David Starnes

There is a downturn in the IT job market. What should all IT professionals do during this time? As I discussed with a colleague today, it's critical to keep learning and developing yourself as a professional. This "never-stop-learning" attitude is key to standing out from the crowd. #neverstoplearning #lifelonglearner https://lnkd.in/eFx8bS75

46

6 Comments

𝗟𝗲𝘀𝘀𝗼𝗻𝘀 𝗳𝗿𝗼𝗺 𝗧𝗵𝗲 𝗣𝗵𝗼𝗲𝗻𝗶𝘅 𝗣𝗿𝗼𝗷𝗲𝗰𝘁: 𝗔 𝗠𝘂𝘀𝘁-𝗥𝗲𝗮𝗱 𝗳𝗼𝗿 𝗜𝗧 𝗮𝗻𝗱 𝗕𝘂𝘀𝗶𝗻𝗲𝘀𝘀 𝗟𝗲𝗮𝗱𝗲𝗿𝘀 The Phoenix Project by Gene Kim, Kevin Behr, and George Spafford tells the story of Parts Unlimited, a company on the brink of failure due to mismanaged IT projects and outdated operational practices. At the center is Bill Palmer, who unexpectedly becomes the VP of IT Operations and takes charge of rescuing the company’s most critical initiative: the “Phoenix Project.” With growing inefficiencies and rising costs, Bill turns to Erik, a mentor who introduces him to lean manufacturing principles and the Three Ways of DevOps: 𝗳𝗹𝗼𝘄, 𝗳𝗲𝗲𝗱𝗯𝗮𝗰𝗸, 𝗮𝗻𝗱 𝗰𝗼𝗻𝘁𝗶𝗻𝘂𝗼𝘂𝘀 𝗹𝗲𝗮𝗿𝗻𝗶𝗻𝗴. By applying these concepts, Bill: - Improves IT workflow, reduces work-in-progress (WIP), and fosters better communication across development, operations, and business teams. - Automates repetitive tasks to minimize errors and enhance productivity. - Focuses on streamlining value delivery across the organization. The book emphasizes valuable lessons, including: - IT as a driver of business growth through innovation. - The importance of breaking down silos with interdepartmental collaboration. - Leadership's role in empowering teams and fostering a culture of continuous improvement. The Phoenix Project serves as an essential guide for organizations seeking to embrace IT and DevOps practices to enhance performance, agility, and resilience. Have you read it? What lessons resonated with you? #ThePhoenixProject #DevOps #ITManagement #BusinessTransformation #LeanIT #DigitalTransformation #Leadership #Innovation #Collaboration

2

The FDA recently released guidance on the use of EHR and Claims based RWD to support regulatory decision-making. The guidance points out the weaknesses of using claims and EHR data alone to support RWE. I put together the following “thought exercise” to examine what data sources would be necessary to create a “complete” RWD asset. Overly simplistic? Useful Framework? Missing key data sources? I would welcome your opinions. https://lnkd.in/e-YAauhT #RWD #RWE #RegulatoryGradeData #FDA_guidelines 

31

4 Comments

If you're hungry for AI 🤖 , Gartner has an AI Technology Sandwich 🥪 to satisfy your cravings! Bottom line 💡 , balancing both centralised and decentralise AI is tricky but essential for pace, scale and adoption. Take on AI in bite-sized chunks 🍔 🍴

8

***Building a Foundation of Data Trust and Quality in AI**** In the intricate landscape of data management and AI development, the intertwined concepts of Data Trust and Data Quality emerge as foundational pillars. Data Quality: The ‘What’ The ‘what’ of data—its accuracy, completeness, and reliability—is meticulously managed through tools for defining, executing, and remediating quality rules. This is the data we have diligently stored in our systems, forming the backbone of our AI’s knowledge. Data Trust: The ‘Why, Who, When, How, and For Whom’ Beyond the ‘what’, it’s the trust that stakeholders place in data—encompassing the ‘why, who, when, how, and for whom’—that truly empowers AI. Data Trust is about more than just quality; it’s about the governance, ethical use, and transparency that surround data handling, solidifying the trust in the data we use. Without a foundation of trust and quality, data cannot be effectively leveraged, leaving even the most advanced AI tools short of their potential. For AI to reach its zenith, it must operate on data that is not only high-quality but also deeply trusted. This trust ensures that the insights and decisions AI offers are not only relevant but also respected and accepted. Context: The Narrative Often Left Untold Conversely, the context—the narrative often left untold—is critical for top-level decision-making. It’s the metadata that breathes life into raw numbers, transforming them into meaningful insights. Without context, the promise of AI falters, unable to unlock the full spectrum of its capabilities. In the quest for AI excellence, Data Trust and Data Quality are not just buzzwords; they are the bedrock of innovation. As we stand on the brink of AI’s potential, let’s not forget the importance of context—the untold narrative that turns data into wisdom. It’s this blend of quality, trust, and context that will propel AI from mere computation to a trusted advisor in our digital future. Let’s engage, innovate, and inspire a future where AI is synonymous with trust and quality. What are your thoughts on building this future together? #DataStrategy, #DataQuality, #AI

