Ensuring Our Customers’ Life Sciences Success
Over last three decades, Aris Global has helped over 300 companies improve their drug development processes. Our customer include leading pharmaceutical companies, biotech companies, CROs, medical device companies and regulatory agencies. We work with more than half of the top 50 pharmaceutical companies. Our mission is to help companies and authorities meet regulatory requirements, manage risk and improve operational efficiencies
Aris Global provides end-to-end business technology services that help organizations identify and improve areas within drug development through process optimization and data integration, plug the gaps through application development, and reduce the total cost of ownership of operations through offshoring shared services.
Pharmaceutical, biotechs and medical device companies bear a high cost of developing new treatments and in bringing them to market with the greatest safety and speed. Aris Global can help businesses achieve significant cost savings by focusing on two main levers of making the drug development processes more efficient. First, our highly trained staff helps optimize the processes and makes them “lean” by eliminating waste and redundant activities. Second, we help organizations improve access to relevant data by integrating key data sources.
- Process optimization:
We offer metrics-driven process optimization in drug safety, clinical and regulatory operations. We identify the key metrics that are aligned to your business objectives, create initial baselines of those metrics, identify the desired future state, and then identify a roadmap of improvements needed to achieve the stated targets.
The typical approach to process optimization does not work in the drug development area. This is due to the stringent validation requirements and the time taken to realize large changes. Instead of a “big bang approach,” Aris Global will work with your organization to implement an incremental approach that targets a small number of areas at a time, which will provide faster benefits without disrupting the operations.
- Standards & integration:
Data integration improves the productivity of drug development process by providing the right information at the right time. Standards-based data integration can considerably improve drug development efficiency. Aris Global consultants help develop and implement the strategy for data integration and standards adoption.
Improving business alignment
Aris Global helps improve the alignment of an organization's IT portfolio with the business needs by identifying the gaps and developing applications to address the gaps. Our staff focus areas are:
- Safety report development:
Drug development generates two types of data:
1) subject-based data essential for scientific/safety analysis and
2) metrics data essential for effective operations.
The data is typically collected across multiple systems and geographies. We have helped a number of companies develop safety reports with lower cost and faster time to market.
- Data warehouse development:
Aris Global has helped a number of clients implement their safety / clinical data sources for safety as well as metrics reporting. We have a well-defined framework and accelerators to implement a business intelligence solution in the drug development space. We can leverage these to reduce the risk and time taken to design and implement safety or clinical data warehouses.
- Package implementations:
We offer extensive experience in implementation of packages in drug development using our global delivery model. Our methodology is well tested and complies with the regulatory requirements (GXP, 21 CFR Part 11). We can help reduce the risk, cost and time to market for package implementations by leveraging our proven methodology, deep functional expertise and global delivery model.
Reducing operating cost
Aris Global lowers the operating cost of maintaining applications by creating offshore-based shared services. Our consultants help set up the shared services for the following areas:
- Application support:
Most drug development organizations face challenges in application support due to inability of the support staff to understand the business context of the issues. Our Application and support group combines the drug development process knowledge and the ITIL compliant support processes to provide an efficient and cost effective application support service.
- Testing & validation:
We provide end-to-end testing and validation services that help pharmaceutical companies achieve a validated state in a compliant and cost-effective manner. We have extensive experience in testing validated applications. Our independent team is trained in testing drug safety, clinical and regulatory processes. Our better understanding of domain and extensive experience enables us to reduce the risk and total cost of testing and validation.
Given the fear of non compliance to regulations, most companies do not consider optimizing the cost of compliance. However, given the unstructured evolution of quality and compliance environments, there are significant opportunities for cost savings. The cost of quality and compliance itself is significantly high and growing. While all areas are considered high priority from a compliance perspective, the high cost may also be due to several factors that typically evolve due to history (e.g., mergers and acquisitions) or resistance to automation. Aris Global consultants perform an in-depth analysis of such factors is needed to develop a long term strategy for reducing the cost of quality and compliance.
Aris Global works only in the drug development area and thereby provides significant benefits:
- We offer a deeper understanding of issues and challenges affecting drug development
- All employees are trained in drug development processes and regulations. A large number of our employees have spent significant time in the industry.
- We 'hit the ground running' delivering immediate value to you
- Strong domain knowledge with our technical competency to develop comprehensive suite of products in the drug safety, clinical and regulatory areas
- Our processes are tailored to meet the requirements of life sciences industry.