Clinical Data Management.

Experience the next level of data flow and security in clinical trials.

Our clinical data managers help you successfully conduct all phases of clinical research from trial and site setup to the final database export and archive and across all therapeutic areas. According to your needs, we can manage the complete trial process, or accommodate a specific service.

Our Oomnia® EDC/CTMS system facilitates streamlined, effective data collection processes, assures data quality and integrity, and resolution of data discrepancies.

Professional Services

Study Set-Up
Study Conduct
Study Close Out
Study Set-Up

eCRF/CRF design

eCRF annotation

eCRF implementation and validation

Automatic edit check and trigger setup

EDC document creation, including Monitoring Visit Reports

WebPRO and/or ePRO

Setup / programming of custom on-demand reports

eCRF Validation Report writing

Clinical Data Management Plan writing

Data Transfer Plan writing

Setup of external data transfers, including integration with pharmacovigilance, medical coding, and reporting systems

Study Conduct 

Data acquisition and storage management

Data review

Query management

Data transfers with pharmacovigilance and other systems as necessary

Safety data management and (S)AE reconciliation

Custom in-trial reports

Custom data exports

Interim analysis

Double data entry

Real-time data review and reporting

Study Close Out

Soft database lock

Data preparation and cleaning

Hard database lock

Clinical data management report writing

Database export

Conversion of data to standard deliverables (CDASH, SDTM)

Study close out documentation

Study archiving


Exceptional EDC Solutions

Reduce costs by creating reusable or study-specific EDC forms that will guide your team through the trial process with clarity and transparency. Our experts can create any type of EDC form, including custom reports and logs.

Flexible And Efficient Process

Meet study timelines in all trial phases with excellent data management planning and organization solutions. Our data management approach facilitates rapid eCRF and EDC form creation with seamless mid-study changes.

Database Proficiency

Expedite your workflows by using a smarter and more streamlined approach to all database processes. All EDC forms created in our system automatically generate auto-validating databases, thus ensuring absolute data precision and integrity throughout the entire data lifecycle.

Superior Data Quality

Improve your trial efficiency, rely on accurate data. Our auto-validating databases preclude the possibility of incongruent datasets, which, when combined with our custom and effective data management framework, ensure the highest data integrity levels.

Rapid External Integration

Stop unnecessary reconciliation of data from disparate vendors and collaborators and improve the performance of your teams. We integrate data from different systems, including electronic healthcare records, local and central laboratories, healthcare information systems, and more.

Timely Deliverables

Our vertically integrated data management, Oomnia® EDC/CTMS system, and statistical services ensure efficient and timely deliverables. Our team is well versed and uses integrated SOPs to reduce communication times and ensure high quality, timely deliverables.

Let us discuss how we can help you streamline your data.

Get in touch with us