RBM Knowledge Transfer:
Supporting Adoption of Risk Based Monitoring and Quality Management. This approach allows organizations to move beyond Source Data Verification to adopt the new ICHE6(R2) requirements for Good Clinical Practices.
Knowledge Transfer: Protocol and process- specific RBM and Remote Trial Management Team Training to enable organizations to adopt the new ICH E6(R2) Good Clinical Practice Requirements
MANA RBM supports organizations committed to designing and implementing RBM processes internally. We offer team training for an entire organization or for use on a single trial. This service includes team support through the risk assessment process (pre and post-protocol approval), design of comprehensive technology systems and study-specific reports using our proprietary tools. This enables rapid, remote review of data and documents that exceeds simply checking eCRF pages.
Selected References of MANA Method:
- Manasco PK, Adopting eISF for Remote Quality Oversight of Trials. Applied Clinical Trials July/August 2019 p. 12
- Manasco PK, Adopting eISF for Remote Review of Regulatory Documents and Informed Consents. Applied Clinical Trials June 13, 2019 http://www.appliedclinicaltrialsonline.com/adopting-eisf-remote-review-regulatory-documents-and-informed-consents
- Manasco PK, The Risks of KRIs in RBM. Applied Clinical Trials June 11, 2019 http://www.appliedclinicaltrialsonline.com/risks-kri-rbm
- Manasco PK, What is the Right “Easy Button” approach for Research Oversight and RBM ? Applied Clinical Trials online May 17, 2019 http://www.appliedclinicaltrialsonline.com/what-right-easy-button-approach-research-oversight-and-rbm
- Manasco PK, RBM Barriers to Adoption: The results of a 2018 Survey of Sponsor, CRO, and Technology Companies. Applied Clinical Trials October 11, 2018. http://www.appliedclinicaltrialsonline.com/rbm-barriers-adoption
- Manasco PK, Bennett S, Pallas M, Bedell L, Thompson D, Fielman K, Manasco G, Kimmel G, Lambeth E, Danzig L, Comparing Risk Based Monitoring and Remote Trial Management vs. SDV. Applied Clinical Trials online September 28, 2018. Published in the journal, Applied Clinical Trials in November, 2018.
- Manasco PK, Does your CRO comply with ICH E6? Applied Clinical Trials Jan 30, 2017. http://www.appliedclinicaltrialsonline.com/does-your-cro-comply-ich-e6
- Manasco PK, McKee C, Dacpano G, Manasco G, Pallas M, Finlay C, Galang S, White T, Erwin R, Danzig L Subject Profile Analyzing Risk Saves Time for Monitors Applied Clinical Trials, Dec 2, 2016 http://www.appliedclinicaltrialsonline.com/subject-profile-analyzing-risk-saves-time-monitors
- Manasco PK, Quality Remote Monitoring: The Tools of the Game. Applied Clinical Trials June 1, 2016. http://www.appliedclinicaltrialsonline.com/quality-remote-monitoring-tools-game
- Manasco PK, McKellar R, Riley-Wagenmann, Stubbs C, Ghandi, IS, Radovich C, Cerullo L, Wilder B, Competencies for the Changing Role of the Clinical Study Monitor: Implementing a Risk-Based Approach to Monitoring Applied Clinical Trials Apr 29, 2014.
- Manasco PK: It Takes a Village to Achieve Risk-Based Monitoring. Risk Based Monitoring in Clinical Trials 4th edition. Applied Clinical Trials p. 12