TRIAL MANAGEMENT
Cognitive, Pharmacodynamic Testing During FIH CNS Trials
A comprehensive review of optimal timing and methodologies for cognitive and pharmacodynamic testing during first-in-human trials on CNS-active compounds.
Webinar: Reimbursement Methods For Sustainable CGT Business Models
Learn more about the key features of successful innovative pricing and reimbursement models as well as outcomes-based agreements and the ways to advance those strategies for cell and gene therapies.
Solving The Impossible In Glioblastoma With An AI Synthetic Control Arm
This video discusses Medicenna’s MDNA55-05 clinical trial; a single-arm, open-label, multicenter study that offers a promising opportunity to improve outcomes for recurrent glioblastoma.
Are Your Clinical Study Meetings Building Momentum, Or Wasting Time?
Transforming passive clinical trial meetings into active catalysts for success, aligning teams and accelerating timelines.
TMF Management In Clinical Trials
Elevate your knowledge of clinical trials and the Trial Master File by exploring three critical topics.
What Is The Secret To Ongoing TMF Health?
Delve into specific tactics clinical teams can utilize for establishing immediate and long-lasting improvements to their TMF business processes.
Ensuring Compliance In Gene Therapy Trials: IRB And IBC Views
Explore ethical and regulatory challenges in neurological gene therapy trials, with expert insights on IRB/IBC collaboration, consent protocols, and oversight for vulnerable populations.
Clinical Trials And TMF 101 Learning Series: 2nd Session
The “Clinical Trials and TMF 101 Learning Series” kicks off it’s second session with three industry experts, that goes through some of the basics of clinical trials.
Cohort Configuration Feature Of An RTSM Platform
Master trial agility by building and prioritizing cohorts in real time. Effortlessly manage dose levels and enrollment limits to keep your study on track, even as protocols evolve.
Ensuring Completeness, Accuracy, And Consistency From Source To Archive
Discover how proficient TMF handling can proactively address potential pitfalls, fostering a state of preparedness for regulatory evaluations.
End-To-End Clinical Data Flow
Explore the interconnected data flow across Veeva Vault EDC, Veeva CDB, Veeva RTSM, and Veeva ePRO to visualize how these products work together seamlessly.
Defining And Implementing The Right Oncology Digital Strategy
A panel of oncology experts shares how top life science companies are using a combination of DHTs, ePROs, clinical trial platforms, and more to ease oncology research and drastically reduce timelines.
Clinical Trials And TMF 101 Learning Series: 1st Session
Spark a deeper and broader understanding of the world of Drug Development, Clinical Trials, Regulations, the Trial Master File, and much more – for the industry novice as well as the guru.
How To Boost Disclosure Efficiencies With Outsourcing
In this webinar, you’ll hear about exciting new advisory and managed disclosure services from TrialScope, including: compliance, policy and process assessments, as well as plain-language summaries, protocol registration, results posting, and redaction services.
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The Path Forward, Altasciences' Approach To Project Management
Learn about a unique, integrated program management strategy that can lower your costs and reduce program timelines from lead candidate selection to clinical proof-of-concept by up to 40%.
Digital Physical Activity Measures In Phase 3 Immunology Trials
Dr. Jie Shen, Research Fellow and Director of Digital Science at AbbVie, shares lessons learned from incorporating digital measures of physical activity into Phase 3 immunology clinical trials.
Accelerating Clinical Trials Through Streamlined Confidential Disclosure Agreements
In this presentation, Dr. Christine Senn addresses the persistent challenge of study startup delays by focusing on a primary legal hurdle: the Confidential Disclosure Agreement (CDA).
Say It With Technology: How Alnylam Fosters A Connected Relationship With Sites
Alnylam Pharmaceuticals is developing an entirely new class of medicines and delivered the world’s first and only approved RNAi therapeutics in 2018 and 2019. Learn how Alnylam earned its reputation among investigators as a sponsor of choice by standardizing studies...
The Difference Between Clinical Trial Auditing And Monitoring
While both trial auditing and trial monitoring have the same goal of protecting participant safety and rights, they are two separate yet important pieces of the clinical trial process.
Illuminating IHC: From Biomarker To Clinical Trial Assay
Through this presentation, Immunohistochemistry (IHC) expert equip you with the knowledge needed to effectively utilize IHC in your research and clinical practice.
Take A Look Inside The Pharmacodynamic Toolbox
This session explores the flexible selection of pharmacodynamic measures to enhance the pharmacology, safety, and efficacy evaluation of a CNS-active drug in early clinical trials.
The Real Payoff Of Reusable IRT/RTSM System Design
By utilizing consistent, repeatable system builds, sponsors gain significant advantages during protocol amendments and operational changes.
Korio RTSM Platform: Dosing Configuration Demo
Protocols evolve — and Korio is built to evolve with them. In this demo, see how users can easily add new doses, configure dose use rules, and define logic for dose adjustments based on visit history or other criteria.
Navigating Early Phase CNS-Active Drug Development
Early development of CNS-active drugs requires in-depth clinical expertise. Altasciences’ Dr. Beatrice Setnik, Chief Scientific Officer, examines the strategies to ensure early comprehensive data collection to fulfill regulatory requirements and aid in evaluating th...
Lack Of IRT/RTSM System Reusability Surprises Every Clinical Trial Sponsor
Stop re-learning your IRT system with every new trial. Uncover why "standard" features often hide custom complexities that slow down UAT and clinical operations.
Exploring The Principles Integral To Rare Disease Drug Development
This on-demand webinar offers valuable insights into successful rare disease drug development, including study design, regulatory engagement, and market access strategy.
Yes, Your Study Is At Risk: Risk Mitigation Plans For Endpoints
Ocular endpoints often introduce unique bottlenecks that can stall enrollment and compromise data integrity. This presentation provides the tools for a streamlined, resilient clinical trial strategy.
Learning About The Sensors In myMedidata
Learn how sensor data and advanced analytics can transform clinical research and enable your study to overcome data challenges, improving patient care.
Disclosure As A Service ROI
How do sponsors determine the ROI of Disclosure as a Service? TrialScope talks with two sponsors – a large pharmaceutical company and a smaller biotech – for their take on this. Watch the short video.