Study startup remains in focus, because it has still such an impact on clinical trials — and can be considered as part of the critical path to the success of a medicinal product. Any problem with the study startup, more than any other aspect of a clinical trial, draw a substantial risk to increase timelines and budgets.
HIGHLIGHTS
Collaborative Authoring
Trial Design
Patient recruitment, screening, and enrollment
Workflow management of the entire protocol's life cycle
The highest priority in terms of compliance while conducting clinical trials is protection of human subjects and patients. Compliance issues like protocol deviations or violations in the clinical trials remain an issue. Current findings in regard to trials conduct show the need for tools to endure quality and data integrity not only to fulfill the Code of Federal Regulations (CFR).
HIGHLIGHTS
Study conduct and project management
Monitoring visit reports
Close-out and analytics
Validated Reports, Ad-hoc reports
Clinical trial sponsors face many challenges in clinical trials – including how to mitigate risks that could cause delays and increase trial costs. What are some of the challenges that sponsors and CROs currently face when managing trial performance? How can sponsors and CROs use technology to overcome these challenges?
HIGHLIGHTS
Vendor Management
Investigator Management
Site Identification
Trial Planning and Startup
Site preparation
To comply with regulatory government policies, clinical research organizations need to keep records of essential documents that are stored in the trial master files (TMF). The TMF allows independent auditors and regulatory authorities to monitor and evaluate the quality of the data produced by a clinical study.
HIGHLIGHTS
eTMF integration
Archiving
Actual document statuses and updates,
Fully integrated with CTMS workflow events and triggers
For further information please contact us, we look forward to hearing from you.
