Pharma Lessons’ Post

Quality by Design (QbD) principles should be adopted by sponsors to smooth the transition to E6(R3). Customer identification is fundamental to quality by design. Read more in the article: https://lnkd.in/e9SFqufG While on the subject you may take a look at our free Good Clinical Practice Training: https://lnkd.in/eYcR-ix #pharmalessons #gcp #goodclinicalpractice #tmf #training #courses

Quality by Design (QbD) principles should be adopted by sponsors to smooth the transition to E6(R3). Customer identification is fundamental to quality by design. Read more in the article: https://lnkd.in/e9SFqufG While on the subject you may take a look at our free Good Clinical Practice Training: https://lnkd.in/eYcR-ix #pharmalessons #gcp #goodclinicalpractice #tmf #training #courses

Quality by Design (QbD) principles should be adopted by sponsors to smooth the transition to E6(R3). Customer identification is fundamental to quality by design. Read more in the article: https://lnkd.in/e9SFqufG While on the subject you may take a look at our free Good Clinical Practice Training: https://lnkd.in/eYcR-ix #pharmalessons #gcp #goodclinicalpractice #tmf #training #courses

Quality by Design (QbD) principles should be adopted by sponsors to smooth the transition to E6(R3). Customer identification is fundamental to quality by design. Read more in the article: https://lnkd.in/e9SFqufG While on the subject you may take a look at our free Good Clinical Practice Training: https://lnkd.in/eYcR-ix #pharmalessons #gcp #goodclinicalpractice #tmf #training #courses

Quality by Design (QbD) principles should be adopted by sponsors to smooth the transition to E6(R3). Customer identification is fundamental to quality by design. Read more in the article: https://lnkd.in/e9SFqufG While on the subject you may take a look at our free Good Clinical Practice Training: https://lnkd.in/eYcR-ix #pharmalessons #gcp #goodclinicalpractice #tmf #training #courses

🗂️🗃️What you know about the Trials Master File(TMF) 📌Trial Master File (TMF) is a compilation of documents. It ensures that clinical trials have been conducted following regulatory requirements (including Good Clinical Practice). 📌The TMF plays a crucial role in ensuring that the trial has been managed successfully by the Investigator, Sponsor and Institution. 📌The TMF is a requirement under GCP, and a list of Essential Documents that should be available before the clinical phase of the study starts, those that should be collected / added during the conduct of the study, and finally those that must be collected after completion or termination of the trial, is presented in part 8 of the ICH E6 Good Clinical Practice Guidance. 📌The TMF maintained throughout the trial.Available in paper, electronic (eTMF) and hybrid forms, the TMF should be available and accessible upon request. There needs to be one TMF for each clinical trial. 🔁When designing TMF: ▶️A minimum list of “Essential Documents” (which include the study protocol, investigator brochure, informed consent, trial insurance etc) is given in section 8 of the ICH E6 R2GCP guideline. This information can then be used in designing TMF. It is very important that TMF is very much a living repository, and new or amended documents will need to be added, and retrieved, as required.Also the security, definition of original records (e.g. if in special situations, electronic records may need to be used in place of hard copy), and archiving (when, where, how). 💻What is an e TMF The electronic Trial Master File (eTMF) is an application which leverages software and server technology to guide and assist the setup, collection, storage, tracking and archival of essential clinical study documents. The Benefits of eTMF 1. Setup Once, Reuse Many Times. 2. Remote Collaboration & Collection 3. Secure Storage & Archival 4. Ease the Tracking Burden 5. Standards, Compliance & 21 CFR Part #TMF #eTMF #Clinical Trial #Clinical Research #Trials #documents#ICH GCP

Adapting to the New LDT Final Rule: What Labs Need to Know The recent FDA final rule on laboratory-developed tests (LDTs) has sent ripples through the clinical laboratory community. As a leading medical billing and coding company, Commit Services is here to help labs navigate these new regulations and ensure seamless compliance. 📅 Key Dates and Changes: -May 6, 2025: Medical device reporting requirements come into effect, even for LDTs under enforcement discretion. -May 6, 2026: Registration and labeling requirements apply to most LDTs. 🔍 What Labs Need to Do: -Evaluate LDTs: Determine if your tests fall under enforcement discretion. -Prepare for Compliance: Develop processes for complaint intake, reporting, and quality systems. -Assess Financial Impact: Consider costs for premarket review, system upgrades, and regulatory compliance. 💼 How Commit Services Can Help: -Expert Guidance: Our team stays updated on FDA regulations to provide accurate billing and coding services. -Seamless RCM: We handle your revenue cycle management, allowing you to focus on compliance and quality testing. -Strategic Planning: We assist in financial assessments to help you decide which LDTs to continue offering. 🌐 Join the Conversation: Stay informed and prepared with Commit Services. Contact us today to learn how we can support your lab's compliance journey. support@commitservices.us +16463792144,+13473010812 #LDT #FDA #LaboratoryTesting #MedicalBilling #RCM #CommitServices

Transform your clinical trial management with a robust Electronic Trial Master File (eTMF) system! From centralized document management to real-time collaboration and automated workflows, an eTMF ensures compliance, efficiency, and audit readiness. Say goodbye to chaos and hello to streamlined processes! Ready to elevate your clinical trials? Learn how eTMF features can drive faster, more successful outcomes! #ClinicalTrials #eTMF #ResearchRevolution #HealthcareInnovationThe Essential Features of an Electronic Trial Master File (eTMF) for Clinical Trials https://hubs.li/Q02P36VF0

From last week's customer call notes: "Why would anyone use more than one #CDMS / #EDC system?" It's an interesting question. In theory, a single vendor allows for volume purchasing and, therefore, lower prices. In practice, Industry Standard Research's EDC benchmarking study reports that, on average, #sponsors and #CROs have preferred provider agreements with 2.4 EDCs. But those preferred EDCs are still only awarded 80% of the clinical research. Sponsors and CROs realize that their studies have unique needs that require unique capabilities, such as: - #HybridClinicalTrials, demanding a CDMS/EDC with eSource data capture (on a tablet or phone) capabilities - Primary endpoints based on patient-reported outcomes, requiring a CDMS/EDC integrated #ePRO for real-time patient outcomes reporting - #AdaptiveClinicalTrials, expecting mid-study changes or updates and requiring a flexible CDMS/EDC for rapid, efficient changes - #MedicalDevice, #Diagnostics, and #EarlyPhase trials, needing rapid, no-code CDMS/EDC builds - #CellTherapy and #GeneTherapy with expensive investigational products, benefitting from a CDMS/EDC with an integrated trial supply management (TSM) system

Transform your clinical trial management with a robust Electronic Trial Master File (eTMF) system! From centralized document management to real-time collaboration and automated workflows, an eTMF ensures compliance, efficiency, and audit readiness. Say goodbye to chaos and hello to streamlined processes! Ready to elevate your clinical trials? Learn how eTMF features can drive faster, more successful outcomes! #ClinicalTrials #eTMF #ResearchRevolution #HealthcareInnovationThe Essential Features of an Electronic Trial Master File (eTMF) for Clinical Trials https://hubs.li/Q02P36QX0