It is unfortunate that EMA currently does not have a regulatory mechanism for accepting RWE as primary basis for approval. One can only wonder if things might have been different if this were 2025, after the EMA guidances are expected to be released. Hopeful that the FDA will recognize the strength and validity of RWE in their upcoming review! https://lnkd.in/gQddcAmr
Slipstream IT’s Post
More Relevant Posts
-
Slipstream Core Value #4 - We Freely Share Our Expertise Through CIO Engage, we share our knowledge and global network of industry leaders to help CIOs network and navigate technology in ways that foster their lasting impact. #lifesciences #biotech #slipstream
To view or add a comment, sign in
-
-
Slipstream Core Value #3 - We Address the Right Challenge Our teams provide deep technical expertise built over decades of service. We address our clients’ challenges strategically to create solutions, systems and services that drive lasting impact. Together, we turn the unique challenges our clients’ face into opportunities for progress and transformative growth. #lifesciences #biotech #slipstream
To view or add a comment, sign in
-
-
Slipstream Core Value #2 - Our Clients Always Come First We deliver what we promise because we are committed to our clients’ success. Our global delivery centers ensure 100% near-shore white glove service. We are wherever our clients need to be. #lifesciences #biotech #slipstream
To view or add a comment, sign in
-
-
Slipstream Core Value #1 - We Believe in the Power of Partnership We do what we do best because we believe in what our clients do best: Pioneering the next generation of life-saving medicine, technology, and knowledge. Because of this belief, we are a tireless collaborator, driven to provide scientists and technologists with industry-leading consulting, commercial solutions, and strategic IT outsourcing. #lifesciences #biotech #slipstream
To view or add a comment, sign in
-
-
Our team is hard at work continuing to develop major innovations this quarter. Here are 3 we’re excited about (in no particular order): 1 - Veeva Vault CRM Migrations As a Veeva Systems Premier Services Partner, our 100+ Veeva consultants are driving more and more transitions to Vault CRM, which we firmly believe to be the next generation CRM for the life sciences. Ashwin Girish Kumar & team are looking forward to connecting with many of you at the Veeva R&D and Quality Summit in September. 2 - DATAstream DATAstream is a fully outsourced, customizable hub built to integrate cloud applications and data in a single management platform. DATAstream functions as the center of your commercial data ecosystem, consuming data from the "source of truth" and publishing data in standard layouts to all consuming systems. Reach out to Keith Anastasi to learn more. 3 - Digital CRO Tracy Mayne & team are hard at work building the world’s first Digital Contract Research Organization. Ensuring real-world submissions meet the stringent standards of the FDA is neither easy or simple. Our team of experts creates and submits real-world evidence packages designed to ensure your submission is successful. #lifesciences #biotech #slipstream
To view or add a comment, sign in
-
-
4 reasons to love DATAstream: 👉 Real-Time Integration Seamlessly connect and integrate data from various sources in real-time, ensuring your team always has access to the most current information. 👉 Scalability & Flexibility Whether you’re handling big data or small datasets, DATAstream adapts to your needs with its scalable architecture. 👉 Enhanced Accuracy Minimize errors and improve data quality with our robust data validation and transformation features. 👉 Effortless Deployment Get started quickly with a user-friendly interface that simplifies complex data workflows and integrations. Learn more: https://lnkd.in/guSMtxwu #lifesciences #biotech #slipstream
To view or add a comment, sign in
-
-
3 ways you can tell a project is about to go sideways (and what to do about it): 1 - Lack of Stakeholder Engagement If key stakeholders show disinterest or dissatisfaction with project progress, it may indicate misalignment between expectations and deliverables. Frequent stakeholder engagement and feedback are critical. Tip: Schedule regular check-ins and feedback sessions to keep everyone aligned and invested in the project's success. 2 - Scope Creep If the project scope expands significantly without corresponding adjustments in resources, timelines, or budget, it can lead to delays and increased complexity. Scope creep often arises from unclear initial requirements or changing stakeholder expectations. Tip: Clearly define initial requirements and implement a clear change management process to manage evolving expectations. 3 - Missed Milestones or Deadlines Regularly missing key milestones or project deadlines is a clear indicator that the project may be falling behind schedule. This could be due to underestimated tasks, resource constraints, or inefficient workflows. Tip: Be realistic about milestones. If a deadline needs to change, communicate the at-risk assignment as early as possible so it can be mitigated. #lifesciences #biotech #slipstream
To view or add a comment, sign in
-
-
It’s never too early to start thinking about how to master your customer data. A proactive approach can help biopharmas avoid: 1. Complex custom integrations and increased costs 2. Difficulty understanding large health systems 3. Outdated and fragmented customer data Learn how to establish a scalable data foundation: https://bit.ly/4639Ckm #biopharma #lifesciences #masterdata
To view or add a comment, sign in
-
-
Protocols for submitting real-world evidence packages differ from traditional protocols in a variety of ways. For regulatory submissions, real-world data analyses must conform to the strict requirements of a clinical trial, including independent double programming. Programming code and algorithms submitted to the FDA must be well-documented, well-annotated, and complete enough to allow the FDA to replicate all study analyses and findings. Special thought must be given to those analyses unique to real-world data that traditional trial statisticians may not be familiar with, such as inverse probability of treatment weighting. Learn more in our full video series: https://lnkd.in/ghGG8G_Q #lifesciences #biotech #slipstream
To view or add a comment, sign in
-
When deployed effectively, Smartsheet can be an incredible time-saver for life science pros who wear many hats. Just ask our VP, Program Management Office Erica Breskin! Our pre-built Smartsheet templates enable accelerated adoption to create visibility across leadership and business partners. ☑ Right-sized solutions for small and emerging organizations ☑ Life science focus in R&D, clinical, and commercial functions ☑ Enabling consistent portfolio insights with lower administrative costs Learn more: https://lnkd.in/dtyfUMk #lifesciences #biotech #slipstream
To view or add a comment, sign in
-