INSIGHTS ON CLINICAL TRIAL DESIGN
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.
Clinical Delivery Within COVID-19: We Have The Ability To Adapt
The clinical research industry has dabbled in the virtual space for some time now, cherry-picking low-priority studies to test artificial intelligence platforms and home healthcare nursing options. But today we find ourselves squarely facing the impossibility of continuing as we always have—as with the front-line healthcare professionals, we have to adapt immediately to a virtual environment to protect the well-being of research subjects.
Standardization Drives Transparency And Optimization Of Contract/Budget Processes In Clinical Trial Startup
For years, this laborious step has ranked as the lengthiest of study startup activities, and recent data suggest it remains the primary cause of site activation failure. This webcast will cover How granular metrics empower business intelligence, process optimization and efficient resource allocation and other steps to help avoid bottlenecks and delays.
Midlantic Urology Associates Introduces Added Convenience For Patients With Rideshare Program
Midlantic Urology Associates had been employing a single driver for all participant pick-ups. This proved to be inefficient and unsustainable, so they began utilizing taxis. This alternative was costly and unreliable – there had to be a better way. ClinCard’s integration with Lyft has not only improved the experience for patients and study coordinators but has also helped with recruitment as new patients are enrolling in the study as a result of this added convenience.
An Innovative Approach To Solve An RLD Shortage
Limited or no availability of the Reference Listed Drug (RLD) for a generic dermatology trial can seriously hinder the feasibility of a study. An innovative approach including the enrollment of patients with very high potential of protocol adherence and effective patient engagement to minimize the rate of retreatment throughout the study resulted in a successful study.
From Laboratory To Bedside: Expediting Development Of Novel Rare Cancer Treatments
This webinar shares new insights on rare oncology drug development and examines how new processes and regulatory pathways are helping speed development of novel therapies.
Key Considerations When Designing A Phase 1 Oncology Trial
Selecting a safe starting dose must be balanced against the proportion of patients treated at sub-therapeutic doses. This is especially important for agents that demonstrate minimal toxicity in preclinical testing or for drugs that are unlikely to ever reach maximum tolerated dose. This approach has the potential to reduce the number of dose escalations while preventing patients from being treated at overly toxic doses that lack incremental biological activity.
The State Of Patient (Dis)Engagement With Clinical Trials
Patient engagement is a big buzzword in the healthcare industry. Patient DIS-engagement, however, is the real challenge. See the statistics on where we as an industry are falling short when it comes to clinical trials.
Seven Essentials For Successful Drug Development
In reflecting on the differences between successful and unsuccessful clinical trials or programs, several factors consistently emerge as essential components of success and failure. This article reminds of the essentials so that effective therapies have a greater likelihood of reaching patients in need.
CLINICAL TRIAL DESIGN SOLUTIONS
Clinical Packaging (Primary)
Flexible, global and automated clinical packaging solutions.
Veeva Vault Study Startup Brochure
Veeva Vault Study Startup accelerates time to site activation by connecting global teams and enabling best practices for managing country and site start-up processes. Document-intensive start-up processes and milestone maintenance activities are managed in a single system, providing unparalleled insight and efficiency. And because Veeva Vault Study Startup works with Veeva Vault eTMF within the Veeva Vault Clinical Suite, study start-up and TMF content and data are seamlessly accessed across teams, systems, and studies.
Cytel has a strong track record in providing CDISC solutions and we are a CDISC Registered Solutions Provider. We have converted more than 150 studies as part of NDA submissions, all of which have been accepted by the FDA. The Clinical Data Interchange Standards Consortium (CDISC) devised the SDTM and ADaM models to standardize data structures for submission of raw and analysis data from clinical trials. These standard formats are increasingly expected by regulatory authorities including the FDA.
Comprehensive Enterprise Trial Management And Monitoring In The Cloud
Oracle Health Sciences Trial Management and Monitoring Cloud Service, comprised of Oracle’s Siebel Clinical Trial Management System (CTMS) enables effective management of critical clinical trial activities and improved relationships with investigators, from early to late-stage clinical trials. With real-time visibility into clinical trial progress and significant utilization rates of clinic and staff resources, this solution can help to lower costs, while increasing study speed and data quality. These services are part of the foundation for Oracle Health Sciences’ integrated, holistic approach to risk-based monitoring.
The only solution that offers both ride and reimbursement automation within one portal.