Jumping the Hurdles of Everyday Clinical Trial Challenges

Despite your team’s careful planning, unexpected road bumps can occur when a clinical trial is in the field.  We hope none of these happen to you, but here’s how a nimble RTSM would help you handle these situations.   Someone left the package out in the heat! Problem: Your drug must always remain within a …

Read more

Tracking Temperature Deviation with your RTSM

The ability to track the temperature excursions of an investigational product has become increasingly important in clinical trials. Temperature data logging devices are used to record the drug’s environmental exposure from the time it is sealed into a shipping container at the warehouse to the time it is unpacked at a clinical site. The electronically …

Read more

Why Flexibility is Important in Clinical Trials Supply — and how a nimble RTSM partner can help keep your trial on track.

changes in clinical trials can be challenging

Why is flexibility important to keeping a clinical trial on track? To illustrate this, let’s explore the Clinical Trial Supply Lifecycle using a fictional Sponsor named Pharzm who is running a Phase 3 trial for a new drug. Pharzm has a new two-year trial, which includes 200 subjects. They plan to manufacture 5,280 bottles of …

Read more

Testing Your RTSM for Your Next Clinical Trial

Regulatory requirements make the documented testing and validation of the electronic systems used in clinical trials critically important to the success of any clinical study. This is because approval authorities will reject clinical data collected by what regulators deem to be substandard means. (For examples, see 21CFRPart11 and EU Annex 11) There are two categories of project-level RTSM …

Read more

Managing Drug Returns with your RTSM

Drug accountability is important to gathering quality data as well as ensuring patient safety. The problems associated with it remain key issues for clinical trial management in 2022. Using an RTSM (IRT/IVR/IWR) system to manage the distribution and assignment of an investigational product (IP) is a well-established practice. Most RTSM systems include some method of …

Read more

Effective RTSM Startup Meetings – Tips for Sponsors and CROs

An RTSM system is the tool of choice for clinical trial subject randomization and management, drug assignment, and inventory control. The RTSM system is often the first point of entry for subject data before it is pushed to the EDC housing the clinical database. So when it’s time to hold the startup meeting with your …

Read more

Why being “Study-Team-Centric” Is Important in Clinical Trials

Give Your Clinical Study Team More Power! In the fast-paced world of clinical trials,  immediate access to information and the ability to adapt are critical.  That’s why Veeva RTSM advocates a “study-team-centric” model of clinical trial execution, where our system facilitates putting the study team in control. To be team-centric means to consider the basic …

Read more

What is the difference between an IRT and a RTSM system?

The Clinical Trials industry has seen its share of changes over the past 20 years (like many industries).  In case you are keeping score, or trying to keep score, this blog should clarify things a bit. IVR or IVRS (Integrated Voice Response System) is a tool used in the 1990s/early 2000s to call into a …

Read more