Reston, Virginia (PRWEB) February 25, 2014
Aptiv Solutions, a global biopharmaceutical and medical device development services company leading the design and implementation of innovative approaches that improve data quality, efficiency and productivity of product development, today announced the launch of a new, streamlined process to support endpoint adjudication for drug and medical device companies.
Regulatory bodies in the EU and US now recommend centralized endpoint adjudication to assess unacceptable cardiovascular risk of new anti-diabetic drugs. Similar guidelines for drugs in other therapeutic areas will follow. Centralized endpoint adjudication is used to standardize key clinical efficacy and safety variables and to address the considerable degree of variability in clinical endpoint classification practices performed by investigators. It is a key process to maintain the integrity and quality of critical trial data.
Aptiv Solutions manages the endpoint adjudication process through a central Endpoint Coordinating Center whose staff interacts with the key stakeholders to maximize capture of suspected endpoints, collect quality supporting source documentation and obtain expert standardized adjudicated outcomes from the Clinical Endpoint Committee (CEC). CECs adjudicate on complex efficacy and/or safety endpoints. It is critical that they have easy access to high quality medical dossiers containing all essential endpoint information. Frequently utilized paper-based document exchange is an inherently slow method of knowledge transfer. The new, streamlined, electronic process offered by Aptiv Solutions is designed to benefit all endpoint adjudication stakeholders, including sites, investigators, CEC members and sponsors, by providing smooth and efficient access to data.
The collection, distribution and communication of all the necessary data and documentation that CECs need to make accurate endpoint determinations can be a labor-intensive process prone to error and delay. Through its Endpoint Coordinating Center, Aptiv Solutions establishes best practices for endpoint management, which is critical to ensure trial integrity. The Aptiv Solutions approach minimizes the complexities and logistical challenges of collecting relevant data from sites, distributing complete data packages to CEC members, and ensuring accurate communication of CEC adjudications.
“Aptiv Solutions has considerable experience in managing endpoint adjudication. The implementation of a robust electronic process for managing the lifecycle of an endpoint dossier from site to CEC represents a significant step forward in providing our clients with cutting edge solutions that maximize data quality and enhance critical decision-making,” says Dr. Michael McKelvey, Chief Operating Officer at Aptiv Solutions.
The new process is driven by AptivEndpointTM, a CFR 21 Part 11 compliant application that provides the architecture to manage the complex logistics of endpoint management. AptivEndpointTM provides interconnectivity for all stakeholders, incorporates compliant data transfer processes for collection, assembly and dissemination of standardized endpoint dossiers, enables efficient site and data query paths, enables accurate delivery of adjudication data, provides workflow tracking dashboards to sponsors and project managers, and delivers a robust audit trail.
###
About Aptiv Solutions
Aptiv Solutions is a global development services company focused on enhancing clinical trial decision-making, efficiency and productivity for pharmaceutical, biotech and medical device sponsors. It is the only CRO to offer design, simulation and execution of adaptive clinical trials and a novel statistical sampling approach to risk-based monitoring. These services span the entire product development cycle from first in human through regulatory approval to post-marketing. Aptiv Solutions has more than 850 professionals in North America, Eastern and Western Europe, Israel and Japan. Learn more at http://www.aptivsolutions.com.