Our solution …

The power of Spinnaker comes from the breadth and combination of features that allows you total control at all times. It provides a secure method to maintain trial integrity with double blind trials while providing quick, easy access to screening, randomisation and blinded drug supply details…

Randomisation

The Spinnaker randomisation module is integrated right into the software so you have a one stop shop for randomisation, eCRF and your management tools. We have both a response adaptive randomisation module along with our traditional options using fixed or variable block sizes, stratified by location and one other variable … or send us your statistician’s randomisation schedule and we will integrate that into your project at no extra charge.

  • Randomise from any smart device
  • Treatment issue is integrated into randomisation
  • Need response adaptive randomisation – we have one of those!

Stock Control

Stay in control of your treatment inventory with our integrated stock control module. This puts inventory in the hands of your project manager. She can order stock, view shipments, transfer treatment between locations and view reports on supplies or expiry dates. The status of each stock item is tracked throughout Spinnaker for accurate reporting at any time.

  • Real time management of drug inventory
  • Less wastage as you manage drugs reaching their expiry date
  • Maximum use of available stock as you transfer excess treatment between locations

Audit Log

Who changed what – when and why! Your audit log gives you the satisfaction of knowing every database interaction is being tracked and logged.

  • Every change is written to the audit log
  • Every patient record has an associated change log
  • No waiting – issues are reported in real time

Reporting

Spinnaker reports are flexible and configured for your project.  From query reporting on events (e.g. SAE, AE & PD) to enrolment lists, Spinnaker has all the reports you need to monitor your study.

  • Real time reporting & downloads activated by you
  • Reports to monitor AND manage your trial
  • Interim reports available 24/7

User Management

Systems rely on people. Spinnaker links all its permissions and functionality to your users. From the moment they log in, they get an experience tailored to their location and access group.

  • Local, regional and global roles all integrated into Spinnaker
  • Users managed and invited to your study by the project manager
  • Add new roles anytime. Does your dietician or steering committee need access?

Compliance

Spinnaker complies with the Food and Drug Administration’s 21 CFR Part 11 Guidelines for Electronic Signatures (FDA 21 CFR Part 11).

  • All user actions are tagged in the audit log for possible future retrieval
  • We have a restricted online process for sign-off on SAE
  • Available 24/7

Flexible Options To Fit Each Study Design

The team behind Spinnaker tailor the software, database, forms and reports to give you maximum flexibility during design and setup.

Imagine if we could do clinical trials faster, better and cheaper!

We do!