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EHR to EDC: The New Industry Imperative

Article EHR to EDC

One of the most resource-intensive, mundane, yet essential tasks in a clinical trial is the manual process of patient data entry. It usually includes transcription and validation of source data from an EHR or a pCRF into an EDC system’s eCRF. Thankfully, recent developments have created the need to expedite and streamline these clinical trial processes. Crisis Driving the Change … [Read more…]

Interoperability: The Evolution of Healthcare Within a Single Solution

Article Interoperability

Running a clinical trial relies on the simultaneous acquisition, storage, and recalling of copious amounts of data. In the case of intensively populated healthcare emergencies, new information is fed to the database every minute. Reviewing these data on a large scale requires synchronicity between multiple operating platforms and communication between their users. In a multi-centered clinical setting, data extraction alone … [Read more…]

Real-World Evidence and eSource in Clinical Trials

Real-World Evidence and eSource in Clinical Trials

What Is Real-World Evidence? Randomized clinical trials are operated under controlled conditions and are the fastest way of obtaining regulatory approval. However, they seek to answer the questions within a trial-defined frame and as such do not necessarily provide clinical relevance for the real-world environment. Real-World Data in medicine is data obtained from many independent sources that follow healthcare outcomes … [Read more…]

What Is UMLS?

What is ULMS

Unified Medical Language System® (UMLS) is a coding system that facilitates communication between various medical vocabularies by integrating terminology, classification, and standard codes. Furthermore, the UMLS package includes associated software that aids the creation of more interoperable software and systems. In other words, UMLS is used for the development of computer systems that need to “understand” medical terminology across various … [Read more…]

SNOMED CT and LOINC – Two Foundations of Interoperability

SNOMED CT and LOINC

Novelty interoperable software systems use valuable sources of terminology in order to provide operational transparency and clinical proficiency. They breach the terminology gaps by integrating various medical vocabularies on a code-level. By synchronizing immensely populated medical databases in semanticity and syntax, interoperable systems provide more accurate assessment of clinical data. The core information needed for operating large-scale trials are the … [Read more…]

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…]

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