Clinical Trials Data Management

With a comprehensive portfolio of proven data management solutions and a highly skilled team, we can collaborate on studies of all sizes.

Overview

Data Management with Integrity

Data integrity is at the forefront of our work. Our processes ensure the accuracy, completeness, and validity of your clinical trial data.

Data Collection Services

We offer a wide range of data collection solutions, including:

Secure data collection platforms

Study enrollment, randomization, and registration

Integrated quality assurance/quality control processes

Custom reports and real-time data visualizations

Monitoring Reports

We are experts in real-time data checking, custom reporting, and data visualizations to provide instant visual updates on study progress and simplify the communication of complex data.

Secure Platforms

Our secure data management platforms support:

On-demand and secure data retrieval

Data transformation and integration

Robust data backup procedures

Commercial Systems

At Frontier Science, we design and manage databases using industry standard commercial electronic data capture (EDC) systems including:

DataFax

REDCap

Medidata

OpenClinica

Custom Solutions

Our bespoke registration/randomization system, Stars, and our laboratory information management system, Laboratory Data Management System (LDMS), are used by sites and laboratories worldwide to manage the enrollment of participants and collection of biological specimens.

Standards & Regulations

Frontier Science operates in accordance with Good Clinical Practice as well as the Good Clinical Data Management Practices standards.

We adhere to international and domestic regulations, including all applicable FDA requirements, and follow CDISC standards in providing MedDRA and WHO Drug coding.

Our Data Management Team

Our knowledgeable data management team works closely with collaborators from start to finish to ensure that resulting study data are of the highest quality.

Our team contributes to protocol documents, develops procedure manuals, and designs and implements data collection instruments using applicable data standards with extensive built-in quality control.

We initialize our registration/randomization software at study start-up, process data from specialized laboratories and other non-clinical sources, develop and deliver reports, perform final data freeze and lock, and assist in preparations for interim and final analyses and other study close-out activities.

Data Management Process

  • Development

    Our team collaborates on the development of data collection instruments and study materials to meet the specific needs of the study

  • Study Conduct

    During study conduct, data managers review data in real time to ensure that they are collected, reviewed, and delivered per study specifications

  • Reporting

    We develop and publish fully customizable reports, which include data visualizations

  • Study Closure

    Our team oversees study closure activities, including database lock, and contribute to final publications and journal articles