INSIGHTS ON CLINICAL TRIAL TECHNOLOGIES

• Simplifying CRA Reconciliation: 5 Ways To Improve Site Visits

  CRAs are tasked with making sure all documentation and data is as it should be: current, compliant, and following the study protocol(s). Read how  with cloud-based web and mobile eTMF solutions, CRAs can throw away their spreadsheets and experience the following process improvements.

• Summary, Critical Details, And FAQ For Your TMF Management

  The EMA’s final “Guideline on the content, management, and archiving of the clinical Trial Master File (paper and/or electronic)” provides stakeholders with guidance on TMF creation, management, and archival. This overview summarizes and interprets the EMA’s “Guideline on the content, management, and archiving of the clinical Trial Master File (paper and/or electronic).”

• Top 3 Challenges Of Legacy Clinical Trial Management Systems

  Legacy clinical trial management systems aren’t built for today’s complex trials. Here are the top three challenges faced by sponsors and CROs when using a legacy CTMS.

• Implementing Study Amendments Without Downtime Or Data Migrations

  Companies can save time and money by implementing amendments in near real-time with Veeva Vault EDC. The benefits are considerable: the desired changes go into effect faster, administration costs are minimal, and downtime for sites is eliminated. Learn how your trials can become more agile in this white paper.

• The Good Data Submission Doctor: Should I Stay Or Should I Go?

  9/11/2019

  A recurring question we get from clients is whether it is worth adopting data standards such as CDISC in the early phase of their drug development, and if it is worth spending more to produce SDTM and ADaM packages at an early stage. Learn more about why this could be a good decision for your company and steps you can take towards adopting them.

• Remote Consent: Adjusting To The New Normal In Clinical Trials

  6/3/2020

  The global pandemic has brought the need to enrol new patients quickly in COVID19-related trials and keep patient engagement high in ongoing trials, even as face-to-face interactions are limited. This presentation will review sponsor and site frequently asked questions about electronic and remote consent capabilities as they seek to consent patients in new and faster ways.

• Building COVID-19 Studies In 5-10 Days With Vault EDC

  5/18/2020

  If you have a COVID-19 study, Veeva has built a template study that is fully validated and follow the new FDA guidelines based on CDC and ISARIC recommendations. This allows us to get your study up and running in days. Learn more.

• Tekton Research Experiences A 'No Findings' FDA Inspection

  2/5/2021

  As COVID-19 increased its impact on research collaboration and monitoring in 2020, Tekton Research’s desire to move to full remote monitoring intensified. The research site soon realized there was a need for a remote source document monitoring solution --– one that would enable the upload, management and sharing of source documents with monitors and sponsors without redacting sensitive patient information.

• How To Transform TMF Quality Guidelines Into Inspection-Readiness Habits

  2/3/2021

  To do inspection-readiness well and make it stick, you need a plan that goes beyond learning about the regulations and writing new procedures, more than developing metrics and creating dashboards, more than creating another online learning module. You need to consider human behavior and how we fail to develop habits that take care of our future selves, or in this case, our TMF deliverables.