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ClinDART, Inc.

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ClinDART, Inc.

ClinDART is a strategic clinical data partner delivering flexible, full-scope data services to sponsors across all phases of clinical development. We combine deep technical expertise with practical operational insight to design, build, and manage high-quality clinical data environments that accelerate development timelines and reduce regulatory risk. Our services are delivered as standalone solutions or integrated across single or multi-study programs through scalable, customized resourcing models.

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Locations

  • North America
Overview Accreditations / Enablement

Therapeutic Areas

  • Cardiovascular
  • CNS
  • Dermatology
  • Devices and Diagnostics
  • Diabetes
  • Gastroenterology
  • Immunology
  • Infectious Diseases
  • Inflammation
  • Metabolic Diseases
  • Neurology
  • Obstetrics / Gynecology
  • Oncology
  • Ophthalmology
  • Orthopedics
  • Other
  • Pain / Anesthesia
  • Psychiatry
  • Pulmonary
  • Sleep
  • Urology
  • Women's Health

Clinical Data Strategy & Consultation

We partner with sponsors early to build the right data foundation from day one.

  • Full-scope clinical trial data strategy
  • Study design analysis and data architecture planning
  • Medidata system selection, implementation, and optimization support
  • Upgrade strategy and lifecycle management

Outcome: Efficient database builds, streamlined execution, and long-term scalability.

Clinical Data Management & Programming

ClinDART delivers robust, compliant, and sponsor-ready data solutions.

  • Custom data management and programming models
  • CDISC-compliant database design (SDTM, CDASH)
  • Database build, validation, and ongoing administration
  • Clinical laboratory data integration and reconciliation
  • External vendor data oversight and batch loading
  • Oversight of CRO Data Management team

Outcome: Clean, submission-ready datasets with reduced downstream rework.

Statistical & Technical Programming

Our programming team ensures regulatory precision and analytical clarity.

  • SAS programming and statistical outputs
  • CDISC submission package preparation
  • Data conversion and standards alignment
  • Custom reporting, dashboards, and data visualization

Outcome: Accurate, inspection-ready deliverables that support confident decision-making.

Operational & Safety Support

We extend beyond data to provide critical oversight and clinical insight.

  • Rescue Studies
  • Safety data management and oversight
  • Non-MD Clinical Science review for protocol interpretation and data review

Outcome: Strengthened data integrity and improved cross-functional alignment.

Accreditations / Enablement

Partners are trained on the functionality of the Coder application, process optimization, and scope of Coder services. This Accreditation teaches Partners to integrate the medical coding solution with EDC studies and administer Coder segments. Coder Accreditation is dependent on the successful completion of the Rave EDC accreditation.
Partners are trained on the functionality of the electronic data capture (EDC) and clinical data management (CDM) system, process optimization exercises and scope of Medidata Rave services. This Accreditation teaches the staff to perform end user training, user and site administration, study build, reporting, outputs and amendment manager.