Leveraging a depth of medical and technical expertise, Alimentiv manages end to end clinical trial safety processes and effectively supports all activities related to patient safety during a clinical trial.
Safety Strategy & Study Planning
An integral component of the study team, Clinical Safety professionals closely support and collaborate on the development and start-up of clinical trials.
Safety Management Plan & Other Quality Documents
All clinical trials undergo a thorough and detailed review of the safety processes and procedures that will be followed during the study. Alimentiv adapts its plans and documentation to ensure that the specifications of the protocol align with the regulations and guidelines that apply to the study.
Contribute to the safety components of clinical trial protocols to ensure that safety standards are met. Assist with Risk Management activities.
Training & Support
All stakeholders on a project are informed and trained on the procedures to be followed during the study as it relates to Safety.
End to end safety management for clinical trials.
Facilitating the resolution of safety issues that arise throughout the project lifecycle through timely communication with project teams and sponsors ensuring all stakeholders are promptly informed of safety-related findings.
Case Management Capabilities
Review of medical/drug terminologies, consent forms and SAE assessments to confirm that safety-related documents align with project specifications
Case Processing Workflow
- Receipt, Book-in & Triage
- Data Entry
- Medical Review
- Narrative Writing
- Quality Control Review
- Aggregate review
- Regulatory Reporting (SUSARs, DSURs, etc.)
SafetyEasy PV (Database)
Centre to Alimentiv’s safety system is the SafetyEasy PV database which provides the required functionality for efficient SAE management and reporting.
- 21 CFR part 11
- E2B R2/R3
- MedDRA & WHODrug Coding
- Supplemented by Alimentiv’s internal work instructions and procedures
- CIOMS, MedWatch, IND Safety Report
- XML, E2B R2/R3
- Line Listings (PSUR, PBRER, DSUR)
- Summary Tabulations (PSUR, PBRER, DSUR)
- Signal Detection
SafetyEasy PV (Database)
Helping ensure adequate safety oversight during clinical trials and increasing the reliability and poolability of trial data. Alimentiv’s cross-functional team including Clinical Study Management, Clinical Safety, Medical Monitoring and Data Sciences provides the following DMC services.
Clinical Safety and Clinical Data management identify events requiring adjudication for each DSMB meeting.
Per Meeting Activities: Forte
- Clinical Document Retrieval
- Patient Dossier Development
- Identification of Adjudicable Events
- Planning & Coordination of DMC Meetings
- Participation in DMC Meetings
- Post-Meeting Review & Meeting Minutes
- Communicate DMC Results to Sites
DMC Set-up Activities
- Charter Development
- Adjudication Form Development
- Member Selection
- Contract Development & Negotiation