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Data Management and Biometrics

A more flexible, efficient approach to data

When You Need Quality and Speed, Think Spaulding First.

As regulatory requirements evolve and your data submission deadlines decrease, your need for a partner that is 100% committed to your data deliverables is critical. Flexibility to manage your Phase I-III clinical trial data in a timely and fully integrated manner is what Spaulding Clinical is all about.

Our single repository of participant recruitment data, vital signs, lab results, ECG analysis, and statistical reporting streamlines the management of data, offers the freedom and flexibility to configure your clinical study data the way you want, and even lets you match segment population quickly, easily, and reliably.

Real-time access to results means you get higher quality data sooner and can quickly and cost-effectively adjust reporting parameters as desired.

We are a FULL SERVICE provider for Phase I-III clinical trials:

  • Protocol writing
  • CRF development
  • CDISC compliant E-source database build
  • Data management
  • Biostatistics and statistical design
  • Pharmacokinetics
  • CDISC compliant SDTM/ADAM datasets
  • Medical writing

100% paperless

A lot of CROs claim to be “paperless,” when in reality, that means they use some sort of electronic data collection some of the time. Spaulding Clinical has been 100% paperless since day one — exclusively using electronic data capture: we mean it when we say “paperless.” Our conduct reflects over 14 years of experience maximizing this technology’s accuracy and efficiency.

EDC eliminates variations in data measurement and analysis quality, saving our clients time and money. No other Phase I facility offers this level of commitment to paperless protocol execution — guaranteed.

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System Highlights

  • Seamlessly linked automation of monitoring, recording, analyzing, and reporting
  • Continuous digital data flow from site to submission
  • Fully GCP compliant
  • In-house QT analysis; multiple platforms and technologies
  • Six SigmaTM quality management principles for continuous improvement

This dedication to the ongoing betterment of everything we do — from our information management capabilities to our clinical technology solutions — enables us to give pharmaceutical companies data they can trust.

Services

Spaulding Clinical is revolutionizing the way clinical trial information is collected, analyzed, distributed, accessed, reviewed, and managed — saving time and ensuring high-quality study data.

Data Management

  • eCRF design and system configuration
  • Data management plan
  • Database design
  • Medical coding (MedDRA, WHODrug)
  • Electronic data transfer (EDT) to Medidata Rave® or other systems with open interface standards
  • CDISC compliant format (Study Data Tabulation Model, or SDTM)

Biostatistics and Programming

  • Sample size calculations
  • Treatment randomization
  • Statistical analysis plan development
  • Interim analyses
  • Statistical consulting and trial designs
  • Summary tables, listings, and figures (TLFs)
  • Integrated summary of safety (ISS)
  • Integrated summary of efficacy (ISE)
  • ADaM (Analysis Data Model) CDISC-compliant format

Pharmacokinetics and Pharmacodynamics

  • Noncompartmental PK and PD analysis
  • Toxicokinetic analysis and bioanalytical data review
  • PK reports
  • Population PK analysis

Medical Writing

  • Protocol preparation
  • Fully integrated clinical study reports
  • Patient narratives
  • Standard operating procedures (SOPs)
    • Project management
    • Medical monitoring
    • Rapid study startup
    • TMF management
    • Clinical site monitoring

Spaulding Clinical Data Advantage

Your next study can benefit from the Spaulding Clinical Data Advantage regardless of study phase, which includes:

  • A clinical information manager who is responsible for biometrics data from day one
  • A new degree of automation that eliminates time-consuming data entry and the potential for transcription errors
  • Test export file with formatted data sent to sponsor to assure there are no surprises
  • A single, highly integrated database that includes screening data, all vital signs, safety lab results, ECG analysis, dosing, and participant assessments
  • Built-in data checks performed during study conduct so query generation is significantly reduced
  • Custom-tailored data output, including the flexibility to configure study data the way you want view it
  • Tableless listings and figures delivered in RTF or PDF format to meet study timelines
  • Clinical study report (CSR) created per ICH guidelines with integrated PK results
  • ECG analysis and expert report provided by world-renowned cardiologist

Ready to partner with Spaulding Clinical for your Phase I study?

Let’s Talk