Data Management

Efficient and quality data management

Data Management has undergone a rapid evolution, and the tools and processes of the last decade are not enough to ensure high-quality clinical data anymore. Grounded in a foundational knowledge of clinical data management best practices, our experts have developed standards and tools to ensure the timely and accurate collection, receipt, review, and processing of project data. Although, we have standards and tools that we recommend using to realize efficiencies and quality, we also offer flexibility to meet the needs of the project.

Experience and availability

At Rho, our clinical data managers are engaged throughout the project, engaging in planning, execution, and delivery. They begin with the end in mind and work closely with the internal and external project team members to develop robust data management systems and ensure quality data. Alongside their individual experience, our data managers have direct access to internal subject matter experts and management which makes available decades of experience to every project.

Holistic Data Strategy

Data diversity and number of available data capture systems is increasing, and we can help clients develop a cohesive data strategy when it comes to data collection and integration. At Rho, we understand clinical trial data is no longer just subject case report forms.  We work with multiple sources of data and are experienced in a variety of commercially-available electronic data capture (EDC) systems, electronic clinical outcome assessments (eCOAs) including patient reported outcomes (PROs) and clinician reported outcomes (ClinROs), as well as third party vendor data and systems.

EDC

Rho is a Medidata partner and as such is able to utilize a number of Medidata’s offerings.  Our database builders are Rave certified, which enables us to build the project database in-house and achieve database in production by first subject in.  In addition to Rave, our data managers are able to support projects in other EDC systems.

eCOA

At Rho, we are able to utilize Medidata’s eCOA for the collection of ePROs and ClinROs which allows for seamless integration with the subject’s case report data captured in Rave.

Third Party Vendors

We also have a wealth of experience working with third party vendors to collect subject data captured outside of our systems like randomization and trial supply management, eCOAs, central labs and imaging.

Data from the third party vendor is integrated with data from EDC and other internal systems to provide a full account of the subject’s project experience.

Decreasing Time to SDTM

In keeping the downstream users of the clinical data in mind, Rho Data Management maintains a standard library of CDASH-compliant case report forms to both shorten EDC build times and expedite the transformation of EDC data into submission-ready SDTM.

Clinical Data Consulting, Evaluation, and Rescue

We can provide individual services or full-service data management.  We also offer project rescue, evaluation of project data management and consultancy services.

Our Data Management Services include:

Start-Up

  • Data management plan development
  • Database development
  • Edit check programming
  • User acceptance testing (UAT)
  • Third party vendor set up
  • Data review development

Maintenance

  • EDC user management
  • Data Collection
  • Medical Coding
  • Manual data review
  • External data receipt and reconciliation
  • SAE reconciliation
  • Query management
  • Report delivery
  • Rolling data freezes/lock

Closeout

  • Database finalization
  • Database lock
  • Final data transfer
Webinar

The Evolving Role of Clinical Data Management

Technology and data sources are rapidly changing, and clinical data management has to change too in order to keep pace.  This webinar will examine the effect of technology advancements on the future responsibilities of clinical data managers and discusses the needs introduced by the application of new technologies and broader data source availability.

Watch Now