CLINICAL DATA MANAGEMENT

We understand that data can change everything as quickly as the tides do, and we can compensate for the additional flow of data requirements. Don’t let poor data management rain on your gains!

K3-Innovations provides services including database set up, database lock, cleaning, and reporting. We are committed to delivering timely, accurate, and quality clinical data by using regulatory-compliant data management tools. Clinical Data Management is a process that is crucial to clinical trials because it allows for high-quality data by keeping the number of errors and missing data as low as possible and gathering maximum data for analysis. Having a successful clinical trial relies on having accurate data to make inferences in order to stay on track and on budget.

We have an inhouse proprietary software for our data management activities. We ensure that our team of experts are well versed in GCDMP guidelines, HIPPA regulations, CDASH and CDISC standards, ICH-GCP, and 21 CFR Part 11 compliant. Here at K-3 Innovations we provide these services to ensure that your clinical trial data is of high quality and they meet the CDM regulatory requirements

 

 

346.jpg
  • CRF development

  • Develop Edit Checks/UAT

  • Database design and build in multiple EDC platforms

  • Integrating IWRS with EDC as needed

  • Database User Requirement Testing

  • Data Management and Quality plan development

  • Adverse Events and medication coding

  • Serious adverse event reconciliation

  • Query management

  • Manual listing review for data quality

  • Database freeze and lock

  • Developing CDISC compliant dataset

  • Support DSMB, Interim and DMC meetings

  • Database User Requirement Testing

Get in touch with us today and let us know how we can help you