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© 2021 MJH Life Sciences and Applied Clinical Trials Online. All rights reserved.
© 2021 MJH Life Sciences™ and Applied Clinical Trials Online. All rights reserved.
March 22, 2021
Identifying the ‘significant six’ areas of clinical study conduct to mitigate risk.
July 01, 2019
Exploring the use of electronic investigator site files for review of regulatory documents and informed consents.
June 13, 2019
Penelope Manasco, CEO of MANA UBM, answer thorny questions about adopting electronic investigator site files in clinical research.
June 11, 2019
Penelope Manasco, CEO of MANA UBM, disputes recommendations made by the original authors she finds to be problematic and worthy of further discussion.
May 17, 2019
CEO of MANA UBM, Penelope K. Manasco, explores the different approaches to determine what the right 'easy button' is to push to achieve effective clinical trial conduct and oversight.
January 30, 2017
With the new regulatory guidelines concerning GCP, questions have arisen as to how best RBM plans can comply. These questions and answers will assist sponsors in assuring compliance.
December 02, 2016
In a comparison study of source data review (SDV) methods, this new process demonstrates the value of using well-planned data visualization tools to provide better quality oversight versus remote eCRF review or onsite SDV.
June 01, 2016
Outlining those technologies best able to raise the data and process quality of risk-based monitoring.
May 17, 2016
A risk-based approach to quality trial oversight, adopted by the FDA and EMA, has resulted in an array of new technology solutions being released.