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Basket, Umbrella, and Platform Trials: What Is Their True Distinction

Article - Basket, Umbrella, and Platform Trials

When investigating multiple sub-populations in cancer trials, traditional trial designs don’t provide the infrastructure needed for diversification. In recent years, the framework of Master Protocols emerged as a reconciling concept. Master Protocols are becoming more popular in clinical trials, especially when investigating targeted anti-cancer therapies. There are several master protocol study designs and they are referred to as Basket trials, … [Read more…]

Master Protocols: New Considerations in Cancer Trial Design

Article - Master Protocols

Cancer research is gaining momentum, especially in the field of gene-targeted therapies. On the other hand, traditional trial designs fail to tackle the complexity of approving new cancer therapies. Luckily, new trial designs are emerging that seem to correspond to advancements in genomic sequencing of tumors. So far, these new approaches have accounted for the increased trial feasibility, more accurate … [Read more…]

The Key Statistical Operations in Clinical Trials

Article - The Key Statistical Operations in Clinical Trials

Anyone reading a published medical research paper or a clinical study will eventually stumble upon data-derived study conclusions. However simple the results might seem, they are actually a product of complex study-specific calculations, which are created through statistical operations. Statistical calculation is an integral part of any research and clinical trial, and is often performed by top-grade biostatisticians. In fact, … [Read more…]

Biostatistics in Clinical Trials

Article Biostatistics in Clinical Trials

Crunching numbers might seem like the least fun part of a clinical trial, but it is the most important! Now, considering the amount of data that is compiled in a clinical trial, analyzing it can be as complicated as the trial process itself. If not tailored according to a precisely defined data range, trial results can be inaccurate or even … [Read more…]

Blockchain Technology in Clinical Trials

Article - Blockchain Technology in Clinical Trials

Complex as they are, clinical trials often involve many different organizations, locations, and data sources. This makes virtually all stakeholders having trouble to keep track of their documents and data. Yet, regulations are getting even more tight, demanding meticulous documentation from all trial conductors. What’s more, all trial interventions could be auditable at any time! As it seems, the future … [Read more…]

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…]

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