Solutions

SAS

Why Clinical Data Management Services?

Collecting, storing, and curating large amounts of scientific data is important for regulatory compliance. Greater aggregation of data, and its reuse, not only reduces the cost of clinical research significantly, but also accelerates the drug development process.

Specialized clinical data management services can enable the following:

  • Ensuring quality and integrity of clinical data
  • Compliance to global standards to ensure consistency of clinical data management
  • Adoption of specific technologies and best practices in data management

PRODUCTS/SERVICES:

  • Development of paper CRF/eCRF
  • Paper CRF printing and distribution
  • Paper CRF tracking
  • Double-key data entry (paper CRF)
  • Clinical database design and set-up
  • Deliverable clinical database is developed using CDISC SDTM standard
  • Data definitions are provided in accordance with CDISC CRT-DD specification
  • UAT in EDC systems
  • Management of electronically transferred data (Central labs, central readers, etc)
  • EDT specification
  • Reconciliation of transferred data against CRF data
  • Integration of transferred data into clinical database
  • Data validation
  • Query generation & resolution
  • Review of resolved queries in EDC systems
  • SAE reconciliation
  • Clinical database lock
  • Clinical database transfers (interim, final)
  • SAS datasets
  • SAS XPORT transport files
  • Maintenance of Web-accessed study-specific tracking systems (enrollment, CRF/query tracking

Why CDISC Standards?

CDISC is here to stay and the need for having a sustainable data standards strategy and execution plan is critical in today's regulatory environment. But compliance is only a small component of the value of standardized clinical and medical data. There is significant business value that can be driven from an effective clinical data standards approach. In fact, we believe it will play a critical role in establishing a Company as a leader in your targeted therapeutic areas by enabling mechanisms to gather and assess true clinical benefits and cost effectiveness in real-world settings. The ability of market leaders to leverage clinical data in three ways is proven to establish top Brands. The three areas to focus on are

  • Ensure superior evidence to make the case for clinical differentiation and value-based reimbursement and leverage investment in producing long-range efficacy studies that demonstrate broader health system savings through improved quality of life
  • Utilize "lifecycle" planning to drive top value for a drug
  • Take every opportunity to translate health economics, clinical benefit, and safety issues into simple messaging focused on the quality of life of the patient