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LDS has over thirty years of experience working in the clinical data management arena on clinical studies spanning all phases and therapeutic areas for some of the largest Pharmaceutical, CRO, Biotech and Technology companies.

Our experience includes work in the following specialty areas …

LAB & BIOMARKER DATA

LDS has data managers who have worked with lab vendors varying in size, specialty and dealing with just about every sort of data imaginable. We recognize that this experience and skill set is not easy to find. We combine the technical expertise necessary to devise and meet data specifications with the communication skills necessary to bridge the vocabulary and technical gap that often exists between sponsor/CRO and vendor.

Clinical trials are becoming more dependent upon biomarker data as end points for clinical trials as well as determining where to invest 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.

LDS can work with both sponsor or CRO and lab vendors to devise a process and tools so that the lab can deliver clean data to spec on demand guaranteeing the highest quality of data with the least amount of effort and time.

Specific aspects of the Lab and Biomarker Data Management process our experience covers …

  • Data Transfer Specification (DTS) including the management of how it fits into current Metadata standard including management of Codelists and Controlled Terminology
  • Vendor Agreements – both in 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
  • Automated solutions allowing lab vendor to go from PIMS extraction to validated data delivery to Sponsor/CRO with a single click

CLINICAL DATA MANAGEMENT

Our experience includes …

  • 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
  • Creation of tools for the purpose of data cleaning and query management
  • Communicating data management concerns and negotiating data delivery needs with study team including 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

LDS has played a key role in the creation of the tools and processes necessary for Metadata management for major Pharmaceutical companies. Skills and experience in this area include ….

  • Creation of Metadata Repository (MDR)
  • Creation of Processes for MDR and Metadata management and change
  • Creation of Tools to leverage efficiencies available by the MDR

CDISC CONVERSION

LDS has worked on over 200 CDSIC SDTM conversions. Aspects of the process our experience covers include …

  • Edit checks programmed in SAS or other language 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

LDS specializes, overall and across all areas of expertise, in devising tools and processes that will implement automation to the greatest extent utilizing …

  • 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 CDSIC standards or Sponsor/CRO specification in the case of lab data
  • Query management for data managed both in and outside of the clinical database
  • Electronic source data

CONTACT

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