4

Linkage of RWE sources is becoming a key part of the narrative overall data collection strategies. The worlds of data generated from site-mediated, patient-mediated and real world data collection are colliding, but as many of us know, it’s far from straight forward as to specifics on when and where this can be applied. Precision in the evaluation of potential real world data sources, and true understanding of data linkage is vital in ensuring your data strategy and regulations are starting to catch up. Click here https://hubs.ly/Q02DTxHg0 to join my colleagues from Navidence as they discuss this topic with our friends at Castor.

15

1 Comment

There are so many “solution providers” in our field. There are dozens of solution providers for every area of research. Ecoa EDC Ehr Supply vendors Recruitment vendors (probably a million of these) Business Development vendors (15% of overall budget to get you a study sometimes, and really they are just using ChatGPT to talk to sponsors - just go to conferences and shake hands… sponsor reps are actually pleasant and very approachable) There are so many “solutions” that it’s almost impossible to feel like you’re choosing the right one. Time, money, emotional wearwithal to implement a new solution just to watch it not work for you. Then there are the solutions the sponsors provide. Albeit some are tried and true and work as consistently as the sun most days. But there are the others where it feels like I’m failing my employees or patients by making them use it. Everyone says their solution is “the best” “the fastest” or “better”. Where are the metrics? I sometimes think how fun it would be just to have a battle royal between the solution providers and see who comes out the victor. But it’s hard to measure. What’s the answer? I go to the conferences and sometimes the exhibition hall feels like the perfume department at Macy’s. It’s overwhelming to think there’s probably a solution out there that will revolutionize the industry that is stuck in pool of perfume sales representatives. My thoughts: Education: looking for onboarding staff who are ahead of the curve: Clinical Research Fastrack Looking to really push your staff to be the best they can be: Clinical Research Project Management Association (CRPM Association) Looking to have a tech solution as a sponsor or cro that will revolutionize the industry: Yonalink ECOA for sponsors: Medidata Solutions Site sided solutions: CRIO and Florence Healthcare Advertising: honestly good luck… idk maybe pray? I know I don’t have all the solutions and haven’t used all of the solutions. Subjectively these listed are the ones I have seen do quality work and genuinely care about the industry and their product within it. Would still be interested in a battle royal. Not like fighting but just a tech runway for sites where you as a solution provider come and pitch your products to sites and sponsors. Show it off. Show real time usage. Support it with metrics and data and case studies. Solutions you can tell me what the inundation to my site would be statistically and if you’re going to ask for 5 it’s because you know you’re going to make me 10. Also for sponsors, maybe let sites opt out of your assistance solutions but provide them the financial means that you would have paid your vendor for them to suggest their own. Just because you were sold doesn’t mean it adds value to sites. Sometimes a vendor can be more of a burden than the whole trial.

45

18 Comments

Take a look at this new video highlighting our Amplity Commercial Solutions capability! Let's discuss how Amplity Health can help optimize launch success with our contract sales teams. Enjoy!

2

𝗪𝗵𝗮𝘁 𝗮𝗿𝗲 𝘁𝗵𝗲 𝗸𝗲𝘆 𝗳𝗲𝗮𝘁𝘂𝗿𝗲𝘀 𝗼𝗳 𝗼𝘂𝗿 𝗰𝗗𝗜 𝗣𝗹𝗮𝘁𝗳𝗼𝗿𝗺? Our cDI Platform provides the core features for all the apps. This includes collaboration, connectivity, automation, analytics, administration, etc. 1. Scrum boards help agile teams break large, complex projects into manageable pieces of work so focused teams, working in sprints, ship projects faster. 2. You can keep your teams and organization in sync with roadmaps. 3. You can make data-driven decisions in record speed with Analytics. Use pre-built or customized dashboards to analyze your data across teams and projects. The Data Lake offers fully modeled data across apps for faster analysis, directly inside the Platform. 4. Execute electronic signatures on any issue. Each signature contains signee name, title, date/time, signature meaning and is locked cryptographically to the Issue. 5. Will capture a PDF point-in-time snapshot of the complete “Signed” issue. PDF includes standard fields, description, attachments, comments and all custom fields, plus eSign signatures , invites and verification. 6. Save time from manual exports and scripts with automated daily backups. Trigger on-demand backups for all or specific projects or objects including attachments. Monitor and report backup activity for compliance. 7. Instantly build reports with Power BI dashboard templates and pre-configured data sources. Just download one of the templates and get your report in Power BI without a hassle. Our platform is secure and compliant. Guaranteed 99.95% uptime SLA. Supports full Office 365 and Power BI Integration. 𝘊𝘰𝘯𝘵𝘢𝘤𝘵 𝘶𝘴 𝘢𝘵 𝘪𝘯𝘧𝘰 𝘢𝘵 𝘊𝘰𝘯𝘵𝘪𝘯𝘶𝘰𝘶𝘴𝘝𝘢𝘭𝘪𝘥𝘢𝘵𝘪𝘰𝘯.𝘤𝘰𝘮 𝘧𝘰𝘳 𝘮𝘰𝘳𝘦 𝘪𝘯𝘧𝘰𝘳𝘮𝘢𝘵𝘪𝘰𝘯. 𝘛𝘩𝘢𝘯𝘬 𝘺𝘰𝘶!

