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The recent evolution within the pharmaceutical industry to the use of technologies associated with clinical trial data collection and storage is quite impressive. Even the risk-averse clinical trial sites are [...]

At the October 2021 DIA conference on Digital Technologies in Clinical Trials, Pfizer reported the following timeline for the Pfizer-BioNTech COVID-19 vaccine clinical program: On May 4, 2020, the Phase [...]

Within the domain of clinical trials, the goals of quality by design (QbD) are to assure that the outcome data are fit for their intended purpose and that there is [...]

There has been a recent thrust within the pharmaceutical industry to promote the transformation of the clinical trial process. In 2008, the Clinical Trial Transformational Initiative (CTTI), a public-private partnership [...]

The pharmaceutical industry is a stellar industry that has contributed greatly to the health of individuals as well as to the public health. Just look at the rapidity that multiple [...]

[PEER REVIEW] In order to support the transformation of how the pharmaceutical industry manages the performance of clinical trials, in 2013, the Food and Drug Administration (FDA) issued its final [...]

Historically, clinical trial data were collected at the clinical research site on pieces of paper designated as Source Documents. These data were transferred manually by the site to paper case [...]

The advancement of new technologies and their adoption by the clinical community poses a challenge to regulators. The regulatory community is charged with ensuring safety and effectiveness and comes under [...]

Barriers to entry for implementing an Internet-based clinical trial (IBCT; a.k.a, electronic data capture, or EDC) were described by Kelly and Oldham, (1) and very early on, it became clear [...]

In the mid to late '80s, a tool called remote data entry was available which replaced double key data entry and paper case report forms (CRFs) at the clinical trial [...]

The development of timesaving processes that safeguard data integrity continues to be a primary goal of pharmaceutical companies. Remote data entry allowed the industry to improve the integrity of its [...]

A Tale of Three Trials As we enter the 21st century, Internet-based data collection, retrieval, and management are becoming the norm in drug and device clinical research. By increasing data [...]

Elevated plasma bilirubin (hyperbilirubinemia jaundice) may be found to some degree in about 60% of all neonates. In a small group of these children, it may progress to a serious [...]

In 'Flying Blind on CRA Workload, Time Demands,' in the July 2012 issue of Applied Clinical Trials, Kenneth A. Getz identified the current resource utilization to monitor clinical trials. Basically, [...]

Working closely and cooperatively with regulatory authorities during drug development is vital to successful drug development programs. In the United States, the drug development team includes not only members of the key disciplines of drug discovery, clinical research, regulatory affairs, marketing, chemistry, toxicology, and legal aspects, but also the Food and Drug Administration (FDA). New regulations encourage meetings at the pre-investigational new drug (pre-IND), end-of-phase-2, and pre-new drug application (pre-NDA) submission phases. Appropriate informal discussions via fax and telephone are also encouraged. By proactively interacting with the FDA, the pharmaceutical industry increases the probability of a successful drug development program.