A web-based application developed for use by the Regulatory Operations and Affairs department within one of our pharmaceutical clients. The system is required to provide access to the regulatory status of our client’s products worldwide by tracking the regulatory life cycle of a product from the time of an estimated dossier dispatch or submission through the time the product is approved and launched in a market. 

The objectives for the design of the database were to provide a user friendly, comprehensive, web-based application that enables real-time access to a broad range of regulatory information. Furthermore, the system needed to enable data entry at various points throughout the regulatory process and provide users with extensive search and reporting capabilities. The system was designed to be an internationally shared reference tool for our client, which can be accessed anywhere in the world provided the user has an account to the system and access to the corporate intranet.

Another web-based application developed for use by the manufacturing divisions within one of our pharmaceutical clients. The purpose of the CMC dB is to maintain drug product and ingredient registration or technical dossier information for our client’s products so that the site compliance personnel may verify this information at the manufacturing sites. In addition, our client’s change control efforts are supported by the system through provision of reliable key registration information. Other initiatives such as Supply chain consolidation efforts are facilitated by registration information provided through the CMC dB repository. 

This project included the development of a customized workflow engine for tracking drug product status, assigning daily tasks to system users, and sending change notifications to users and management responsible for a product.

An application within one of our clients to define and disseminate security standards information to corporate employees and raise colleague awareness for information protection. Work in this area included a requirements definition, which provided conceptual designs for a Business Continuity Planning/Disaster Recovery Planning tool, an IT compliance review of legal and regulatory requirements, development of an information security audit checklist, and ensuring compliance with Information Protection Guidelines within each business unit of the organization.

This was developed for the Medical Services department of one of our pharmaceutical clients. The application includes approximately twenty reports that derive data from two separate instances of an adverse events management application, one based in the United States and one in the United Kingdom. Although adverse events data are available through an adverse events management application, the inherent querying capability of the application does not provide the flexibility the client requires. The objective of the reporting application, therefore, is to provide role-based access to adverse events data through a series of "canned" or pre-formatted reports. These reports will support the specific requirements of the Medical Services groups in the US and the UK in terms of adverse events reporting to their respective regulatory authorities, and will provide head office in Japan with, for example, metrics regarding turnaround time for adverse events reporting.

This was a project for the Pharmacovigilance department at a world-wide leader in the pharmaceutical industry. Avelient manages the reporting and analysis team which is responsible for the production of all aggregate safety reports (PSUR, ASR, QSR, IND, NDA) as well as validated ad-hoc reporting in support of the aggregates and other health authority submissions. Avelient is responsible for metrics reporting, work prioritization with senior management, resource management and workload balancing in this variable environment. The team produces an average of 325 reports per month and meets service level agreements 98% of the time.

During this engagement, the client implemented the Oracle Adverse Event Reporting System (AERS). Avelient led the transition of aggregate reports from the legacy system to AERS. This effort included requirements gathering, business and technical process definition, system configuration, piloting the aggregate reports and training the user base.