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What Is MedDRA and How Does It Work?

What Is MedDRA and How Does It Work

Medical Dictionary for Regulatory Activities (MedDRA) is a clinically-validated international dictionary of medical terminology. It is used for the classification of adverse event information associated with the use of pharmaceuticals and medical devices. MedDRA is also a sophisticated thesaurus of highly specific, standardized medical terms that facilitates the sharing of regulatory information for pharmaceutical products. It is used for registration, … [Read more…]

What is ICD-10?

What is ICD-10

ICD-10 is the global reference base for morbidity and mortality statistics used by many healthcare systems and researchers worldwide. Officially, its full name is the International Statistical Classification of Diseases and Related Health Problems, and it has been promoted and monitored by WHO since 1948. Today, it is considered as a global information standard for clinical care and research. Its … [Read more…]

Semantic Operability in Clinical Trials

Semantic Operability in Clinical Trials

Continuous workflow is of prime importance in clinical trials. However, it is often challenged with the communication gap between different medical databases and manual processes of data acquisition and validation. Input of data by hand on classical case report forms (CRFs) and retyping source information on Electronic Data Capture (EDC) templates is often resource-intensive and time-consuming. EDC systems are compliant … [Read more…]

Clinical Trials: Hard Decisions Just Made Easier

Clinical Trials: Hard Decisions Just Made Easier

The pathway from clinical trial setup to its successful completion requires resource intensive decision making on a daily basis. Trial planning, finance management, assigning key roles and responsibilities require knowledge, ingenuity, and grit. As we all know, this is a time-intensive and error-prone task. Furthermore, in a large multi-center trial, these decisions get even more complicated. In this case, true … [Read more…]

Cutting-Edge Patient Data Tracking for Better Outcomes

Cutting-Edge Patient Data Tracking for Better Outcomes

Running a clinical trial and monitoring its progression relies on accurate patient records. Patient recruitment alone can make up to 30% of the clinical timeline and patient follow-ups extend trial phases for years. We at niAnalytics facilitate this process with automation and real-time proficiency on all levels. Since the age of paper records, processing of patient data has burdened health … [Read more…]

Setting up an eCRF for your clinical trial in as little as 24h?

Setting up an eCRF for your clinical trial in as little as 24h?

Developing new therapeutics is a time and resource-intensive task. Depending on the disease and therapy, clinical trials can take six years or more. This process can be significantly streamlined and shortened. The goal of clinical trial managers and clinical operations teams is to complete clinical trials in a timely manner while following stringent and specific guidelines. Running a successful trial … [Read more…]

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