ClinFlo is a consulting and service company exclusively focused on the support and application of good technology for clinical research. We work with PharmaBio companies, CRO’s and Technology vendors to help ensure the best technology is applied in the support of clinical trials.
ClinFlo was founded by Doug Bain to address the problems of poor data in clinical trials. Doug believes strongly that better integrated systems applied in the right way will lead to significant improvements in clinical trial outcomes.
Computer Systems Validation CSV carried out by a vendor and by the consumer is essential. Today, the gold standard for is based around GAMP V Edition 2. This is a risk based approach designed specifically for Software-as-a-Service Cloud applications that are continuously updated and deployed.
Integration should improve both the quality and efficiency of software used in a clinical trial. Cleaner data faster is achievable provided the right steps are taken to achieve successful eClinical systems integration.
It is not just data that matters, it is the work that must be carried out to take data from raw / dirty to clean / ready. Optimized workflow achieves this with the greatest efficiency.
Read from our extensive series of articles that share experiences and knowledge on eClinical technologies - how to select, validate, implement and operate.
In 2025, around 70–75% of all drug trials (Phases I–IV) worldwide will be managed end-to-end by CROs under full‑service outsourcing (FSO) agreements—not just task‑based (FSP) support. That amounts to nearly three out of every four trials being fully entrusted to CRO …
Many readers may have heard of BioMedical Concepts (BCs). Some may also be aware of USDM — the Unified Study Definition Model, part of CDISC’s Digital Data Flow initiative. In this post, I’d like to share a few thoughts on …
The paper addresses the need to modernize regulatory frameworks for clinical trials, emphasizing that inefficiencies stem from outdated concepts rather than regulatory intent. It proposes eliminating the term ‘source,’ recognizing Trusted Third Parties, and embracing digital standards like certified copies. Additionally, it recommends a new ‘HyperTrial’ designation for technologically advanced studies and supports adaptive statistical decision-making in trials. These changes aim to enhance trial quality, reduce costs, and align regulations with current technological advancements, ensuring timely and efficient clinical research.
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