Clinical research, like any scientific research, entails many components and demands a plethora of skills. A clinical Investigator should be a master of knowledge in the specific field(s), constantly keeping up with the relevant developments and innovations. For the proposed drug, device or procedure, the Investigator should be able to develop an efficient and detailed …
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In general, increased industry costs are driving n to reflect on current practices in order to determine where efforts can be decrease in order to save costs. Many approaches have been investigated and implemented successfully without any compromise on data integrity. Risk based monitoring is one of these, it has drastically reduced the cost of …
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There is no doubt that our clinical trial designs are getting more complex by the day. This, however challenging, is a result of progression in the industry and is unavoidable. From a Data management (DM) perspective, the result is more complex CRF designs, more and highly complex edit checks and of course data source proliferation. …
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Published in Medical Writing Magazine, Volume 29 Number 2 | June 2020 Authors: Shiri Diskin, Tanya du Plessis, Ofra Barnett-Griness Abstract Analyses of integrated databases of efficacy and safety are a Food and Drug Administration (FDA) requirement. They are very useful in evaluating the safety and efficacy data gathered in multiple clinical studies. However, their utility is dependent upon the …
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No clinical trial sponsor intentionally plans a study migration. Sometimes the decision to migrate data from one database (or data collection platform) to another just can’t be avoided. Once considered a rarity, more and more sponsors are finding the need to switch vendors in the midst of a study. There are a host of reasons …
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Alongside data managers, statistical programmers and medical writers, biostatisticians play an integral role in the collaborative effort to develop new drugs and devices. And that’s because biostatisticians are involved in every step of clinical research – from study design to protocol development to data management and monitoring to data analysis and clinical trial reporting to …
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Regulatory submissions are the most critical milestones in clinical research programs. Quality submissions can accelerate time to market, maximize research investments and bring the benefit of new treatments to patients sooner. In August 2018, when the time came for RedHill Biopharma (Nasdaq: RDHL) to prepare its New Drug Application (NDA) for Talicia® (omeprazole magnesium, amoxicillin …
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In light of regulatory requirements, CDISC SDTM is now the leading standard for representing clinical data. Still, the use of SDTM poses many challenges. Since EDC systems can’t automatically generate SDTM datasets, converting the raw clinical data is a manual, lengthy and error-prone process. Additionally, the fact SDTM is set to support a broad array …
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Technological advances, providing better and quicker way for collecting increasing amounts of data, pose a challenge for data managers. With utilizing new technology being inevitable, and with all data processing activities being focused in a direction which requires less human review and more human oversight, how do we prepare our current work force to embrace …
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Growing amounts of collected clinical data augment the importance of reassessing the methods used for data processing and managing. Risk-based monitoring of the collected data is an integral part of any quality management program, it is an obligatory demand of the regulatory agencies and it substantially contributes to reducing the probability of costly failures (Hawwash, …
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As one stands in the booth hall of any conference on clinical trials, one will see an array of different technology vendors all looking to fill a space in the technology front of clinical research. Though the proposed new developments are not necessarily aimed to fill the same void, there is one specific area which …
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The hierarchy of scientific evidence is a concept from the field of evidence-based medicine. Most physicians strive to offer care that is grounded in scientific evidence, but while it is generally accepted that randomized controlled trials (RCTs) are the gold standard for support of a medicinal claim, the differences in scientific strength between other types …
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