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From Spreadsheet Prison to Second Brain: The Upgrade That Pays for Itself
Read more »: From Spreadsheet Prison to Second Brain: The Upgrade That Pays for ItselfAdoption & Change in Clinical Operations: Why We Stay Stuck in Systems That Are Failing Us If you walk into almost any small or mid-sized biotech right now and ask, “Where does the real picture of our trial live?”, you’ll get the same answer in a hundred different flavours: “There’s a spreadsheet somewhere that has…
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The Quiet Exhaustion of Clinical Project Managers
Read more »: The Quiet Exhaustion of Clinical Project ManagersWhen enablement becomes the work, progress disappears. Clinical project management doesn’t stall because people stop caring.It stalls because caring alone can’t hold the weight of fragmented systems, conflicting priorities, and endless documentation. We know the story well.We’re living it. 1. The Heroism of Coping Every project manager in clinical development is a quiet hero of…
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Digital Oversight Is Here: Manual Systems Are the New Compliance Risk
Read more »: Digital Oversight Is Here: Manual Systems Are the New Compliance RiskSpreadsheet-based tracking can’t support RBQM or modern study accountability. Clinical project management isn’t failing because people don’t care, it’s failing because the systems we use were never designed for the weight we’ve put on them. 1. Life Inside the Project Delivery Machine Every morning starts the same way: Tabs, trackers, and tabs of trackers. One…
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Why Validation Documentation Alone Isn’t Enough (And What Actually Is)
Read more »: Why Validation Documentation Alone Isn’t Enough (And What Actually Is)You implement clinical trial software, you get validation documentation. Job done, right? Not even close. Here’s what actually happens: you’re mid-implementation and gaps appear in the validation package, your QA team asks questions you can’t answer, auditors want to understand methodology and testing details that aren’t documented, and you end up filling gaps yourself and…
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99 Problems in Vendor Management
Read more »: 99 Problems in Vendor ManagementLet’s be real – 99 problems is a lot. You don’t need to read them all (seriously, don’t feel obligated). Over hundreds of conversations, I’ve heard these same vendor management frustrations repeated again and again. These aren’t theoretical problems – they’re direct quotes from people dealing with this stuff daily. So here’s the deal: scan…
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Mayet Goes Modular!
Read more »: Mayet Goes Modular!In delivering software, we often face a choice: adopt an all-in-one solution with features we’ll never use, or cobble together multiple systems that don’t talk to each other properly. At Mayet, we decided it’s time for a different approach. We Asked, You Answered Since launching Mayet, we’ve had hundreds of conversations with clients and prospects…
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Integration Partnership with PHARMASEAL CTMS
Read more »: Integration Partnership with PHARMASEAL CTMSWe’re excited to announce our first integration partnership that connects our Vendor Management Software (VMS) with, PHARMASEAL, leading Clinical Trial Management System (CTMS). This powerful combination addresses key challenges faced by clinical research organisations today. See press release HERE: A Game-Changing Integration Our integration of Mayet and PHARMASEAL gives clinical trial teams complete visibility across…
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Mayet Strengthens Quality Leadership with Addition of New Strategic Advisor
Read more »: Mayet Strengthens Quality Leadership with Addition of New Strategic AdvisorWe are delighted to announce the appointment of Rosemarie Corrigan as Strategic Advisor to Mayet. With over three decades of experience in clinical research and medicines development, Rosemarie brings invaluable quality assurance and regulatory expertise to support Mayet’s growth trajectory. Rosemarie on joining Mayet: “Mayet’s platform transforms vendor oversight in life sciences, combining quality expertise…
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8 Transformative ICH E6(R3) Service Provider Management Requirements
Read more »: 8 Transformative ICH E6(R3) Service Provider Management RequirementsThe updates to ICH E6(R3) reflect the increasing complexity of clinical trials by establishing more explicit requirements for service provider management. While sponsors and investigators have always been accountable for trial activities, the new guidelines provide clearer expectations for vendor oversight in an ecosystem increasingly dependent on specialised service providers. Understanding these requirements is essential…
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The Human Side of Clinical Trial Quality
Read more »: The Human Side of Clinical Trial QualityWhy People Matter More Than Ever In the rush to adopt new technologies and adapt to regulatory changes, it’s easy to lose sight of what truly drives clinical trial quality: people. At RQA 2024, the most impactful moment wasn’t a technical presentation or regulatory update – it was a patient advocate sharing their journey, reminding…