RSMS – Rescue Study Mitigation Services

The newest branch from PhSLA comes to you with an innovative approach, ready to bring your study back on track.
The seniority and solid experience from our group allow us to support particular requirements and work on unique challenges with efficiency, ethics and high quality, making proper use of our technological tools and devices to ensure data compilation and analysis on a timely basis.
PhSLA Operating Directors have vast experience on Pharma and CRO, deep understanding of Latin American Region and its cultural differences, and have managed innumerous therapeutic areas on different study phases as shown below:

RSMS

Rescue studies are often very challenging, but your Company may rely on different services and expertise from PhSLA senior team in the following areas:

  • Evaluation of all study phases to identify key or critical issues
  • Detection of issues preventing or delaying success
  • Presentation of an action plan to mitigate risks and bring the study back on track

With such experience, knowledge of the majority of sites and physicians, and excellent partnership with key opinion leaders in the Region, we can provide services on the following countries:

 Argentina, Brazil, Chile, Colombia, Peru, Mexico, Panama, Costa Rica, Domenican Republic, Guatemala, and Puerto Rico.

Example of services provided depending on the study evaluation and its phase:

  • Co-monitoring visits
  • Internal data review to ensure 100% of produced data meets ALCOA and ICH-GCP requirements
  • Risk assessment
  • Support and hands-on on study backlog such as electronic CRFs, monitoring visits, IP inventory
  • Site recruitment speed up (evaluation and implementation of improvement plans in critical situations or enrollment rates below expectations)
  • Ensure ICH-GCPs compliance (professional development, site training and corrective actions, when necessary)
  • Transition facilitator when undergoing changes on major vendors (CRO, critical sites, central laboratory, clinical supplies distributor)
  • Audits (audit process preparation, end sites or vendors audits)
  • Inspection readiness (preparation for Regulatory Agencies’ Inspections)
  • Regulatory support, including Start-up process