Biotech and Med Device CRO

Faster trial execution
Cost effective trial resourcing
Quality data delivered on time

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Project management: Keep your trial on track

  • Map out the trial timelines from first patient in to database lock
  • Up to date on trial progress with a dedicated project manager
  • Real-time trial tracking and address trial issues as they happen
  • Constant communication between the sites, sponsor and other trial vendors
  • Cost management to keep the trial on budget
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Study setup: Protocol design, CRF design and Study Build

  • We can help in proof-reading the protocol and making sure that it is programmable
  • We have templates that can get you started with CRF design in a effecient manner. We can also make sure that it is CDISC compliant
  • Once the CRFs are finalized, we can build up your study in 2-3 week time frame (depends on the complexity of the study)
  • Use our proprietary CRF designer tool to collaboratively design and finalize the case report forms (additional charges apply)

Data management and Statistical analysis

  • It is the core of what we do, our goal is to get you submission ready data from day one
  • We are EDC agnostic, we support all popular EDC systems (Medidata and Oracle Inform etc)
  • We will set timelines for your project and stick to them - protocol finalization to first patient in, data cleaning metrics for sites, and finally last patient in to database lock - we will map all these out at trial start
  • Real-time trial dashboard, periodic data cuts/analysis and final database lock. All follow quality metrics set forth at trial start
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Clinical Trial Management and Monitoring

  • Remotely monitor trial data, resolve data issues in a timely manner
  • Train the sites on the study, and keep their trainings up to date
  • Troubleshoot site issues and collect data seamlessly
  • Keep open line of communication with the sites and resolve problems before they happen
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Real world data and Real world analytics

  • Analyze real world data and see how the trial data correlates with data from other adjacent clinical trials
  • Use generative AI tech to fish out insights that are not obvious with direct analytical techniques
  • Project out trial progression metrics before they happen, includes number and types of AEs, when is trial likely to meet its end points, and finally trial outcome prediction. These can be analyzed and viewed by DSMBs in a sandbox
  • Use AI models to design more efficient future studies
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