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COVID-19 Resources for Rapid Response

COVID-19

Resources for Rapid Response

Emergency interim measures from global regulatory bodies are evolving during the COVID-19 pandemic. New FDA guidance is emerging to provide considerations ensuring patient trial safety and maintain compliance with good clinical practice (GCP).

It is more urgent and imperative than ever 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

Resources for Rapid Response

Understanding the Evolving Situation

Challenge
Understanding the impact at the site and country level cross-sponsor will enable informed decisions when considering alternate countries and sites to ramp up.

Solution
Get up-to-date cross-sponsor trends in data entry, enrollment, and trial volume.

Reconsidering Trial Design to Enable Data Capture

Challenge
According to EMA Guidance, points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials, “Data collection should preferably not stop and should continue as long as possible.”

Solution
Convert site-based data forms to remote data entry, provide remote eConsent option, and enable virtualization of visits and data capture as soon as possible.

Challenge
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.

Solution
Leverage available synthetic control arm and synthetic control databases that provide aggregated and historical data to accelerate research.
 

Maintaining Supply and Quality

Challenge
The potential impact on investigational product supply chain must be addressed before it becomes a reality. Patients engaged in a trial, particularly related to life threatening indications, need to have uninterrupted dispensation.

Solution
Use readily available technology to help manage your trial supply. Ensure that sites, patients, and depots are connected seamlessly. Achieve agile randomization and drive greater value and flexibility in your trial supply management.

Challenge
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.

Solution
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.

Challenge
Most sponsors are unable to monitor active studies on site, and may not be able to manage critical document management activities. Without the ability to securely manage these documents, patient safety and data integrity are at risk and studies may not progress.

Solution
Adopt a solution that supports critical document acquisition, management, and source review remotely via a secure, cloud-based portal. This will help to meet urgent timelines while ensuring collection, de-identification, management and review of critical study documents.

Accelerating Study Start-Up

Challenge
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.

Solution
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.