Software Validation

Emanate takes a risk-based approach towards software validation. Our team has experience working within clinical operations and understands the need to be flexible while validating clinical systems. We will ensure that compliant documentation is produced to support software validation.

We empower sponsors to select the services they need. Whether it’s a single task or outsourcing an entire project, Emanate is here to help.

Our services include:

  • Process optimization
  • Vendor assessments
  • Solution implementation
  • Training
  • Testing
  • Validation

Data Management

Emanate offers comprehensive data management services from study start to study lock. We have earned a reputation for delivering high quality and cost-effective solutions to fit your project needs.

Let’s face it, sponsors need to obtain regulatory approval as efficiently and as cost-effective as possible. Engaging experienced clinical data managers at the beginning of a study results in high quality data.

We empower sponsors to select the services they need. Whether it’s a single task or providing CRO data management oversight, Emanate is here to help.

Our services include:

  • CRF/eCRF design
  • Data validation checks
  • User acceptance testing
  • Data query management
  • Data listings
  • Data entry
  • AE/SAE reconciliation
  • Medical coding (MedDRA, WHO Drug)
  • Randomization
  • Device accountability
  • Data management documentation (data management plan, data transfer agreements, CRF guidelines)
  • Data management metrics and reporting