10

Thoughts on this? >> SmarterDx Launches AI-Powered Appeals Solution to Fight Payer Denials >> Comment below! >>> lqventures.com #mhealth #IoT #industry40 #healthtech #AI

1

Thoughtful planning in the establishment of a commercial data strategy prior to brand launch can help to frame the approach to patient-centricity. Data warehouses are a lot of work to rebuild, the tips in this Beghou Consulting article help to provide four keys to inform that planning so that patients stay at the center of focus. #data #pharma #biotech #patient-centered

15

The new Order Tracker Experience (OTE) gives providers real-time visibility of test order status. Whether you order through your EHR, Labcorp Link or manual requisition, OTE offers comprehensive tracking, enhancing your ability to manage patient care effectively with clear, up-to-date information on all your test orders. Learn how OTE can enhance your test ordering experience: https://lnkd.in/ejejbXSk #OrderTrackingExperience #EHR

9

  Life sciences industry routinely faces inconsistencies and challenges in managing diverse data standards and output templates, leading to process inefficiencies. TCS ADD Metadata Repository platform provides automated and integrated solution that is easy to configure and provides compliance to industry clinical and regulatory standards. The platform leverages AI for intuitive mappings, real-time data availability and impact analysis, enabling digital data flow across the clinical value chain by leveraging Standards. Here are some snippets on the significant progress, in terms of functional features and technology innovation, in our TCS ADD’s MDR platform.   - Our MDR has been evaluated by multiple Sponsors as Industry most advanced & Leading Clinical MDR in Industry - Last year, we have delivered the industry first and the fastest SDTM automation using TCS ADD’s MDR. Please refer to this article written by our partner >> Automating SDTM: A Metadata-Driven Journey - Earlier this year we have gone live with the another industry first auto-ADaM automation using TCS ADD’s MDR - Our MDR platform provides end to end data lineage and traceability from study metadata to SDTM and ADaM submissions making it the most comprehensive MDR platform with connected standards.   Our platform and our experts have been recognized at various forums. Here are some examples : - India Pharma Awards: TCS ADD™ MDR won two awards at the prestigious India Pharma Awards in extremely competitive categories - “Excellence in Ancillary Pharma Services” and “Excellence in Best Use of Technology”.  - PharmaSUG : Our Sponsor presented paper in PharmaSUG. https://lnkd.in/gYhfgnK2 Another interesting paper which was presented by TCS Product Manager, Prasoon Sangwan at the PharmaSUG https://lnkd.in/gHTN6SHF - TransCelerate Digital Data Flow “Day in Action” : TCS ADD™ is proud to be voted as one of the Top 3 Poster Presentations at this year’s TransCelerate Digital Data Flow (DDF) in Action that happened in New Jersey on October 20, 2024.” TCS presentation focused on how DDF automates the creation of trial design datasets using AI, large language models (LLM), and deep learning technologies. It also touched upon accelerating the generation of USDM (Unified Study Definition Model)-based SDR (Source Document Review) and how this can significantly reduce manual effort.          - CDISC US Interchange 2024 : TCS ADD™ presentation explored the importance of efficient connected metadata governance for smooth digital data flow in clinical trials. It highlighted how AI(Artificial Intelligence) and ML (Machine Learning) can transform metadata management by automating standards creation, ensuring traceability, and maintaining lineage between standards. https://lnkd.in/g_3H5CXZ #tcsadd #digitaltrials

28

1 Comment

Navigate your commercialization journey with confidence. Learn more about Inizio Advisory and their Navigator.ai platform.

7

In my opinion, Mosaic AI Gateway is the most important part of the Databricks AI stack. Why? It provides a unified service to access, manage, and govern AI, enabling enterprises to incorporate multiple models (potentially from different providers) to build a compound system. Consider a pharmaceutical investor relations presentation... Creating an effective chatbot that incorporates such a document may require multiple specialized models including a vision-language model (for color-coded charts); a model that excels at deterministic calculations (for math tasks); and a domain-specific model (perhaps for biomarker abbreviations). AI Gateway eliminates the need for multiple systems, allows for rapid experimentation with quality evaluations, and incorporates comprehensive guardrails to enforce safety policies and protect sensitive information. This capability is allowing customers to leave behind narrow pilot projects and move into enterprise production.

54