Publications

White Papers (Free)

Case Studies

A Story often helps to better understand how companies have used MANA’s Services. These Case Studies demonstrate a variety of different approaches MANA has taken to support their customers. 

  • CRO implementation of Phase III trial: Phase III Dermatologic Study using MANA Method for Paperless Trials
  • Case Study— Quality, eClinical Trial Management—Knowledge Transfer
  • Case Study—Monitor Implementation of Remote Trial Management of Device Trial

     

If you are interested in reading these case studies, please complete the form below, and they will be emailed to you.

Published Evidence-Based, Data Driven Quality Operations Research

Original Research

  1. McPherson, EC; Ray, SC; Reiser, PA; Manasco, PK: Pharmacogenetic Research: Perceptions of Informed Consent; Drug Information Journal 36(1) 83-93, January 2002
  2. 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.
  3. 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
  4. Manasco PK, Herbel E, Bennett S, Pallas M, Bedell L, Thompson D, Fielman K, Manasco G, Kimmel C, Lambeth E, Danzig L, The MANA Method for Risk Based Monitoring is Superior to Onsite Source Data Verification for Trial Oversight in a Phase IV Pediatric Vaccine Trial

Opinion Articles

  1. Cerullo L, Radovich C, Ghandi IS, Wilder B, Stubbs C, Riley-Wagenmann C, McKellar R, Manasco PK, The Changing Role of the Study Monitor. Applied Clinical Trials  April 2014.  http://www.appliedclinicaltrialsonline.com/competencies-changing-role-clinical-study-monitor-implementing-risk-based-approach-monitoring
  2. Cerullo L, Radovich C, Ghandi IS, Wilder B, Stubbs C, Riley-Wagenmann C, McKellar R, Manasco PK, The Changing Role of the Study Monitor. Risk Based Monitoring in Clinical Trials 3rd edition.  Applied Clinical Trials  December 2014.
  3. Manasco PK: It Takes a Village to Achieve Risk-Based Monitoring.  Risk Based Monitoring in Clinical Trials 4th edition.  Applied Clinical Trials p. 12
  4. 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
  5. 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

Presentations and Posters

  1. Implementing a Paperless Trial for Phase III: A Biotech’s Lessons Learned: Integrating eSource, eTMF, and Clinical Monitoring to Generate Total Quality Metrics.  Drug Information Association 2013.
  2. The Paperless Trial: Technology and Processes for Success.  Drug Information Association 2013.
  3. Monitor Training: Building Essential Skills for Implementing Risk Based Monitoring—Data Interpretation, Quality by Design.  Drug Information Association. June 2014
  4. Site Satisfaction with using eSource (Session Chair). Drug Information Association. Drug Information Association. June 2014
  5. Implementing Risk Based Monitoring (Session Chair) Society of Clinical Data Management. September 2015
  6. Manasco G, Manasco PK: Expanding the Value of EDC for RBM and Remote Trial Management. Medrio User Conference. March 2016
  7. Manasco PK, Flack M, Riley-Wagenmann; Evolution of the Monitor’s Role without SDV and Onsite Regulatory Files.  Drug Information Association.  June 2013. 
  8. Manasco PK, Riley-Wagenmann C, Flack M; Remote Informed Consent Review: Results of Implementation in Phase III Trial.  Drug Information Association.  June 2013.
  9. Manasco PK: Electronic Investigator Site Files: The Hidden Gem that Completes Remote Risk Based Monitoring. Drug Information Association. June 2014.
  10. Riley-Wagenmann C, Manasco PK: Implementing a Standard Report Set for RBM Domains. Drug Information Association. June 2014