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While the global need for cost-effective drugs and treatments is on a rise, so is the scrutiny of processes and expectations of the regulators, healthcare providers, payers, investors and other stakeholders. Some of the rippling effects have been growing number of mergers to blanket patent expiries and increased penetration of IT processes in the Life Sciences industry.
Silicus understands the need of synergizing the fragmented information islands of this industry by making the best use of technology. Leveraging our industry based experience and technology expertise, Silicus offers end-to-end IT services for the Life Sciences industry to enable sustainable, flexible and scalable information management, collaborative research platform, hassle-fee regulatory submissions, effortless document management, robust verification & validation process, faster IT consolidation and focused analytics for sales and marketing.
Jose Ramon Mosteiro
Ford Oxaal
Dayon Kane
John Ferrari
Umesh Verma
Dan Boehm
Bo Keyslay
Michael VaughnSoftware Product Engineering Services
Silicus works with Life Sciences ISVs and pharma start-ups to help them develop line of business applications for managing regulatory compliance, supporting clinical trials, and enabling collaboration amongst R&D teams. We strive to help you achieve radical growth and strategic value with the right implementation of IT. Our team has a wide range of experience in clinical, financial and pharma domains and can assist you with the development and maintenance of software products in a wide variety of categories, including:
- Electronic Data Capture (EDC) systems
- Systems for electronic Common Technical Document (eCTD)
- Clinical Trial Management Systems(CTMS)
- Laboratory Information Systems (LIS)
- Clinical Dashboards, Reporting and Data Analytics
- Image Analysis Software
- Drug Adverse Event Management
- Marketing and Sales applications
Custom Application Services
Silicus is highly specialized in custom development, implementation, validation and verification of IT solutions in regulated industries like Life Sciences. We are supported by an in-house team of industry experts having focused knowledge in Life Sciences processes and standards. This accentuates our capability to deliver unique and niche custom IT solutions.
Insights in compliance, expertise to deliver and proven programming techniques are the driving factors in achieving robust and secure solutions. Leveraging this knowledge and expertise, we can develop specific software to help you in the following categories:
- Regulatory Compliance
- Enterprise Integration and Collaboration Solutions
- Audit Management
- Security and Authentication
- E-Records Data Management
- Process Automation
- Testing for software Verification, Validation and Qualification
- Reporting and Analytics for Business Management
Independent Software Testing Services
It is mandatory that the implementation of technology in the Life Sciences industry should meet its intended purpose. Stringent quality requirements in FDA regulated industries impose the need for specific controls and procedures throughout the Software Development Life Cycle (SDLC). Below are some of the facts that re-enforce the necessity to have an Independent Testing partner:
- Majority of the software applications in the Life Sciences industry directly or indirectly deal with the production process; and even slight negligence can result in serious adverse consequences
- Regulatory evidences are required to be capable of standing up to close scrutiny by trained independent inspectors. Besides, the financial penalty for failing an audit can be extremely high
- To survive the stringent FDA rules, it is required to have rigorous testing and validation plans, coupled with fair assessment to gauge audit-readiness of the software against corresponding 'fit-for-use' features.
Silicus has a strong testing practice teamed with industry experts who can conduct industry-specific independent software testing.
Consulting & Professional Services
To remain progressive in the highly competitive Life Sciences industry, organizations are leaving no stone unturned to stay ahead in the league. Investing in the right IT initiatives is one of the critical steps, in order to achieve transformational outcomes. Silicus leverages its team of techo-functional industry experts to provide following consulting solutions for the Life Sciences domain:
- Gap Analysis for Regulatory Compliance like 21 CFR Part 11
- Audit-readiness Roadmap
- Security Diagnosis
- Process Consulting for Efficiency and Performance
- IT Landscape Assessment for Enterprise Integration
- Remediation Plans and Implementation Support