Clinical Research IO Software Addresses 50% Of Most Common Protocol Deviations, According To ClinPharm Network, Inc.'s Study

A new software system developed by Clinical Research IO (CRIO), a Cambridge, MA-based technology firm, has the potential to improve data quality in clinical research by up to 50%.

Currently, most clinical research sites capture study data on paper templates, and transcribe the data into various electronic data capture systems. The process is highly error-prone, leading to protocol deviations, data delays and redundant workflows.

CRIO’s software allows investigators to program electronic templates, then capture data quickly and accurately on a mobile device instead of on paper. The system has numerous safeguards to prevent data errors, such as pop-up alerts, skip logics, calculated fields, and informed consent version tracking.

A new study by ClinPharm Network, Inc., a leading quality assurance firm, has confirmed that CRIO’s system has safeguards that address up to 50% of the most common audit findings. ClinPharm Network, Inc. based this analysis by comparing the system’s features against the most common findings from a representative sample of its recent audits. To qualify as a safeguard, the CRIO feature had to be something that is not reproducible in a paper-based environment.

“Capturing data electronically is not only more efficient, but has the potential to improve data quality dramatically,” said Patrick R. Ayd, ClinPharm Network, Inc.’s President and Lead Auditor. “In our audits, we routinely find some very common issues, such as missed documentation, inconsistent data values or inaccurate time-stamps, which can be prevented easily by software systems that are appropriately designed. For these and other reasons, electronic source is definitely the direction the industry is heading in.”

This finding confirms the observations of sites that are utilizing the system. “Ever since we switched over to the CRIO system, we’ve seen our sponsor findings go down dramatically,” said Alex Wang, site manager of Beacon Clinical Research, a research site out of Quincy, MA. “Now, when we QA, we can focus on the important things such as the clinical data instead of worrying about all missed checkboxes.”

ClinPharm Network, Inc. (CPN) is a consulting firm dedicated to improving the drug development process. CPN consults with both pharmaceutical sponsors and clinical research sites to conduct pre-trial, interim and post-closing audits to improve adherence to Good Clinical Practices and study protocols.  CPN manages the Quality Assurance program for all types of small to mid-sized clinical trial sites.

Clinical Research IO (CRIO) is a technology company that launched the industry’s first 21 CFR Part 11 compliant e-source system aimed at research sites. Over 30 sites have signed up to use the system since its deployment in September, 2016, which is now deployed on over 20 studies. For more information about CRIO, visit www.clinicalresearch.io.