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LDC has over thirty years of experience working in the clinical data management arena on clinical studies spanning all phases and therapeutic areas. Our clients include Pharmaceutical, CRO, Biotech and Technology companies. Our flagship solution, Lab Data Hub, ensures delivery of clean data, meeting the specification, on demand, resulting in high quality data delivery that saves both effort and time.

LAB & BIOMARKER DATA

LDC data managers have worked with lab vendors across the spectrum of size, specialty and complexity. We provide technical expertise to devise and support data specifications and bridge the vocabulary and technical gap that can exist between sponsor/CRO and vendor.

Clinical trials are dependent upon biomarker data, both as end points for clinical trials and for determining strategic investment for future studies. Often, the lab vendors providing the necessary analysis are not well equipped to deliver the data to meet specification using validated methods.

LDC provides automated tools configured to the needs of the sponsor or CRO and lab vendors. Our Lab Data Hub solution ensures delivery of clean data, meeting the specification, on demand, resulting in high quality data delivery that saves both effort and time.

Additional services we offer include:

  • Data Transfer Specification (DTS) including the management of how it fits into current Metadata standard such as management of Codelists and Controlled Terminology
  • Vendor Agreements – creating and advising labs on how to review and negotiate terms
  • Secure data transfer account management and setup
  • Data extraction from LIMS and transformation programming to meet DTS
  • Custom automated solutions allowing lab vendor to go from PIMS extraction to validated data delivery to Sponsor/CRO with a single click

CLINICAL DATA MANAGEMENT

  • CRF & eCRF Design, Specification, Programming and Annotation including for CDISC Standards
  • Bedside data collection systems
  • Data Validation Specification creation, review and standardization
  • Programming, Validation and Testing of Edit Checks within EDC / Clinical Database systems including Medidata RAVE, Oracle InForm, IBM Clinical Development (formerly eClinicalOS), OpenClinica and Clintrial
  • Programming of Edit Checks external to the Clinical Database in languages such as SAS, Perl, Javascript, MS Excel (Macros), PL/SQL, SQL, Python and R
  • Query Management using EDC, Clinical Database and external data tools
  • Custom utilities for data cleaning and query management
  • Program management and facilitation, including negotiating data delivery needs with study team, Medical Monitor and Statistician
  • Managing the auto and manual term coding process
  • Data reconciliation (Lab, PK, PGx, PD, Biomarker, ECG)
  • Data extraction, transformation and loading (ETL) of study data as well as data external to the Clinical Database (Central/Local Lab data, PK, Biomarker, PD data) provided by vendor.

METADATA STANDARDIZATION

  • Configuration of Metadata Repository (MDR) and build of associated models
  • Creation of Processes for MDR and Metadata management and change governance
  • Build of validated custom utilities to leverage efficiencies available by the MDR

CDISC CONVERSION

  • Edit checks programmed in SAS, R or Python to validate data
  • Data transformation
  • Metadata utilization
  • Query management with EDC system integration
  • External data management for data obtained from outside vendors in dataset
  • SDTM Transformation

AUTOMATION

  • End-to-End (E2E) data standardization from protocol to submission
  • Auto generation of EDC database and related specification and validation driven by Metadata (MDR) and protocol for a study
  • Data ETL to meet CDISC standards or Sponsor/CRO specification in the case of lab data
  • Query management for data contained both in and outside of the clinical database
  • Electronic source data

CONTACT

Research Triangle Park, NC
919-399-9405
info@labdatasolutions.com