Our Services and Methodology

For each project, we develop a data management plan (DMP) that identifies the study-specific quality control steps that we will take to review the data for accuracy and completeness. We identify key edits and variables to display frequencies and ranges by site and examine outliers, missing data, and other potential anomalies. We also scrutinize eligibility, safety, and variables associated with the primary endpoints. Our integrated multidisciplinary cross-functional teams use eClinical solutions to drive data cleaning processes and to ensure quality, data-driven productivity. Our data management best practices and established procedures align with operational management, continuous technology improvement, and clinical data standardization and integration.

We have implemented the Electronic Case Report Form (eCRF) Library, which contains de-identified forms from the Clinical Data Interchange Standards Consortium (CDISC) and previous clinical trials we supported in the past. Because the eCRFs have already undergone quality control testing, it speeds the development of EDC applications and data management. Our staff can select from hundreds of CRF and database table templates. And as we reuse core and study specific forms for each study, we continue to save our clients time and money.

Data Standardization Support

Data Development and Implementation

Clinical trial data standardization is one of our strongest and most in-demand services. We have helped to create industry-wide CDISC data standards, author several CDISC therapeutic and disease-specific standard user implementation guides, and contribute to the development of CDISC controlled terminology and questionnaire standards. KAI’s standard document template, mapping specification and traceability, programming, validation, and streamlined processes of CDISC SDTM, Controlled Terminology, ADaM, and Define.xml ensure accurate interpretation and implementation of the CDISC standard models to the study data life cycle, study protocol, and statistical analysis plan, and support KAI’s CDISC implementation service to our clients for U.S. Food and Drug Administration (FDA) submission.

We are experienced in developing and vetting common data elements (CDEs) in specific therapeutic areas for both government and industry clients. We have assisted every aspect of the CDE development process, from assembling expert working groups of national and international clinical research experts to creating and publishing CDE metadata. In addition, we have colla¬borated with multiple organizations to harmonize CDEs for consistency and reusability.

Metadata and Data Warehousing

In today’s clinical trials, data are often stored in multiple databases or data collection systems at contract research organizations, electronic data capture vendors, sponsors, investigator sites, or laboratories. These databases are often nonstandard and proprietary. Our clinical data warehouse solution provides a centralized, integrated system for data storage, analysis, reporting, and ad hoc queries of clinical data. This solution enables standardization of clinical data, efficiency in project programming, and data discovery options, which can improve the overall drug development process.

We conduct data standardization and manage metadata platforms for several government contracts, developing and registering metadata to support clinical system interoperability, data collection, data management, and data governance throughout the data life cycle. In addition, we can streamline multiple data sources into a single metadata-driven unified data repository.

eClinical Systems Support

Our suite of eClinical solutions includes:

Clinical Data Management System (CDMS) — OpenClinica® Enterprise System is a full-featured, web-enabled CDMS that supports electronic data capture and can support electronic or paper case report forms. It is validated according to 21 CFR 11, and is CDISC-compliant. Our seasoned programmers and data managers have supported the use of both proprietary and non-proprietary systems as required by our clients.

Clinical Trial Management System (CTMS) — Smart Trial™© is a web-based, scalable CTMS that provides users with secure, stable, centralized access to trial administration data and documents at the sponsor, trial, investi¬gator, or site level. From the centralized website, the following functions can be carried out and/or tracked: site management; study participant recruitment; storage and maintenance of required regula¬tory documents; scheduling of monitoring visits; report preparation and access; drug shipment; laboratory data tracking; site payment scheduling and processing; and automated alerts and notifications.

Interactive Voice Recognition (IVR) — This is a validated system created by Telesage, Inc., for web-based or telephone randomization, dose assignment, and tracking, which we have used in numerous clinical trials, registries, and surveys.

Electronic Patient Reported Outcomes (ePRO) — We developed this web-based system which includes a simple and intuitive user interface design, on-form data validation warning messages and skip patterns, robust and real-time reporting modules. It provides the rapid development of easy-to-use, valid electronic assessment forms and the corresponding database. Our team expertly develops assessment forms that reflect the information contained in source documents and has provided this service for a wide variety of projects.

ARISg™ — This commercial adverse event tracking and reporting system incorporates MedDRA coding. The system is designed to meet current and future FDA standards for electronic data submissions.

Electronic Trial Master Files (eTMF) — We manage eTMFs with a secure web system. During the study set-up phase, we review and evaluate the content of the eTMF based on the study protocol and sponsor requirements for the trial-specific list and set it up according to the DIA Trial Master File Reference Module. We create a study directory on the eTMF server and organize levels of subdirectories according to the metadata sheet. The eTMF web interface provides study team members easy but secured access to the controlled documents. File upload and download are encrypted processes to minimize the likelihood of interception or modification of data during transmission.

Work with us. Contact us to learn how we can find the right solutions for all of your clinical research needs.

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