Clinical Data

[ Consulting ]

We help Life Science extract value from data.

Our subject-matter experts can help you to optimize and manage your end-to-end clinical data flow.

Future-ready Clinical Data Flow

Intilaris specializes in optimizing clinical data flow to help our clients to effectively collect, manage, understand, and interpret clinical data from both traditional and digital health sources.

Clinical Data Sources

Data Domains

Clinical Study Protocol

Study Definitions Metadata

Data Collection

Centralized Study Monitoring

Medical Data Review

Safety Data Review

Medical Device Data

Study Data Tabulation Model

ADaM Datasets

Smart Query Management

Third Party Vendor Data

Medical Coding

Data Reconciliation

Data Management Reporting

Clinical Data Validation

Data Standards

CDISC Standards









Data Exchange
Define - XML
Dataset - XML

TransCelerate Digital Data Flow (DDF)

TransCelerate DDF vision is to optimize study processes through automation of manual and repetitive processes, connecting systems to drive improved study design, data quality, and reduce cycle times.

intilaris resources have been involved in the TransCelerate DDF initiative from the start of the initiative itself, but intilaris subject matter experts have contributed to the original ideas of Structuring Study Definition (SSD) and integrating it into downstream processes for accelerated implementation. We support our clients in introducing and implementing TransCelerate DDF into their clinical development organization.

Study Definition Repository
TransCelerate DDF Consulting
Unified Study Definition Model
USD Unified Study Definition Model

Clinical Data Products

Our clinical data subject-matter experts can help you identifying the best data-product opportunities demands in the clinical domain by merging the product-and-business perspective with the tech-and-data perspective.

Data Integrity

Data integrity verifies the degree to which data collected at the point of capture, including the metadata,  is complete, consistent and accurate throughout the data lifecycle. Integrity of source data is essential for  meeting patient expectations and regulatory requirements.

We support you to ensure compliance with the regulatory guidance for data integrity. In other words, we ensure that data flow within customers IT systems maintains it’s integrity through managing the risks to impacted IT systems and the controls in place to mitigate those risks. We support you to manage the risks, controls and best practices for all types of IT systems:

  • Equipment and instrumentation
  • Enterprise-wide IT systems
  • Local IT systems

Our approach to data integrity is supporting ALCOA principle, i.e. created data is attributable, legible, contemporaneous, original and accurate. Furthermore, the data is maintained in complete, consistent, enduring and available state throughout its lifecycle.