Data Management

Our Focus is Your Data

As with all great research, good data is the difference between success and failure, and facilitating the efficient collection and management of clinical data is our only focus. Together with our award-winning TEMPO™ clinical research software platform, we offer Data Management Services (DMS) that ensure clean, accessible, quality data.

Built on TEMPO™, our data management services are designed to ensure:

  • Flexibility to meet your study needs
  • Complete visibility and management throughout the project lifecycle
  • Affordable, flexible Electronic Data Capture (EDC) and Study Management software
  • EDC implementation best practices

“We turned to Clinipace Worldwide to serve as the glue to hold multiple clinical and regulatory projects together from a data management perspective. Having complete real-time visibility into study-level information is critical to our success.” 
– James O’Connor Vice President, Worldwide Regulatory, Quality and Clinical Affairs, Surgeons Ethics and Compliance, Small Bones Innovations, Inc. (SBi)

In addition to the services included within every TEMPO™ deployment, we provide skilled staff that conducts:

  • Project management to ensure data quality and successful study completion
  • Case Report Form (CRF) development
  • Site audits for data integrity
  • Clinical/Medical coding with industry standards (MedDRA, ICD, etc)
  • Data validation and query resolution using TEMPO™
  • Data cleansing and quality assurance auditing
  • Complete management of electronic data capture (EDC) audit database
  • Project-specific data dictionaries
  • Reconciliation of external data
  • Data preparation for statistical analysis including derived variable creation and SAS programming

Data (Quality) is the Difference

Whether it is an interim report or data lock at study end, what matters is quality data. We assure data integrity by adhering to validated standard operating procedures (SOP) throughout any project. Our time-tested data quality processes include:

  • Adherence to Good Clinical Practices (GCP) to ensure data consistency, quality, and integrity
  • Adaptive, single EDC and study management database
  • Data validation at the point-of-collection and automated data review
  • Flexibility to meet your study needs

Collaborative TEMPO™ eClinical Deployment

We utilize a team approach, with a dedicated Project Manager overseeing project plans, TEMPO™ implementations, staff deployment and client interface. Our commitment to your project includes:

  • Project plan ensures complete visibility
  • Executive sponsor ensures accountability
  • Collaboration ensures quality
  • Training ensures adoption
  • Project team ensures lifetime support
  • Account management ensures access

Clinipace’s technology and data management services allows us to provide our patients and families at the participating practice sites data-driven, evidence-based and reliable care tailored to their individual disease status and needs. – Dr. Richard Colletti, Network Director of the ImproveCareNow Registry, Vice Chair of the Department of Pediatrics at the University of Vermont and Associate Chief of Vermont Children’s Hospital