Remote Source Data Verification (RSDV)

Reduce your travel costs and increase the speed to detection of issues when you verify source data remotely.

What is RSDV?

Remote source data verification (rSDV) is where the verification of source data is done remotely, off-site via a centralized location and by a specialist team. It is possible for multiple site’s source data to be checked at a single centralization location instead of going to a particular site. This introduces us to the concept of centralized monitoring.

When centralized monitoring and an rSDV approach is considered, the focus is usually on certain sites such as; high recruiting sites, low compliance sites, and sites with predicted or previous protocol deviations/violations. Also it is common for centralized monitoring and rSDV to focus on data points related to primary end points, safety data and certain trial related processes.

Benefits of RSDV

With the challenges caused by the Covid-19 pandemic and the reaction of the regulatory authorities suggesting remote approaches and a more patient centric approach to studies, more and more trials are looking to remote technologies.

Spend less on CRA travel as you monitor clinical trials remotely. Your CRAs will be able to review study documents and source data from anywhere, at any time.

By conducting SDV remotely, you perform precluding steps to a risk-based approach to clinical trials with RBM and CSM techniques to improve data integrity.

Speed up the detection and resolve both ICF and CRF queries as you no longer have to wait for psychical source data verification and timely respond times between monitors, investigators and site personnel.

How to perform RSDV

Step 1

Site teams sharing redacted copies of trial related source documents with the centralized team/monitor, using mobile apps or other technologies like uploading scanned PDFs to validated portals with audit trails.

Step 2

Video review of records; site staff sharing their computer screen using a secure video conference application.

Step 3

Providing restricted remote access (read only) to trial participants’ electronic medical records (EMR).

How does RSDV work?

RSDV Step-by-Step diagram-tiny

Key features of our RSDV Application

Cloud based application
Protect patient data

21 CFR part 11 compliant

Identifying potential problem sites sooner
User friendly functionality 
Subsequent monitoring visits less disruptive & more valuable to the site and the sponsors

Key Features of our Centralized Monitoring Team

Experienced monitors with therapeutic, GCP & regulatory knowledge
Team led by experienced individuals in global conduct of clinical trials

Enabling Risk Based Quality Management

Our rSDV platform is also an enabling technology for companies to successfully introduce Risk Based Quality Management (RBQM) – and help to target monitoring toward higher risk sites, resulting in more effective use of on-site monitoring resources. As source data is verified (both traditionally and remotely), this creates input data for other software solutions for our statisticians and data scientists to detect outliers, anomalous or fraudulent data defined both within a monitoring plan inclusive of key risk identification (KRIs) and in additional issues that lie outside the defined KRIs.

Browse our additional remote monitoring resources

WEBINAR

Find out what it takes to develop a successful remote monitoring program

WEBINAR

Discover a cost effective alternative to traditional trial monitoring with rSDV

WEBINAR

Learn more about the core components of a Statistical Monitoring Report