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Simplifying  Clinical Data Management

We specialize in helping pharmaceutical, biotechnology, medical device, and Clinical Research Organizations manage their Clinical Data Management needs.

About D.A.C  Consultants

Our Mission

At D.A.C., we are dedicated to providing top-notch consultancy services for pharmaceutical, biotechnology, and medical device firms, helping them effectively manage their Clinical Data Management needs. 

Services

Study Startup Activities 

  • Protocol Review 

  • Budget Review

  • CDISC/CDASH eCRF Design

  • eCRF Completion Guidelines

  • Data Management Plans

  • Data Validation Specification

  • Data Review Plans

  • UAT Testing

Study Execution and Management

  • Cross-functional Team Member

  • Vendor Management (CRO, IRT, External Labs)

  • Data Review and Query Generation/Resolution

  • ​Serious Adverse Event (SAE) Recollection

  • Database Lock Activities

  • Data Management Metrics and KPI

  • Medical Coding (MedDRA WHODrug)

  • Local Lab 

System Selection and Implementation

  • Electronic Data Capture (EDC)

    • Medidata Rave EDC​

    • Veeva EDC

    • Medrio

  • Interactive Response Technology (IRT)

  • Data Visualization Systems

    • Spotfire​

    • Tableau

    • JReview

  • ePRO/eCOA

  • eTMF

Infrastructure Development 

  • CDM Standard Operating Process (SOP) development and improvement

  • CDM Work Instructions 

  • Global Library Standards

  • Standard Documentation templates

  • Hiring and Mentoring of New CDM Staff

Vendor Selection and Qualification

  • Vendor Selection

  • Vendor Qualification

  • Assist in Vendor Audits​

Therapeutic Areas

  • Oncology

  • Infectious Disease

  • Urology

  • Diagnostics

  • Transplant

  • Endocrinology

  • Neurological

  • Gastroenterology

  • Immunology 

  • Analgesics

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