Our team has delivered several key projects for clients. The following are a few recent case studies of ongoing or completed projects:
Comprehensive patient recruitment, retention and engagement platform using patient lab, genomic, prescription and medical history data:
The client is one of the world's largest lab diagnostic company and is looking to leverage its data assets to optimize aspects of clinical trial recruitment and trial design. The Avigo team used our collaborative solution development methodology to perform the business analysis, current state assessment, process mapping and gap analysis. We defined the requirements for the platform and also articulated a comprehensive architecture for the cloud-based platform. In addition, the Avigo team developed the full life cycle prototypes to enable the implementation of the platform.
Development of patient communities and registries for disease-specific foundations/groups:
Avigo is currently working with a number of disease communities, foundations and coalitions to develop global patient and stakeholder system for the purposes of identifying, engaging and becoming a centralized, unique resource for patients and stakeholders. Initial work is focused on developing a next generation patient registry, community and engagement platform to enable with downstream capabilities for better patient engagement, retention and to become the go-to global resource for disease information, research and for purposes of gathering longitudinal clinical information from patients. The base system will serve to driving clinical research and related clinical trial analytics.
Clinical trial data management services, including CDISC transformations and statistical analyses:
The client, a transnational biotechnology company, needed CDISC and biostatistical support for a number of clinical studies. Avigo's team provided SEND compliance and SDTM CDISC support to the client's drug safety, DMPK and IT project stakeholders. Activities included: identifying from business process maps, business processes that are related to SEND and identifying business process changes, reviewing and providing bottom up estimate of cost, requirements/scope management plan, stakeholder management plan, resource management plan, change management plan, risk management plan, quality plan, communication plan, and a bottom up estimate of schedule detailed with a work breakdown structures, authoring data mapping plan, participating in testing and validation of SEND data sets, and reviewing testing and validation of SEND data sets
A regulatory information management solution, including xEVMPD/IDMP aspects:
The client is one of the world's largest generic drug manufacturer and needed an enterprise system to address xEVMPD/IDMP regulations as well as provide a platform for tracking and updating submissions to the EMA. Avigo provided implementation and enhancements support for an enterprise solution addressing the EMA regulations while overlaying a business logic layer that allowed the system to remain compliant with evolving regulation without requiring software re-validation. The system was integrated with the customer’s active directory system and the EMA gateway. The system enabled the company to manage a large global portfolio of products in a single system. The system supported new processes for unified data entry and reporting across the company’s entities, affiliates and partners globally and consequently allowed a number of legacy systems and Excel-based or ad hoc tools to be retired. The client was able to meet a critical EMA deadline using a 21 CFR Part 11 configured, global system managing EVMPD submissions for 14,000 products, including thousands of annual updates.
Pharmaceutical R&D system management and cGxP compliance services:
The client, an international oncology-focused biotech company, needs comprehensive application and compliance to its global portfolio of pharmaceutical R&D systems. Avigo’s team currently supports 150+ R&PhS systems (excluding additional systems and applications that have been de-commissioned over the years), including but not limited to Aperio, Spotfire, Tumor Management System, iPACS, Pipeline Pilot, ELN, Bartender, Chemical Registration System, Media Request System etc. The Avigo team also performs Level-2 user support duties for applications and systems across selected global research systems departments. Avigo's expertise and outsourced data/application services have enabled the client to arrive at an optimal support structure in a cost effective manner, without sacrificing quality and regulatory and related infrastructural, functional, process and technical requirements.