COVID-19 Resources for Rapid Response Copy
Resources for Rapid Response
Multiple emergency interim measures from global regulatory bodies are evolving during the COVID-19 pandemic. In line with the FDA’s COVID guidance addressing disruptions to patients, researchers, and sponsors, Medidata offers virtual/decentralization capabilities to reduce patient burden, while enabling sponsors to remotely review/monitor critical activities consistent with Good Clinical Practice.
With the pandemic, it is imperative to understand how to navigate, adapt, and implement changes to mitigate the risk of your trial.
This Resource Center provides recommendations for challenges described in “COVID-19 and Clinical Trials: The Medidata Perspective,” as well as access to our experts.
Understanding the Evolving Situation
Understanding the impact at the site and country level cross-sponsor will enable informed decisions when considering alternate countries and sites to ramp up.
Get up-to-date cross-sponsor trends in data entry, enrollment, and trial volume.
Reconsidering Trial Design to Enable Data Capture
Need improved understanding of safety in experimental treatments that are now under review for cross-indication use (e.g. Chloroquine). Need to address issues with closing out ongoing studies given barriers completing visits.
Leverage available synthetic control arm and synthetic control databases that provide aggregated and historical data to accelerate research.
Maintaining Supply and Quality
Travel restrictions for Sites, Sponsors, and CROs have negatively impacted on-site monitoring efforts. Post-COVID-19 data quality will require justification. New solutions are needed to minimize adverse impacts to patient enrollment and retention, as well as patient safety and clinical trial integrity.
Leverage Medidata’s automated data anomaly detection system, Centralized Statistical Analytics (CSA), focused on critical safety and endpoint data. Its flexible and rapid service delivery model enables you to automate study data quality reviews within 1-2 weeks.
Accelerating Study Start-Up
With COVID-19 investigator-initiated studies, there are often unwanted budgeting and negotiation delays due to the needed grant approval from the Sponsor and the gap between the Site’s and Sponsor’s individual cost benchmarks. Disparate data sources for clinical procedure activities and other direct costs at the investigator and site level can undermine decision making.
Medidata has developed a COVID-19 vaccination study budgeting solution, Rave Grants Manager COVID IIS, to help investigator-initiated studies develop and negotiate detailed trial budgets for patient, procedure, and site costs. Leveraging Medidata’s deep fair market value data and our clinical trial budgeting expertise, Sponsors can streamline the budget build process for their sites.