The pharmaceutical industry, not unlike many others, is full of acronyms. Some are industry recognized, others are specific to internal organizations. Most of the terms are just different flavors of the same thing. Understand why the term RTSM may accurately reflects the core function of the system as opposed to other industry used acronyms.
Know what questions to ask, and what benefits and limitations each approach offers the next time you are presented with the terms customization and configuration when it comes to RTSM/IRT (or any clinical systems).
The concept of NLP is not new, it actually has been around since the 1950s with Alan Turing’s publication of “Computing Machinery and Intelligence” which proposed what is now called the Turing test as a criterion of intelligence. We see the healthcare industry, namely hospitals, adopt NLP technology to improve the accuracy of electronic healthcare records (EHRs). What we haven’t seen, until now, is its application to clinical research to accelerate study start-up.
We’ve been seeing a lot of messaging around agility in Randomization and Trial Supply Management (RTSM) or as some refer to it, Interactive Response Technology (IRT). Is “agile” becoming the new “innovative”? Does everyone understand what it truly means to be agile with regards to software development? What about project delivery? Both are equally important, but we can argue that agile software enables agile project delivery and not the other way around (which has its limitations).
Chicago…our kind of town. Recently, it was also home to thousands of life sciences professionals, vendors, and experts attending the annual meeting for the Drug Information Association (DIA). TransPerfect has been a loud and proud participant in this conference for a long time. You couldn’t miss us if you tried.
With the quality of data captured throughout a trial playing a crucial role for the success or failure of a study, clinical data management (CDM) is a key element of any research program. CDM is the process of collecting, cleaning, and managing subject data in compliance with regulatory standards, with the aim of generating high-quality, reliable, and statistically sound data.
Ebola struck three West African nations in 2014, mobilizing the World Health Organization and bringing doctors from around the world to the affected areas. The following year, the Zika virus spread throughout major portions of Latin America. Events like these have led to calls for expedited approvals of vaccines and drugs undergoing clinical trials in order to nip these and future outbreaks in the bud.
Multi-country clinical trials have risen in recent years, and new regions have emerged as today’s most promising venues for clinical trials. The major forces behind these changes include the varying degrees of regulatory friendliness and access to patient populations in different countries around the world. Of course, cost plays a major role as well, as researchers have become increasingly attracted to developing regions where the cost of conducting a trial are considerably lower.
The European Medicines Agency recently published a draft guideline titled “Good Clinical Practices (GCP) compliance in reaction to Trial Master Files (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials.”
The ultimate goal of a template is to help investigators create high quality protocols that are consistent, well organized and contain all pertinent information needed to be properly reviewed.
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