Novella Clinical understands the importance of building targeted data management solutions for each study – always with a focus on quality. We combine therapeutic expertise with the latest clinical trial technology for timely and effective data capture and value-added planning for study execution. Our dedicated team is comprised of experienced data professionals who fully appreciate the complexity and challenges related to delivering a quality database. During the past two decades we have fine-tuned these processes to deliver a unique clinical trial that brings our sponsors full transparency, smarter trial management and greater efficiencies.

Data Management Services

On average, our data managers have 10+ years’ specific industry experience

 

  • Full-service or independent data management support
  • eCRF design, specifications and completion guidelines
  • Protocol amendments, updates and eCRF revisions
  • Clinical data review using leading technologies
  • Coordinated data review with other functions, including clinical, safety and biostatistics
  • Vendor reconciliation for labs, ECG, imaging, etc.
  • Local lab normal coordination
  • SAE reconciliation
  • Medical coding of events, medications, procedures and therapies
  • Database lock and archival

Statistical and Clinical Reporting Services

On average, our biostatisticians and programmers have 15+ years’ experience in clinical trials

  • Full-service or independent biostatistical support
  • Protocol development
  • Randomization
  • Statistical Analysis Plan (SAP) development
  • Table, Listing and Figure (TLF) development
  • Specialized reporting, including:
    • DSMB/CEC reports
    • Annual reporting

Our depth of experience enables our team to effectively and efficiently create forms and case books for each trial – reducing queries, minimizing errors and fostering positive relationships with site staff. We also have an extensive catalog of forms, which serves as an important resource for executing study builds. These forms are delivered using industry leading EDC technology. And, because Novella processes were built with EDC in mind, we can adapt our model to support any EDC system you may choose.

EDC Systems

  • Oracle InFormTM
  • Medidata Accredited Services
    • Medidata Rave®
    • Medidata Balance®
    • Medidata Coder®
    • Rave Targeted SDV
  • IBM Clinical Development
  • BioClinica® Express

Supporting Systems

  • jReview®
  • Patient Profiles
  • Cognos® 8
  • Business Objects XITM