Clinical Trial Registration & Results Solution - Compliance Automation & Management

 

Virtify’s Clinical Trial Registration & Results Solution, Virtify CTRR, can help organizations along the development product path from registry to results to disclosure.

  • Clinical Trial Compliance: Comply with global clinical trial regulations in an efficient, consistent and predictable manner
  • Automate their internal workflow processes and data accumulation
  • Manage the external workflow with the agencies in a collaborative environment.

The Virtify CTRR is built on an open, extensible architecture that uses common underlying infrastructural and business components. Key elements of Virtify CTRR are:

  • Workflow management that guides users through the data entry, review, and approval process 
  • Data quality authentication of all clinical trial record and study results FDA submissions to ensure satisfaction of standards and the requirements.
  • Audit trial capability to monitor progress and status of all clinical trial listings. 
  • Facilitates timely and accurate disclosure of clinical trial data 
  • Enables consistency of data across the globe. 
  • Eradicates the error opportunities and increases timeline efficiency.

 

Regulatory Agencies and Organizations worldwide are increasingly requiring drug companies register clinical trials and provide the results information. This is to ensure greater transparency of the most current and accurate clinical trial information to the public. Various applicable laws and guidance’s from agencies (e.g. US FDA, FDAAA, WHO, etc.) have increased the liability and risk associated with non-compliance. The current internal process within companies to provide this information is manual, error-prone involving repetitive work with a high degree of risk and non-compliance.

Virtify’s Clinical Trial Registration & Results solution, Virtify CTRR, can help organizations comply with global clinical trial regulations in an efficient, consistent and predictable manner. Organizations can automate their internal workflow processes and data accumulation using the system as well as manage the external workflow with the agencies in a collaborative environment. The constant changes to these regulations are managed by the system ensuring compliance and insulation to the business users from these constant updates.
 

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