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| home > white papers > The Role of the CRO in Effective Risk-Based Monitoring - Medpace |
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 WHITE PAPERS |
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Medpace
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The Role of the CRO in Effective Risk-Based Monitoring
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The clinical trial industry is evolving. In an effort to improve
participant safety and data integrity, regulators are encouraging trial
sponsors to transition from a focused on-site monitoring approach they
have traditionally employed toward a risk-based approach that utilizes a
combination of centralized and on-site monitoring techniques to ensure
patient safety and data quality. The Risk-Based Monitoring (RBM)
paradigm has many potential advantages over established monitoring
practices including enhanced patient safety and data integrity, more
efficient and effective protocol design, reduced costs, and the ability
to strategically adjust oversight in keeping with changes in risk level.
Realizing the potential of RBM requires early planning,
analytical expertise, sophisticated tools and process adaptability. Deep
cross-functional expertise early in the trial process enhances the
ability to assess overall risk, define critical data and processes,
develop an integrated plan for addressing risk, and execute a monitoring
plan that meets the trial’s unique requirements.
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News and Press Releases |
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Live from Pharmapack: Pharmapack Drug Delivery Index hits record high
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White Papers |
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Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler
Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market.
Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.
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Industry Events |
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The Pharmaceutical Manufacturing and Packaging Congress 2023 (PHARMAP 2023)
12-13 June 2023, Hilton Geneva Hotel & Conference Centre, Geneva, Switzerland
The Pharmaceutical Manufacturing and Packaging Congress 2023 (PHARMAP 2023) gathers top-level management from pharmaceutical
companies of manufacturing, primary and secondary packaging, purchasing,
and supply chain and procurement sectors, CMOs and CDMOs leaders, heads
from government and institution on 12-13, June, 2023 in Geneva,
Switzerland.
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