Careers

Quick Facts

  • Quality Management System
    • Complies with ISO 13485:2003 and holds Certification: FM572840
    • Data systems are 21 CFR Part 11 Complaint
  • Industry-leading Tools
    • SAS® software
    • Integration to Medidata Rave®
    • WinNonLin
  • Data Center
    • We meet all of Tier 3* ~ TIA-942 Standards
    • HFC-125 Dry Fire Suppression systems
    • Secure location and access, including video surveillance
    • Fully grounded floor and rack system
    • Redundant power input with power conditioning
    • Full UPS power supplied to data center with emergency generator backup
    • Redundant cooling and ventilation system designed to maximize airflow

*No Raised Floor Flexibility

Services

Spaulding Clinical Research 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 & 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 - SDTM)
  • Biostatistics & Programming
    • Sample size calculations
    • Treatment randomization 
    • Statistical analysis plan development
    • Interim analyses
    • Statistical consulting & Trial designs
    • Summary tables, listings and figures and Listings (TLFs)
    • Integrated Safety Summary (ISS) 
    • Integrated Summary of Efficacy (ISE)
    • ADaMs (Analysis Data Model) CDISC compliant format
  • Pharmacokinectics & Pharmacodynamics
    • Noncompartmental PK & PD analysis
    • Toxicokinetic analysis & Bioanalytical data review
    • PK reports
    • Population PK analysis
  • Medical Writing
    • Protocol preparation
    • Fully integrated clinical study reports
    • Patient narratives
    • Standard Operating Procedures (SOPs)

Frequently Asked Questions

Flexibility is great, but how can we be sure Spaulding Clinical can deliver the data in our required format?

  • Detailed specifications are created at the beginning of the project and reviewed and approved prior to database build
  • Once specification is approved, the systems are built and custom export programming completed
  • A test export file is generated with mock data and sent to the customer to assure that there are no surprises upon study completion and that the data format is as expected
  • Full time programmers on staff are well versed in numerous export data format types, including SDTM and CDASH compliant data with capability of providing SAS transport files

How do we know if your EDC system will be able to utilize our standards for data collection?

  • Our data team is involved from the onset of the project
  • Our team works closely with you to ensure your data collection standards are met
  • Our EDC system provides the flexibility to create custom data collection windows based on your data collection and reporting requirements, so we can meet your needs no matter how unique or specific they may be

Will using an EDC system really decrease the time to database lock?

  • Absolutely – By utilizing our EDC, time-consuming transcriptions and costly reconciliation of data entry errors become things of the past
  • Our EDC and Database are one in the same, allowing us to perform programmatic data checks during actual study conduct
  • By performing the data checks during study conduct, most if not all queries are closed prior to the last patient visit
  • The combination of up front involvement of our data team, comprehensive project management throughout, innovative acquisition technology and a flexible EDC and Database can take weeks or even months out of the overall process

Can your EDC system integrate with our data management system so all our clinical trial data is in one system?

  • An example of an electronic data integration is an 88-Subject Phase I study that required all Rave defined parameters to the sponsor's Medidata Rave system
  • The transfer included 123,424 data elements with 559,508 characters
  • Using the traditional industry model, manual transcription of the study from the EDC system would have delayed the study transfer by 6 weeks and cost more than $25,000 in staff and monitoring time
  • Electronic data transfer was completed within minutes of the approval to transfer and included all Rave defined study parameters

Our data is everything... what assurances do we have that it will be properly protected?

  • We take data security and recovery very seriously; data backup systems utilize electronic monitoring and notification to assure all backup jobs run as scheduled
  • We leverage the latest commercial backup disk imaging solutions which allows full server backups to co-locations multiple times a day
  • Disk imaging provides the ability to restore systems within 90 minutes of a system failure utilizing bare metal restore or Virtual Machine (VM) technologies
  • Regularly scheduled testing of the data backups includes the full restore of the server OS and data verification
  • Access to data is secured via password over VPN with audit trail; all data is 128 bit encrypted

Spaulding Clinical Data Advantage

Place your next study with Spaulding Clinical and experience the Data Advantage that 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 subject assessments
  • Built-in data checks performed during study conduct so query generation is significantly reduced.
  • The flexibility to configure study data the way you want or recieve a Spaulding Clinical standard data output
  • Tableless, listing and figures delivered in RTF or PDF format to meet study timelines
  • Clinical Study Report(CSR) created per ICH quidelines with integrated PK results
  • ECG analysis and Expert report provided by world-renowned Cardiologist

 

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