchestrates multi-stakeholder activities and data flow throughout the biospecimen lifecycle — from kit logistics and inventory control to sample collection, processing, storage, and shipping, to receipt at labs. The result is instant data availability across sites, labs, kitters, shippers, and other eClinical systems; this in turn enables faster reconciliation, less risk, and significantly improved study compliance, monitoring, and reporting. When sites support a trial that uses Biospecimen360™, they gain comprehensive access to advanced inventory and sample management tools that seamlessly guide them through every step of sample collection, processing, storage, and shipping. Additionally, we provide free inventory management software for sites to use across all of their trials, empowering them to streamline their operations with ease.
- Website
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https://www.slopeclinical.com/
External link for Slope
- Industry
- Biotechnology Research
- Company size
- 51-200 employees
- Headquarters
- Richmond, Virginia
- Type
- Privately Held
- Founded
- 2016
- Specialties
- B2B SaaS Software, clinical trial management, sample management, clinical inventory management, data-driven resupply, and clinical trial execution
Locations
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Primary
Richmond, Virginia 23294, US
Employees at Slope
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Michael Felix
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James Irvin
Senior Director of Quality at Slope
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Terry L. Edwards
Accomplished leader with a track record of success in scaling teams and organizations from startup to profitable exit.
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Amy Ripston
Vice President of Marketing for Slope | Founder and Executive Director for BMC | Brand Builder and Storyteller
Updates
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The transition from ICH E6(R2) to ICH E6(R3) marks a pivotal shift in regulatory expectations for biospecimen management in clinical research. With an expanded emphasis on risk-based quality management, enhanced data governance requirements, and increased sponsor oversight responsibilities, organizations must evolve their internal processes to maintain compliance. Join Slope CEO, Rust Felix, alongside industry experts Edye Edens and Aman Khera on April 15th as they delve into how ICH E6(R3) will impact biospecimen management practices. Register here: https://hubs.la/Q03d9PDD0
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Congratulations to Teal Health on unveiling landmark results from their SELF-CERV study! The data confirms that self-collected samples using the Teal Wand™ match clinician-collected samples — validating Teal's at-home cervical cancer screening as a preferred and viable alternative to in-person screening. At Slope, we’re proud to have supported Teal Health’s pivotal trial by providing our Biospecimen360™ software for biospecimen and inventory management — helping them hit their enrollment target 23% faster, giving them sample metadata access within 4.8 hours of sample collection on average, and eliminating inventory and sample-related deviations. This groundbreaking partnership helped Teal Health secure FDA Breakthrough Device Designation, paving the way for more accessible cervical cancer screening options. Click here to read Teal Health’s full press release: https://hubs.la/Q03cBSv00 Read our full case study to learn how Slope’s collaboration with Teal Health played a role in this achievement: https://hubs.la/Q03cBDjS0
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🚀 Meet Brian Smith, Slope’s New VP of Product! 🚀 With a career spanning clinical operations, product management, and data management across leading labs and technology vendors, Brian brings a unique perspective to biospecimen management. In this Q&A, Brian shares: • Key trends shaping biospecimen logistics in clinical trials • The role AI will play in streamlining sample management • How Slope is evolving to meet the ever-changing needs of sponsors and sites 📖 Read the full Q&A here: https://lnkd.in/eWb8w3ph
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Day 3 of #SCOPESummit got off to a strong start this morning as we presented on the power of agnostic data sharing with LabConnect and CellCarta. If you want to chat more about why a unified clinical ecosystem is the key to transforming #clinicalresearch, make sure you stop by this afternoon to see us on the show floor! You can find us at: • Booth #1216 – Slope • Booth #908 – LabConnect • Booth #1221 – CellCarta #SCOPE2025
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We're ready for another great day at #SCOPESummit! Don't forget to catch our panel this morning at 9:55am in Suwannee 15. We hope to see you there!
We're less than one week away from one of our favorite shows of the year: #SCOPESummit! With so many enlightening presentations ahead, we're excited to be a part of this year's jam-packed agenda. Join our very own Mark Melton, CellCarta's Anne MacNeil, and LabConnect's John Mapel for this joint presentation. You'll walk away with an understanding of the: ➡️ Challenges of a fragmented clinical ecosystem on data sharing and quality ➡️ Status quo and need for agnostic data sharing ➡️ Existing case studies on collaborations for inventory and sample metadata continuity ➡️ Key to transforming clinical research #SCOPE2025 #Biomarkers #PrecisionMedicine #Biospecimens
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We're feeling the excitement of #SCOPESummit this morning at Booth #1216! Stop by to learn more from our team about how we connect sponsors, sites, labs, and CROs with our vendor-agnostic biospecimen lifecycle software. #SCOPE2025
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We're less than one week away from one of our favorite shows of the year: #SCOPESummit! With so many enlightening presentations ahead, we're excited to be a part of this year's jam-packed agenda. Join our very own Mark Melton, CellCarta's Anne MacNeil, and LabConnect's John Mapel for this joint presentation. You'll walk away with an understanding of the: ➡️ Challenges of a fragmented clinical ecosystem on data sharing and quality ➡️ Status quo and need for agnostic data sharing ➡️ Existing case studies on collaborations for inventory and sample metadata continuity ➡️ Key to transforming clinical research #SCOPE2025 #Biomarkers #PrecisionMedicine #Biospecimens
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We’re thrilled to announce that CellCarta has launched their new Kit Inventory Portal, powered by Slope! This innovation significantly streamlines kit inventory management for sponsors and research sites who leverage CellCarta for kitting. Today, 83% of NCI-designated cancer centers already rely on Slope’s free inventory solution to maintain efficient study operations. We’re excited to continue expanding this solution to benefit even more research sites and sponsors, driving better clinical trials. Learn more: https://lnkd.in/eaKPKdYE
📣 We’re making it easier for clinical sites to maintain efficient, uninterrupted clinical operations! 📣 Our new Kit Inventory Portal powered by Slope streamlines the management of kit inventory for clinical sites. Research sites will be able to: ⭐ Order kits on the online portal ⭐ Access real-time inventory insights ⭐ Easily track expiration dates ⭐ Automate resupply Discover more about our new Kit Inventory Portal, and how it can drive your research forward: https://bit.ly/3E46Ktf #ClinicalTrials #PrecisionMedicine #SampleManagement #Digitalization 📣 We’ve made clinical inventory management smoother! 📣
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2024 flew by. From groundbreaking collaborations to exciting advancements in biospecimen management, this year has been a testament to the power of innovation in our industry. Together, we can continue building a future where patients are paramount in clinical research. From the Slope team to you, we wish you and yours a safe and happy holiday season!
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