Randomisation and Trial Supply Management (RTSM)
Venn Life Sciences Randomisation and Trial Supply Management (RTSM) is an in-house solution developed through the successful collaboration of our statistician, logistics and IT experts. Since 1999, our IRT has been used by our sponsors to centralise the randomisation of patients for their national and international Phase I to IV clinical trials, in addition to the logistics management of their studies. Our dedicated team focuses solely on delivering high quality IRT services.
Our Services include:
Methodological input
- pre-project consulting & consolidation
- complex models and simulations
- specification to avoid any methodological or unblinding bias
Patient & site management
- selection/randomisation/code break
- recruitment control
- alert system
- complex models of treatment allocation
- ePro capabilities
Logistics management (clinical supplies and samples)
- optimization of logistics models (following methodological constraints, availability, stability and cost)
- automated data upload from sponsor-selected central source (central laboratories, central pharmacies, EDC, ECG etc.)
Flexible, Adaptable, Cost Effective
- Continuous Monitoring (on-line reporting)
- 24/7 Support
- Available in 70 countries, 36 languages…so far!
- Available through internet and telephone
- Fully customisable to study specific needs
- High Quality Service at your fingertips
Regulatory Compliance
Our IRT system is regulatory compliant (21CRF part 11 – EMA & FDA inspected) and is developed and validated with a GAMP 5 approach.
Read about Planning a Clinical Trial? Here’s why Data Management matters – Click here.
Click to read more about Randomisation & Trial Supply Management RTSM/IRT.pdf
How can we help?
Contact your local office today and we’ll put you in touch with the key experts to help support your drug/medical device development program.