Adapting to Rapidly Changing Clinical Trial Norms 

Today, most drug developers face new challenges when running their clinical trials, including;Clinical Trial Conduct Expertise

  • Trial design modifications due to changing regulatory guidance in response to COVID-19
  • Dynamically changing physical site access restrictions
  • Adoption of virtual technologies such as telemedicine, eConsent, eSource, etc.
  • Slower than normal patient recruitment
  • Introduction of at-home patient visits, local labs
  • Mitigation of data gaps due to a growing trend of earlier patient withdrawal
  • Revising statistical analysis plans due to changing patient populations
  • Deploying newer site models, such as central site model, hybrid site models (mix of on-site and remote), and fully remote site models

These trends continue to change as local conditions shift. Our teams, overseen by our COVID 19 Taskforce, are sharing lessons learned and rapidly adapting to these shifting conditions for running COVID-19 and non-COVID-19 trials in the current landscape.

 

Essential Support During Clinical Trial Conduct

Operationalizing a clinical development plan is highly complex, unique, and requires close collaboration between an interdisciplinary team of regulatory, clinical, medical, statistical, data, safety, and scientific experts. Our teams ensure that the processes are in place to advance through phase I, II, and III trials, even when planned or unexpected challenges arise.


Phase I, II and III Clinical Trial Operations

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Clinical, Medical & Project Management Teams

  • Keep patient recruitment and retention on track
  • Monitor and support the clinical trial sites with training,
  • Manage the study timeline, risk mitigation, and overcome the challenges that arise
  • Provide safety management and reporting throughout trial 

Data and Statistical Teams

  • Build, test, and deploy clinical trial database(s)
  • Perform training for site data collection
  • Rapid data cleaning for data review committees or interim analyses
  • Convert data to CDISC standards during or after trial conduct

Regulatory & Medical Writing Teams

Accurately write all the clinical trial documents including

  • Informed Consent Forms
  • Clinical Study Reports (CSRs)
  • Safety Narratives
  • Clinical Development Plans
  • Investigator Brochure and Patient Information Leaflets

 

The Right Resources to Conduct Clinical Trials

With Veristat, you get the right resources to run your phase I, II and III clinical trials in the rapidly changing environment today. We are ready and equipped to help you solve all the challenges that arise as you try to keep your programs on track.  When you work with Veristat, you get:

  • A scientific-minded partner to navigate the unpredictable​, with regulatory, medical, and statistical insights
  • Quick adaptation of programs not performing
  • Learnings from other therapeutic development programs​
  • Confidence in patient safety, your clinical trial data, and accuracy of your endpoints​
  • An agile plan from first patient in through database lock 

 

Let's Talk. Get the right resources to keep your trial moving forward now.
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More Clinical Trial Conduct Support

Learn more about our specific clinical trial conduct services to keep your trial on track.