ClinOne   ARK          QuARK  Care+     
  ClinOne  
     
 

Introduction:

Pharma/biotech and CRO organizations involved in clinical development of generic and novel drug products are constantly challenged in their endeavor to ensure study volunteers safety and compliance with regulatory requirements. Towards achieving this end, organizations are faced with-

  • Improving operational efficiency by optimizing utilization of resources and available infrastructure
  • Efficient management of processes that are highly variable and time consuming, namely, volunteer management
  • Synchronization between various departments including trial operations, medical and data management teams
  • Meticulous documentation of clinical trial process in line with regulatory guidelines, essentially making the trial transparent and auditable

Additionally, regulatory environment is undergoing extensive changes and authorities are increasingly recommending that marketing applications be submitted electronically.

  
 

Features:
  • Volunteer Management & Recruitment:

    • Robust volunteer management module enables easy systematic screening and recruitment of volunteers. The subjects may then be enrolled into a specific study or be enlisted in the ClinOne volunteer database. Volunteer database facilitates quick and speedy recruitment and study execution on “need basis” significantly cutting down study timelines with new projects and clients. In addition, unique biometric volunteer identification improves efficiency and removes repetition inherent in recruitment process.
 
ClinOne and ARK
  Automates BA/BE studies and Phase 1 clinical trial operations.

  Automates Clinical trial sample and Lab-Management.
  Interfaces with third party data management software.
 
 
  • Study set-up and Execution:
    Study can be set-up easily and executed based on the protocol design. Study personnel and other resources can be allocated optimally based on the availability and requirements. Study execution is automated so that each event is time stamped allowing for transparency and ensuring compliance. Data for drug dosing, sample collection and study monitoring are captured electronically and managed in compliance with regulatory requirements thus making the study easily auditable.
  • Integrated sample and Laboratory Management:
    Completely automates sample and laboratory management. Complete suite of ClinOne with ARK makes sample processing, storing and tracking easy and synchronized. Dispatch lists and labels are automatically produced for shipment of samples to the central laboratory. ARK provides readily available interface to integrate with industry standard third party products like SAS.
  • Report Generation:
    ClinOne enables generation of customized reports which are published as Adobe files.
  
  Highlights:
  • Volunteer Screening and Recruitment.
  • Scheduling and Planning.
  • Sample Collection and Management.
  • Complete report generation.
  • Event Tracking: Adverse and Serious Adverse Event Tracking.
  • Regulatory Compliant and Auditable Data.
  
   
© 2008 Deciphar Life Sciences