Life Sciences

The goal of every organization within the life sciences, pharmaceutical and healthcare domain, from discovery through manufacturing, is to reduce time-to-market at the same time be compliant with the FDA regulations (GxP, 21 CFR Part11 etc.) By implementing new processes and technologies, businesses can achieve both objectives and at the same time reduce cost. Technology is playing a very important role in achieving these business objectives. Technology has become integral part critical business functions such as of clinical development (labs and manufacturing automation), supply chain and manufacturing. It is not only used in day-to-day operations in labs (data collection, management and archiving) and manufacturing, but also to build up a competitive advantage (DW/BI, Knowledge Management).

EC-Manage, Inc. Services and Competencies

EC-Manage, Inc. helps life science and pharmaceutical companies reduce “Time-to-market” by offering solutions and services such as system implementation (development and/or integration), system validation, and project management in areas like:

Laboratory Data Management (LIMS, Long term Archiving, eNoteBook)

EC-Manage, Inc. has expertise in integrating laboratory systems utilizing a variety of tools and custom interfaces. We help you maximize your investments by integrating your laboratory information management systems (LIMS), scientific data acquisition systems, long-term archiving systems, and electronic laboratory notebooks.

At EC-Manage, Inc., we offer our expertise and capabilities either in new implementation initiatives or for upgrades or customizations of existing systems. We offer services at any phase of a project, from assessment until the final production rollout. Our proprietary system implementation and project management methodology helps us implement quality driven systems keeping your business goals in mind.

Regulatory Compliance

Regulatory compliance is a key factor determining success in the pharmaceutical industry. Since companies are regulated by FDA, it is critical that the technologies used for supporting business processes must be compliant with FDA regulations such as GxP and 21 CFR Part 11. Implementation of a validated system typically adds 25% to 50% to total system cost. Companies must develop cost-effective strategies and relationships with experienced validation partners to achieve efficiencies that will as a result mitigate cost.

EC-Manage, Inc. services can help organizations like yours with cost-effective solutions to implement processes and technologies to mitigate risk of non-compliance.

Clinical and Supply Chain Data Integration

Most of the pharmaceutical and Biotech companies use multiple Clinical Research Organizations (CROs) for clinical trial management. Due to lack of advanced technology in the third world countries, IVR systems are used to manage dispensing drugs to patients. Every clinical trial is custom developed and validated hence results in loss of time and productivity. Most of the time CROs and their clients work in silos. Data exchange is done either manually or via email thus resulting in redundancy.

Companies can achieve significant ROI in terms of increase in productivity and reduction in time if they integrate their internal applications (such as trial management, clinical data management, and supply chain) with CRO applications.

At EC-Manage, Inc., we offer XML based open architecture that standardizes the data communication between the internal and external systems and hence reduces the clinical study setup, increasing the productivity and ensuring data reliability.

Knowledge Management

Providing the “right information to right people at right time” is very critical for decision-making. Many business critical decisions and strategies fail due to lack of facts (historical data) or not getting the information required at right time.

Today, Knowledge Management with help of technologies such as Data Warehousing (DW) and Business Intelligence (BI), Content Management could play a crucial role in making right decisions in time thus reducing waste (in money and time) and generating a competitive edge.

Although the knowledge management initiative is corporate-wide, you can implement knowledge management for smaller business units or departments. These smaller knowledge management systems have helped lower costs, improved productivity and achieved regulatory compliance for departments such as R&D, manufacturing, sales and marketing.

Our core competencies include:

IT Strategy
Program and Project Management
Application Maintenance & Support
Application Testing

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SAP Life Sciences Solutions