Newsletter | January 20, 2023

01.20.23 -- Best Practices For Risk Assessment Of GCP Vendors

 
     
 
     
 
 
 

Welcome to the Friday edition of the Clinical Leader newsletter, focusing on Clinical Data Management & Analytics and Trial MonitoringUpdate your topic preferences to receive additional Clinical Leader newsletters on:

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
 
 
     
 
Trial Monitoring
     
Best Practices For Risk Assessment Of GCP Vendors And Inspection Readiness
 
 

Requirements for risk management in clinical trials are outlined in GCP (R2) and provide you, as the sponsor, with the main steps for risk management in your studies. The implementation will vary from vendor to vendor depending on their delegated duties and functions. In addition to that, there are three other important considerations.

 
 
 
 
     
Integrated Clinical Monitoring: Technology Enabling Data To Talk!
 
 

When you think about integrated monitoring, what does that really mean? Learn how technology and monitoring fit together intelligently to reduce your workload within clinical trials. Find out more in the third blog within this RBQM series.

 
     
     
 
Clinical Data Management & Analytics
     
Embracing Agility In Phase 2 Clinical Trials
 
 

Phase 2 clinical trials are like software development. How so? Ivanna Rosendal explains the connection and makes the case for using a now-ubiquitous software development workflow to improve clinical data management.

 
 
 
 
     
Safety As A Science: Analytics For Trial Safety And Pharmacovigilance
 
 

From medical monitors and biostatisticians through safety and pharmacovigilance scientists, the need for timely and informative data analysis and visualization tools to facilitate in-study safety data review and more extensive pharmacovigilance (PV) is becoming more apparent.

 
     
There Is More To CDMS Than EDC
 
 

EDC alone cannot solve the data challenges posed by hybrid digital trials. Discover how this role can be taken on by also aggregating, cleaning, and providing user-based access to all trial data.

 
     
Achieving Adaptive Trial Success With A Unified Platform
 
 

Trials are becoming more complex in nearly every therapeutic area. While complex trials are important to getting treatments to market faster, they are challenging to design and conduct.

 
     
Medidata Link: Combining Patient-Level Clinical Trial And Real-World Data
 
 

Medidata Link is the only centralized technology solution that works across research sites to connect patient-level CTD and RWD.

 
     
MRN’s Decentralized Trial Data Handling
 
 
MRN’s eVRF (e-visit report form) is an electronic form tailored to match the needs of each clinical trial and used to capture subject and clinical data during the home trial support visit.
 
     
Cognizant Shared Investigator Platform
 
 

Cognizant Shared Investigator Platform (SIP) provides a single point of access for multiple clinical trial resources across sponsors and investigation sites.