Risk Based Monitoring (RBM) Implementation Tools
MANA RBM offers a suite of documents to enable you to adopt RBM and Remote Trial Management internally. There are two options:
- One-time fee for SOPs and Plan Templates needed to implement RBM.
- SOPs include Risk Assessment, Performing Integrated Clinical and Data Review, Issue Management, Project Management, Managing electronic Trial Master Files and electronic Investigator Site Files
- Yearly License fee approach provides access to an expanded suite of documents and includes all updates MANA RBM makes to the documents. In addition to the documents listed above, licensees receive:
- Updates on SOPs and new SOPs developed
- Work Instructions for all aspects of RBM implementation
- Plan Templates (e.g., Monitoring, Integrated data review)
- Specifications (and discount license fees) for technology system configurations that support remote trial management and quality by design (including Risk Assessment, Issue Management, Training Oversight, and eMonitoring Reports) that can be implemented on the data collection system of your choice.
- Reports including Key Risk Indicators and Triggers, Report Specifications for standard trial oversight
- Job descriptions
- Discounted consulting and license fees for designing Study-specific High Risk Data Element and Process reports (from the Risk Assessment) and the Subject Profile Analyzing Risk (SPAR).
- Discounts on training programs provided by MANA RBM including RBM certification
For more information on these programs, contact us at firstname.lastname@example.org.
White Papers (Free)
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.