Clinical Trial Conduct Assistance

Keep your therapeutic development on track, even in our ever-changing landscape 

Advancing clinical trials through phase I-III is more complex and challenging than ever due to the ongoing COVID-19 pandemic.  At its onset, the outbreak quickly halted or delayed countless clinical trials, some of which are just beginning to restart now.  Additionally, COVID-19 restrictions have forced drug developers to rapidly change their approaches to conducting trials primarily by adopting virtual elements.  All these changes are decelerating the speed of clinical trials.

 

Our clinical trial support team understands that clinical trial delays can be catastrophic to you, your therapeutic. To give you an advantage Veristat has assembled a team of scientific-minded experts adept at driving trials forward even if it means pivoting to overcome challenges along the way. ​ 

 Adapting to Rapidly Changing Clinical Trial Norms

  • 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.
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Expertise From

600+ Rare Disease Projects

560+ Oncology Projects

250+ Infectious Disease Projects

100+ Cell/Gene Projects

30+ Covid-19 Projects

Adapting to Rapidly Changing Clinical Trial Norms

  • 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
   Clinical, Medical & Project Management Teams    Data and Statistical Teams    Regulatory & Medical Writing Teams
   Monitor and support the clinical trial sites with training,    Build, test, and deploy clinical trial database(s)    Informed Consent Forms
   Manage the study timeline, risk mitigation, and overcome the challenges that arise    Perform training for site data collection    Clinical Study Reports (CSRs)
   Provide safety management and reporting throughout trial     Rapid data cleaning for data review committees or interim analyses    Safety Narratives

 


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 

 

More Clinical Trial Conduct Support

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

 

Let's Talk. Get the right resources to keep your trial moving forward now.
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