Certara’s Post

🚀 Exciting MedTech Transformation Update! 🌐 Key Highlights: 1️⃣ Unifying Clinical Data: Alcon and Illumina share insights on reducing manual effort and driving faster study builds through a digital approach. 2️⃣ Foundation & Training: Phased implementation and hands-on training were vital. Alcon focused on core solutions, while Illumina centralized their studies in-house. 3️⃣ Autonomy & Standards: Hands-on training at Alcon and rapid prototyping at Illumina led to system autonomy. Both implemented standards for efficiency, exceeding goals. 4️⃣ Takeaways for Leaders: Prioritize critical applications, ensure hands-on training, iterate on protocols, and define clear KPIs and goals for success. The Veeva MedTech Vault Clinical Platform is empowering partners to streamline processes and maintain clinical trial data integrity. 🚀 Explore insights from Leianne Ebert and Phil Tayco: 🔗 Leianne Ebert: Alcon's 4-Year Improvement Journey 🔗 Phil Tayco: Managing Data Sources with Vault CDMS Learn more about the Vault Clinical Platform. 💻 #MedTech #DigitalHealth #ClinicalInnovation

Read about industry leaders laying the foundation for a digital clinical infrastructure!

In modern #ClinicalTrials, good standardization practices are essential for boosting clinical trial efficiency, enhancing #DataQuality, and laying the groundwork for scalability. 👉 To see success with standardization, you need a training program that helps site staff understand your data standards and how to apply them. Read our blog for more expert-backed tips on standardizing your clinical trial data collection and generating efficiencies downstream: https://bit.ly/4aXAR1m

How Reliable is the Data in Your Clinical Research? 🧐 Elena A Christofides, MD, FACE l and colleagues recently published in the Journal fo Società for Clinical Data Management (#JSCDM) discussing the crucial comparison between Electronic Health Records (#EHR) and Electronic Source Data (#eSource) in clinical research trials. Key Findings: Data Integrity: EHRs often lack the rigor required for clinical trials due to inconsistencies and missing data points. In contrast, eSource provides a more structured and reliable dataset, enhancing data integrity and accuracy: authors highlighted that only 31.3% of medication records and 45.7% of medical problem are in concordance between EHR and eSource. Regulatory Compliance: #eSource systems are designed with compliance in mind, ensuring adherence to regulatory standards such as those set by the FDA and European Medicines Agency. This reduces the risk of data discrepancies and enhances the credibility of trial results. Efficiency and Accuracy: utilizing eSource in clinical trials significantly improves data collection efficiency and accuracy, leading to more reliable outcomes and faster decision-making processes. Practical implications? Data Validation: implement automated validation checks within eSource to catch discrepancies early, reducing the burden of manual data cleaning. Real-Time Monitoring: use eSource to enable real-time data monitoring, allowing for immediate corrections and ensuring data consistency throughout the trial. Integration with EHRs: develop integration strategies between eSource and EHR systems to streamline data flow and minimize data entry errors. Compliance Audits: schedule regular compliance audits to ensure that eSource systems meet all regulatory requirements, thus safeguarding data integrity and patient safety. What are eSource? Data originally and natively collected in electronic form as the source document; they can include original records and certified copies of original records, observations, or other activities captured prior to or during a clinical investigation used for reconstructing and evaluating the investigation. What are the implications for Clinical Trials? The adoption of eSource over EHRs could streamline clinical trial processes, reduce errors, and ensure higher compliance with regulatory requirements. This shift is pivotal for advancing the reliability of clinical research data and enhancing patient safety. By embracing more reliable data sources like eSource, we can pave the way for more effective and trustworthy clinical trials, ultimately leading to better healthcare outcomes. Link to the full article: https://da.gd/ehresource. What do you think about? Advice Pharma Group S.R.L. , Society for Clinical Data Management (SCDM) , ACDM: Association for Clinical Data Management

4am Software reseller of Certara Inc., desktop tools, including tools for Pharmacokinetics and Pharmocodynamics - Phoenix Winnonlin, Validation Suite, Phoenix Hosted etc please email for prices or free trial sales@4amsoftware.com.au or visit www.4amsoftware.com.au or www.4amsoftware.co.nz Repost of post by Certara below : Struggling to manage clinical trial metadata efficiently? A clinical metadata repository could be the solution. Learn how a CMDR can improve data quality, accelerate decision-making, and enable easier collaboration in our latest blog: https://ow.ly/m6cw50RmhiC #Certara #ClinicalTrials #PharmaTech #DataManagement #DrugDevelopment #ClinicalData #CMDR …see more What Should a Clinical Metadata Repository Do?

🔍 Unlocking the Power of CDISC SDTM: Understanding the Key Components 📊 In the realm of clinical research, data standardization is paramount for efficient analysis and regulatory compliance. CDISC (Clinical Data Interchange Standards Consortium) SDTM (Study Data Tabulation Model) stands as a beacon in this landscape, offering a structured framework for organizing and submitting clinical trial data. 🔹 Dataset Structure: At the core of SDTM lies its structured dataset format, which organizes data into specific domains such as Demographics, Adverse Events, and Laboratory Results. This structured approach enhances data consistency and facilitates comparison across studies. 🔹 Standard Variables: SDTM prescribes standard variables within each domain, ensuring uniformity in data representation. From baseline characteristics to efficacy endpoints, these standardized variables streamline data interpretation and support interoperability across systems. 🔹 Mappings and Controlled Terminologies: SDTM provides mappings to standardize the representation of clinical concepts across different domains and studies. By leveraging controlled terminologies like MedDRA and LOINC, SDTM ensures clarity and consistency in data interpretation. 🔹 Compliance and Regulatory Acceptance: Adherence to SDTM guidelines enhances regulatory acceptance and expedites the review process. By aligning with regulatory expectations, SDTM promotes transparency, reproducibility, and data integrity in clinical research. 🔹 Interoperability and Data Exchange: SDTM promotes interoperability by facilitating seamless data exchange between stakeholders, including sponsors, regulators, and researchers. This interoperability fosters collaboration and accelerates scientific discoveries. 🔹 Future-Proofing Data: Embracing SDTM future-proofs clinical trial data by aligning with evolving regulatory standards and technological advancements. By adopting SDTM early in the research lifecycle, organizations can mitigate risks and adapt to changing requirements. In conclusion, CDISC SDTM serves as a cornerstone for standardized data management in clinical research, offering a robust framework for organizing, analyzing, and exchanging trial data. Embracing SDTM not only enhances regulatory compliance but also fosters innovation and collaboration across the research community. Thanks, DM | Follow Rahul Vaidya for more information #CDISC #SDTM #ClinicalResearch #DataStandardization #RegulatoryCompliance #DataManagement #ClinicalTrials #Healthcare #ResearchStandards #CGM

Data-centric strategies such as Targeted Source Data Verification and Centralized Statistical Monitoring present a transformative opportunity to streamline the workload of clinical teams. These methodologies enhance operational efficiencies, improve data quality, deliver substantial cost savings, and expedite study timelines. Evaluating and quantifying the savings generated by these approaches can facilitate a comprehensive ROI analysis, promoting acceptance of these tools by the study teams and integration into your processes.

🧐 Have you explored the concept of data mapping and data flows? In our latest article, we delve into how these processes, when applied to clinical trials, can present unique challenges. Adopting a practical approach, we clarify: 📌The principles underlying data mapping and data flows 📌Key considerations and steps involved in executing these tasks 📌How sponsors can derive significant benefits from these activities, especially in meeting FDA and EMA requirements 📌Hands-on tips for effectively managing these processes 👨💻Our aim with this article was to move beyond theoretical discussions and provide concrete insights into the operational aspects relevant to clinical trial sponsors. We're eager to hear your thoughts and feedback! https://lnkd.in/dYNDeq3K

Did you know we have a Clinical Data Review Platform (CDRP)?  Take a quick look!   Every day, pharma companies may generate clinical data from over 30,000 patients participating in 150+ clinical trials at more than 10,000 sites. With data streaming in from all sides, clinical data reviewers (CDRs) often struggle with poorly integrated, duplicated, missing, or outdated information in a huge array of formats.   It’s time to put CDRs back in control of the data lifecycle, from startup to closeout.   Compiling, aggregating, and utilizing such a vast amount of data requires leading-edge, future-ready technology. Deloitte’s Clinical Data Review Platform (CDRP) allows organizations to dynamically manage data and solve for complexities in the clinical data review process. Reduce manual burdens by managing data review plan activities, including findings and observations, in a seamless and integrated digital workflow Enable collaboration across teams with real-time insight into queries, reviews, and other key action items Foster accountability and compliance by enhancing governance throughout the clinical trial lifecycle   Stay tuned over the next few weeks to take a tour of the CDRP platform and explore how we can accelerate success for pharma companies and bring value to every step of the clinical trial process   As always, feel free to contact me if you want to get more info! 

Budget constraints shouldn't hold back groundbreaking research. Discover how TrialKit by CDS makes clinical trial data management affordable without compromising on quality. Our comprehensive, scalable platform is designed for research teams of all sizes. Learn how we're driving innovation and accessibility in clinical research. Read the full story here: #clinicaltrials #clinicalresearch #datamanagement #EDC #eClinical